DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM

K102865 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · ITX · Nov 3, 2010 · Radiology

Device Facts

• Record ID: K102865
• Device Name: DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: ITX · Radiology
• Decision Date: Nov 3, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The DC-3/DC-3T diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetrics, abdominal, pediatric, small parts(breast, thyroid, testicle, etc), neonatal cephalic, transcranial, cardiac, transrectal,peripheral vascular, intraoperative, urology, orthopedics, and musculoskeletal (conventional and superficial) exams.

Device Story

DC-3/DC-3T is a mobile, software-controlled diagnostic ultrasound system. It utilizes linear, convex, and phased array probes (2.0-12.0 MHz) to acquire and display images in B-Mode, M-Mode, Color Doppler, PW Doppler, and Power Doppler, including combined modes (e.g., B/M). Used in clinical settings by healthcare professionals for diagnostic imaging and fluid flow analysis. The system processes ultrasound signals to generate real-time images, aiding clinicians in anatomical visualization and clinical decision-making across various specialties. Benefits include non-invasive diagnostic assessment of internal structures and blood flow.

Clinical Evidence

Bench testing only. The device was evaluated for acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety. It conforms to standards including IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, and IEC 62304.

Technological Characteristics

Mobile ultrasound system; array probes (linear, convex, phased); frequency range 2.0-12.0 MHz. Operating modes: B, M, PW, Color, Power, and combined modes. Software-controlled. Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and IEC 62304. Biocompatible materials per ISO 10993-1.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates for diagnostic ultrasound imaging or fluid flow analysis in gynecology, obstetrics, abdominal, pediatric, small parts (breast, thyroid, testicle), neonatal cephalic, transcranial, cardiac, transrectal, peripheral vascular, intraoperative, urology, orthopedics, and musculoskeletal exams.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

• Mindray DC-7 (K101041)
• Mindray DC-3/DC-3T (K091941)
• Mindray M5 (K102991)

Submission Summary (Full Text)

{0}------------------------------------------------

NOV -

# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92(c).

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

## 1. Submitter:

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building. Keji 12th Road South, Hi-tech Industrial Park, Nanshan. Shenzhen, 518057. P. R. China

Tel: [phone] Fax: [phone]

### Contact Person:

Zhai Pei Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Date Prepared: September 27, 2010

## 2. Device Name:

DC-7 Diagnostic Ultrasound System DC-3/DC-3T Diagnostic Ultrasound System

## Classification

Regulatory Class: II Review Category: Tier II 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-IYN) 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-1YO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

## 3. Device Description:

The DC-3/DC-31 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, Color mode, PW mode, PW mode, Power mode, DirPower

{1}------------------------------------------------

mode or the combined mode (i.e. B/M Mode). This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 2.0 MHz to 12.0 MHz.

## 4. Intended Use:

The DC-3/DC-3T diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetrics, abdominal, pediatric, small parts(breast, thyroid, testicle, etc), neonatal cephalic, transcranial, cardiac, transrectal,peripheral vascular, intraoperative, urology, orthopedics, and musculoskeletal (conventional and superficial) exams.

## 5. Comparison with Predicate Device:

DC-3/DC-3T Diagnostic Ultrasound System is comparable with and substantially equivalent to the Mindray DC-7(K101041), Mindray DC-3/DC-3T (K091941) and Mindray M5(K102991) Diagnostic Ultrasound System. They have the same technological characteristics. are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate device.

## 6. Non-clinical Tests:

DC-3/DC-3T Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical safety standards. This device has been designed to meet the following standards: UD 2, UD 3.IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37 ,IEC 60601-1-4 ,ISO 10993-1 and IEC 62304.

## Conclusion:

Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the DC-3/DC-37 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

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

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Ms. Susan D. Goldstein-Falk Official Correspondent mdi Consultants, Inc. 55 Northern Blvd., Suite 200 GREAT NECK NY 11021

NOV - 3 2010

Re: K102865

Trade/Device Name: DC-3/DC-3T Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN, and ITX Dated: September 30, 2010 Received: September 30, 2010

Dear Ms. Goldstein-Falk:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the DC-3/DC-3T Diagnostic Ultrasound System, as described in your premarket notification:

#### Transducer Model Number

| 3C5A | 6C2 | 7L5 |
|------|------|------|
| 6CV1 | 6LE7 | 7LT4 |
| 7L4A | 6LB7 | D6-2 |
| 7L6 | 3C1 | |
| 10L4 | 2P2 | |

{3}------------------------------------------------

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Paul Hardy at [phone].

