DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System

K163690 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Apr 20, 2017 · Radiology

Device Facts

• Record ID: K163690
• Device Name: DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Apr 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The DC-70/ DC-70T / DC-70 Pro/ DC-70 Exp/ DC-75/ DC-78/ DC-70S 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 and adult cephalic, trans-rectal, trans-vaginal, Trans-esoph(Cardiac), musculo-skeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel and urology exams.

Device Story

Software-controlled diagnostic ultrasound system; acquires/displays ultrasound data via various modes (B, M, PW, CW, Color, Power/Dirpower, THI, iScape, 4D, Smart3D, TDI, Color M, Elastography, Biopsy Guidance, Contrast imaging). Uses linear and convex array probes (2.0–10.0 MHz). Operated by clinicians in clinical settings. Transforms ultrasonic echoes into anatomical/fluid flow images for diagnostic visualization and measurement. Output aids clinical decision-making by providing real-time anatomical assessment and flow analysis, benefiting patients through non-invasive diagnostic imaging.

Clinical Evidence

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

Technological Characteristics

Software-controlled ultrasound system; linear and convex array transducers (2.0–10.0 MHz). Modes: B, M, PW, CW, Color, Power/Dirpower, THI, iScape, 4D, Smart3D, TDI, Color M, Elastography, Biopsy Guidance, Contrast imaging. Compliance with AAMI/ANSI ES60601-1, IEC 60601-2-37, ISO 10993-1. Standalone system.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates. Used for fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal/adult cephalic, trans-rectal, trans-vaginal, trans-esophageal (cardiac), musculoskeletal (conventional, superficial), adult/pediatric cardiac, peripheral vessel, and urology exams.

Regulatory Classification

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-70 (K150204)
• DC-8 (K150080)
• Resona 7 (K162267)
• DC-60 (K152545)
• EPIQ 5 (K160807)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three heads, depicted in a simple, line-art style.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. April 20, 2017 YANG ZHAOHUI ENGINEER OF TECHNICAL REGULATION MINDRAY BUILDING, KEJI 12TH ROAD SOUTH HI-TECH INDUSTRIAL PARK NASHAN, SHENZHEN 518057 CN

Re: K163690

Trade/Device Name: DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, LLZ Dated: March 30, 2017 Received: April 4, 2017

Dear Mr. Yang:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D.'Hara

For

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known)

K163690

Device Name

DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System

Indications for Use (Describe)

The DC-70/ DC-70T / DC-70 Pro/ DC-70 Exp/ DC-78/ DC-78/ DC-70S 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 and adult cephalic, trans-rectal, trans-esoph(Cardiac), musculo-skeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel and urology exams.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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#### Diagnostic Ultrasound Indications For Use Format

DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer:
шиниси N/A

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

| Clinical Application | | Mode of Operation | | | | | | | |
|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|---------------------|
| General<br>(Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | 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, 4,6,7,9 |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2, 4,6,7 |
| | Small Organ (Specify**) | P | P | P | | P | P | P | Note 1,2, 4,7,8 |
| Fetal<br>Imaging &<br>Other | 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 |
| | 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 | Note 1,2,4,6,7,8 |
| | Musculo-skeletal (Superficial) | P | P | P | | P | P | P | Note 1,2,4,7,8 |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | P | Note 1,2,4,5,6,7 |
| | Cardiac Pediatric | P | P | P | P | P | P | P | Note 1,2,4,5,6,7 |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | N | N | N | N | N | N | N | Note 1, 5,6 |
| | Intra-cardiac | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | | P | P | P | Note 1,2,4,6,7,8 |
| | 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. | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | |
| | Note 4: iScape | | | | | | | | |
| | Note5: TDI | | | | | | | | |
| | Note6: Color M | | | | | | | | |
| Note7: Biopsy Guidance | | | | | | | | | |
| | Note8: Elastography | | | | | | | | |
| | Note 9: Contrast imaging | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | |
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | | | | | | | | | |

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| System: | DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System |
|-------------|-----------------------------------------------------------------------------------|
| Transducer: | C5-2E |

| | Clinical Application | | | | | | | | |
|-----------------------------|---------------------------------|---|---|-----|-----|------------------|----------------------|-----------------------|--------------------|
| General<br>(Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Abdominal | P | P | P | | P | P | P | Note 1, 2, 4,6,7,9 |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Small Organ (Specify**) | | | | | | | | |
| Fetal<br>Imaging &<br>Other | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal (Conventional) | P | P | P | | P | P | P | Note 1, 2, 4,6,7 |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| Cardiac | 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***) | | | | | | | | |

