← Product Code [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN) · K173471

# DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic (K173471)

_Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Jan 8, 2018 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K173471

## Device Facts

- **Applicant:** Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- **Product Code:** [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN.md)
- **Decision Date:** Jan 8, 2018
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1550
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Pediatric

## Intended Use

Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

## Device Story

The DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 is a mobile, software-controlled diagnostic ultrasound system. It uses an array of transducers (linear, convex, phased) to transmit ultrasonic energy into the body and process received echoes. The system generates images in B-mode, M-mode, PW-mode, CW-mode, Color-mode, Color M-mode, Power/Dirpower mode, TDI mode, 3D/4D mode, and Elastography, or combined modes (e.g., B/M-mode). It is used in clinical settings by healthcare professionals to visualize anatomic structures and analyze fluid flow. The output is displayed on-screen for clinical assessment, supporting diagnosis and patient management.

## Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including acoustic output measurements, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety testing in accordance with recognized standards (e.g., IEC 60601-1, IEC 60601-2-37, ISO 10993-1).

## Technological Characteristics

Mobile diagnostic ultrasound system; utilizes linear, convex, and phased array transducers. Supports B, M, PW, CW, Color, Color M, Power/Dirpower, TDI, 3D/4D, and Elastography modes. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and NEMA UD 2-2004. Software developed per IEC 62304.

## Regulatory Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

## Predicate Devices

- DC-8 ([K170277](/device/K170277.md))

## Reference Devices

- Resona 7 ([K171233](/device/K171233.md))
- DC-70 ([K163690](/device/K163690.md))
- M9 ([K171034](/device/K171034.md))

## Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Shenzhen Mindray Bio-medical Electronics Co., LTD. % Yang Zhaohui Engineer of Technical Regulation Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan ShenZhen, GangDong 518057 P.R. CHINA

January 8, 2018

Re: K173471

Trade/Device Name: DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 1, 2017 Received: November 8, 2017

Dear Yang Zhaohui:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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## Page 2 - Yang Zhaohui

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D'Hara For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known)

K173471

Device Name

DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System

Indications for Use (Describe)

The DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-raginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel, urology and transesophageal (Cardiac) exams.

| Type of Use (Select one or both, as applicable)                                                                  |                                                                                          |
|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| <span> <span style="font-size: large;">✔</span> Prescription Use (Part 21 CFR 801 Subpart D)             </span> | <span>                 ☐ Over-The-Counter Use (21 CFR 801 Subpart C)             </span> |