Sincerely yours,

Signature

David G. Brown. Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

{4}------------------------------------------------

| | | | | : | | . | ी | | : | | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|----------------------------------|---------------------|------------------------------------------------------------|---------------------|---|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|--|
| | | | | | | | | | | | | | | | |
| | | | | | | | | : | | | | : | | | |
| | | | : | | | | . | | : | : | : | | | | |
| | | | | : 浏 | ് | ,那个 | | Indications for Use | | | : | NOV - | 3 2010 | | |
| | | | - This | 料 | 1000 | 100 | :: : | | | | ্রি বাংলাদেশ বিশ্ব | ు ప్రస | | | |
| :::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: | | | 510(k) Number (if known): | | | | : | | | ・・ | 中文 | : 湖 | ಿಗಳು ಸಾಮಾನ | | |
| | | | | | | | Device Name: DC-3/DC-3T Diagnostic Ultrasound System | | | | | | | | |
| | | | Indications For Use: | | | -------- | : | | | :: | | ं क | : : | | |
| | | | | | | | | | | The DC-31DC-31 diagnostic ultrasound system is applicable for adults, progrant women, pediatric patients and neonates. It is intended for use in gynecology, obsterics, abdomi | | | | | |
| | | | | | | | | | | transcranial, cardiac, transvaginal, transrectal, peripheral vascular, intraoperative, urology, orthopedics, and musculoskeletal (conventional and superficial) exams | | | | | |
| | | | | | ్రా | | | | | | ﻢ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ | | | | |
| | | | | | ે. વિસ્ત | | | | | | | | ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ | 11:22 | |
| | | ું તુર્મ | xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx | . | | | | | | | | | | | |
| | | : | :<br>Prescription Use | | | | | AND/OR | | Over-The-Counter Use | | | | | |
| | . | | (Part 21 CFR 801 Subpart D) | | | | | | | (21 CFR 807 Subpart C) | | | : | | |
| | | | | | | | | | | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF | | | | | |
| | . | | NEEDED) | | 1 1882 | . Parti | | | | | | | | . : : # | |
| | | | | | | | | | | Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) | | | | | |
| | | | | | 人都 | | | | | | | 197 | | | |
| | | | | : | | | | | | | | | | | |
| | | 100 | | | Division of Radiological Devices | (Division Sign-Off) | Office of In Vitro Diagnostic Device Evaluation and Safety | | | | | : | - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - | | |
| | | | | રાજ્ય | ਸੰਸ ਨੇ ਕ | 103 8 | | | | | | | | | |
| | | | | | . | | . | 18 80 | | | | | 2017 | | |

:

:

-

{5}------------------------------------------------

#### Dlagnostic Ultrasound Indications for Use Form

#### DC-3/DC-3T Dingnostie Ultrasound System nia

Transcucer: Intendod Use;

Sustern:

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

| | Mode of Operation | | | | | | | | |
|-----------------------------|----------------------------------|---|-----|-----|---------------|-------------------|--------------------|--------------------|--------------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) | |
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | | | | | | | | |
| Ophthalmic | Ophthalmic | P | P | P | P | P | P | Note 1,2,3,4,5,6,7 | |
| Fetal<br>Imaging<br>& Other | Fetal | P | P | P | P | P | P | P | Note 1,2,3,4,5,6,7 |
| | Abdominal | P | P | P | P | P | P | P | Note 1,2,3,4,5,6,7 |
| | Intraoperative (specify)* | P | P | P | P | P | P | P | Note 2,3,4,5,6 |
| | Intraoperative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P | Note 1,2,3,4,5,6,7 |
| | Small organ(specify)** | P | P | P | P | P | P | P | Note 2,3,4,5,6 |
| | Neonatal Cephalic | P | P | P | P | P | P | P | Note 1,2,3,4,5,6 |
| | Adult Cephalic | P | P | P | P | P | P | P | Note 1,2,3,5,6 |
| | Trans-rectal | P | P | P | P | P | P | P | Note 2,3,4,5,6 |
| | Trans-vaginal | P | P | P | P | P | P | P | Note 2,3,5,6 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>Conventional | P | P | P | P | P | P | P | Note 2,3,4,5,6 |
| | Musculo-skeletal<br>Superficial | P | P | P | P | P | P | P | Note 2,3,4,5,6 |
| | Intravascular | | | | | | | | |
| | Other (specify)*** | P | P | P | P | P | P | P | Note 1,2,3,4,5,6 |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P | Note 1,2,3,4,5,6 |
| | Cardiac Pediatric | P | P | P | P | P | P | P | Note 1,2,3,4,5,6 |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | P | P | P | P | P | P | P | Note 1,2,3,4,5,6 |
| | Other (specify) | | | | | | | | |