1 Parisation
Hitchuru
Hearthern Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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| System: | DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System |
|-------------|-----------------------------------------------------------------------------------|
| Transducer: | C11-3E |

| Clinical Application | | | Mode of Operation | | | | | | | |
|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------|-------------------|-----|-----|--------------------------|----------------------|-----------------------|------------------|-----------------|
| General<br>(Track 1) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | |
| | Small Organ (Specify**) | | | | | | | | | |
| Fetal<br>Imaging &<br>Other | Neonatal Cephalic | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | |
| Cardiac | 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(K150204); 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 etc. | | | | | | | | | |
| | **Small organ-breast, thyroid, testes. | | | | | | | | | |
| ***Other use includes Urology. | | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | |
| | Note5: TDI | | | | | | | | | |
| | Note6: Color M | | | | | | | | | |
| | Note7: Biopsy Guidance | | | | | | | | | |
| | Note8: Elastography | | | | | | | | | |
| | Note 9: Contrast imaging | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |
| | Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | | | | | | | | | |
| | Clinical Application | Mode of Operation | | | | | | | | |
| General<br>(Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal<br>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 | |
| | Pediatric | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Small Organ (Specify**) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| Cardiac | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | | | | | | | | | |
| | Other (Specify***) | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(K150204); 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 etc. | | | | | | | | | |
| | **Small organ-breast, thyroid, testes. | | | | | | | | | |
| | ***Other use includes Urology. | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | |
| | Note 3: 4D(Real-time 3D) | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | |
| | Note5: TDI | | | | | | | | | |
| | Note6: Color M | | | | | | | | | |
| | Note7: Biopsy Guidance | | | | | | | | | |
| | Note8: Elastography | | | | | | | | | |
| | Note 9: Contrast imaging | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | | | | | | | | | | |
| Clinical Application | | | | | | | Mode of Operation | | | |
| General<br>(Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | | Note 1, 2, 4,7 |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | | Note 1, 2, 4,7 |
| | Small Organ (Specify**) | P | P | P | | P | P | P | | Note 1,2, 4,7,8 |
| Fetal<br>Imaging &<br>Other | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal (Conventional) | P | P | P | | P | P | P | | Note 1, 2, 4,7 |
| | Musculo-skeletal (Superficial) | P | P | P | | P | P | P | | Note 1, 2, 4,7 |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | | P | P | P | | Note 1, 2, 4,7 |
| | Other (Specify***) | | | | | | | | | |
| Clinical Application | | | | | | | Mode of Operation | | | |
| General<br>(Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal<br>Imaging &<br>Other | Fetal | | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | | Note 1,2, 4,7 |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | | Note 1,2, 4,7 |
| | Small Organ (Specify**) | P | P | P | | P | P | P | | Note 1,2, 4,7,8 |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal (Conventional) | P | P | P | | P | P | P | | Note 1,2, 4,7 |
| | Musculo-skeletal (Superficial) | P | P | P | | P | P | P | | Note 1,2, 4,7 |
| | 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, 4,7 |
| | Other (Specify***) | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA(K150204); | | | | | 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 etc. | | | | | | | | | |
| | **Small organ-breast, thyroid, testes. | | | | | | | | | |
| | ***Other use includes Urology. | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | |
| | Note5: TDI | | | | | | | | | |
| | Note6: Color M | | | | | | | | | |
| | Note7: Biopsy Guidance | | | | | | | | | |
| | Note8: Elastography | | | | | | | | | |
| | Note 9: Contrast imaging | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |
| | Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | | | | | | | | | |

I Tanback
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

{6}------------------------------------------------

DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: C C7-3E
Intenueu
Home Diagno

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

{7}------------------------------------------------

DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: L12-3E
Intendeu
Hagnos

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

{8}------------------------------------------------

DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer:

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

{9}------------------------------------------------

| System: | DC-70/DC-70T /DC-70 PRO/DC-70 EXP/DC-75/DC-78/DC-70S Diagnostic Ultrasound System |
|-------------|-----------------------------------------------------------------------------------|
| Transducer: | L14-6WE |

| Clinical Application | | | Mode of Operation | | | | | | | |
|-----------------------------|---------------------------------------------------------------------------------------------|---|-------------------|-----|-----|--------------------------|----------------------|-----------------------|--------------------|--|
| General<br>(Track 1…