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| System:                                                                                             | DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-------------------|-----|-----|------------------|----------------------|-----------------------|-----------------------------------|--------------------|-----------------|
| Transducer:                                                                                         |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
| Intended Use:                                                                                       | Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
| Clinical Application Mode of Operation                                                              |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
| General (Track 1 Only)                                                                              | Specific (Track 1 & 3)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | B                 | M                 | PWD | CWD | Color Doppler    | Amplitude Doppler    | Combined (specify)    | Other (specify)                   |                    |                 |
| Ophthalmic                                                                                          | Ophthalmic                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
| Fetal Imaging & Other                                                                               | Fetal                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    | P                 | P                 | P   | P   | P                | P                    | P                     | Note 1, 2, 3, 4,6,7               |                    |                 |
|                                                                                                     | Abdominal                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | P                 | P                 | P   | P   | P                | P                    | P                     | Note 1, 2, 3, 4, 6, 7, 10, 11, 12 |                    |                 |
|                                                                                                     | Intra-operative (Specify*)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | P                 | P                 | P   |     | P                | P                    | P                     | Note 1,2,4                        |                    |                 |
|                                                                                                     | Intra-operative (Neuro)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Laparoscopic                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Pediatric                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | P                 | P                 | P   | P   | P                | P                    | P                     | Note 1, 2, 3,4,6,7                |                    |                 |
|                                                                                                     | Small Organ (Specify**)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | P                 | P                 | P   |     | P                | P                    | P                     | Note 1,2, 4,7,8                   |                    |                 |
|                                                                                                     | Neonatal Cephalic                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | P                 | P                 | P   | P   | P                | P                    | P                     | Note 1,2, 4,6,7                   |                    |                 |
|                                                                                                     | Adult Cephalic                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           | P                 | P                 | P   | P   | P                | P                    | P                     | Note 1, 2,4, 6,7                  |                    |                 |
|                                                                                                     | Trans-rectal                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             | P                 | P                 | P   |     | P                | P                    | P                     | Note 1, 2, 3,4,6,7,8              |                    |                 |
|                                                                                                     | Trans-vaginal                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | P                 | P                 | P   |     | P                | P                    | P                     | Note 1, 2, 3,4,6,7,8              |                    |                 |
|                                                                                                     | Trans-urethral                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Trans-esoph. (non-Card.)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Musculo-skeletal (Conventional)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          | P                 | P                 | P   | P   | P                | P                    | P                     | Note 1, 2, 4,6,7                  |                    |                 |
|                                                                                                     | Musculo-skeletal (Superficial)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           | P                 | P                 | P   |     | P                | P                    | P                     | Note 1,2, 4,7                     |                    |                 |
|                                                                                                     | Intravascular                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
| Cardiac                                                                                             | Cardiac Adult                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | P                 | P                 | P   | P   | P                | P                    | P                     | Note 1, 2,4,5,6,7,9               |                    |                 |
|                                                                                                     | Cardiac Pediatric                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | P                 | P                 | P   | P   | P                | P                    | P                     | Note 1, 2,4,5,6,7                 |                    |                 |
|                                                                                                     | Intravascular (Cardiac)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Trans-esoph. (Cardiac)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | P                 | P                 | P   | P   | P                | P                    | P                     | Note 1, 5,6                       |                    |                 |
|                                                                                                     | Intra-cardiac                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
| Peripheral vessel                                                                                   | Peripheral vessel                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | P                 | P                 | P   |     | P                | P                    | P                     | Note 1, 2, 4,6,7                  |                    |                 |
|                                                                                                     | Other (Specify***)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | P                 | P                 | P   |     | P                | P                    | P                     | Note 1, 2, 4,6,7                  |                    |                 |
|                                                                                                     | N=new indication; P=previously cleared by FDA; E=added under Appendix E                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power + PW +B.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | *Intraoperative includes abdominal, thoracic, and vascular                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | ** Small organ-breast, thyroid, testes.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | ***Other use includes Urology.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
| System:                                                                                             | DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
| Transducer:                                                                                         | C5-1E                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
| Intended Use:                                                                                       | Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
| Clinical Application                                                                                | Mode of Operation                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
| General (Track<br>1 Only)                                                                           | Specific (Track 1 & 3)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | B                 | M                 | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify)                   |                    |                 |
| Ophthalmic                                                                                          | Ophthalmic                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
| Fetal Imaging<br>& Other                                                                            | Fetal                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    | P                 | P                 | P   |     | P                | P                    | P                     | Note 1, 2, 4,6,7                  |                    |                 |
|                                                                                                     | Abdominal                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | P                 | P                 | P   |     | P                | P                    | P                     | Note 1, 2, 4, 6, 7,<br>10, 11, 12 |                    |                 |
|                                                                                                     | Intra-operative (Specify*)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Intra-operative (Neuro)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Laparoscopic                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Pediatric                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | P                 | P                 | P   |     | P                | P                    | P                     | Note 1, 2, 4,6,7                  |                    |                 |
|                                                                                                     | Small Organ (Specify**)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Neonatal Cephalic                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Adult Cephalic                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Trans-rectal                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Trans-vaginal                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Trans-urethral                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Trans-esoph. (non-Card.)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Musculo-skeletal<br>(Conventional)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | P                 | P                 | P   |     | P                | P                    | P                     | Note 1, 2, 4,6,7                  |                    |                 |
|                                                                                                     | Musculo-skeletal<br>(Superficial)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Intravascular                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
| Cardiac                                                                                             | Cardiac Adult                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Cardiac Pediatric                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Intravascular (Cardiac)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Trans-esoph. (Cardiac)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Intra-cardiac                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
| Peripheral<br>vessel                                                                                | Peripheral vessel                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | P                 | P                 | P   |     | P                | P                    | P                     | Note 1, 2, 4,6,7                  |                    |                 |
|                                                                                                     | Other (Specify***)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | N=new indication; P=previously cleared by FDA(K171233); E=added under Appendix E                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Additional comments: Combined modes--B+M PW+B Color+B Power + B PW+Color+B Power + PW +B.<br>*Intraoperative includes abdominal, thoracic, and vascular                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | **Small organ-breast, thyroid, testes.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | ***Other use includes Urology.<br>Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Note 2: Smart3D                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Note 3:4D(Real-time 3D)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Note 4: iScape                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Note 5: TDI                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Note 6: Color M                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Note 7: Biopsy Guidance                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |                   |                   |     |     |                  |                      |                       |                                   |                    |                 |
|                                                                                                     | Note 8: Elastography…

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K173471](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K173471)

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