new indication; Papreviously cizared by FDA; E=added under Appendix E

Addisonal comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + P.W +B.

- ·Intraoperative includes abdominal, theracic, and vascular etc.
- * Small organ-breast, thyroid, testes, etc.
- ** *Other use includes Urology. Note I: Tizsue Harmonie Imaging.
- Note 2; SmarlJD
- Note 3: iScape
- Noter: iBeam
- Notes: Biopsy Quidar

Notes: Frec Xros M

Note?: 4D

STOK

Prescription USE (Per 2

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

0030

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

## Diagnostic Ultrasound Indications for Use Form

System: Transduccr:

DC-3/DC-3T Diagnostic Ultrasound System 3C5A

Intended Use:

Diagnostic altrasound imaging or fluid flow analysis of the turnan body as follows:

| | Clinical Application | | Mode of Operation | | | | | | | |
|------------------------------|-------------------------------|---|-------------------|-----|-----|------------------|----------------------|-----------------------|------------------|--|
| General<br>(Track 1 Only) | Specific<br>(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, 3,5,6 | |
| | Abdominal | P | P | P | | P | P | P | Note 1, 2, 3,5,6 | |
| | Intraoperative (specify)* | | | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2,3,5,6 | |
| | 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 | | | | | | | | | |
| | Musculo-skeletal Superficial | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (specify)*** | P | P | P | | P | P | P | Note 1,2,3,5,6 | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | | |
| | Intra-Cardiac | | | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | P | P | P | | P | P | P | Note 1, 2, 3,5,6 | |
| | Other (specify) | | | | | | | | | |

Additional compens: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Pow

* Intraoperative includes abdominal, thorneie, sod vascular etc.

** Small organ-breast, thyroid, testes, etc.

***Other use includes Urology.

Note I: Tissue Harmonic Imaging,

રાજ્યન

Note 2: Smart3D

Note 3: Scape

Note4: iBeam Notes: Blopsy Guidance -

Note6: Free Xros M

Note7: 4D

Prescription USE (Per 21 CFR 801.109)

.

(Division Sign-Off) Division of Radiological Devices of In Vitro Diagnostic Device Evaluation and Safety

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

Mindray Co. Lt.

System : Transducer:

ndray Co. Ltd. - DC-3/DC-37 Diagnostic Ultrasound Sy

#### Diagnostic Ultrasound Indications for Use Form

DC-3/DC-3T Diagnostic Ultrasound System ୧୯୬ ।

Diagnostic uttensound Imaging or thaid flow analysis of the human body as follows: Intended Use: : - : : Clinical Application Mode of Operation General Specific Color Amplitude Combined (Track I B ਮ PWD CWD Other (specify) Doppler (Track 1 & 3) Doppler (specify) Only) Ophibalmic Opathalmic Nore2. 3,5,5 િત્તમાં ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ ું નવ P મુજ P P P Abdominal Introperative (specify)" Intraoperative (Neuro) :55 Leparoscopic Pediatric Small organ(specify) ** Neonaral Cephalic Fetal Imaging Adult Cephalic & Other Trans-rectal P P ・ト P P ಕ್ಕಿ Note2, 3,5,6 Trans-vaginal P P P P p ﻬﺎ Note2, 3,5,6 Trans-cretheal Trans-esoph (non-Card.) ... 1 ... Musculo-skeletal Conventional : Musculo-skeletal Superficial futravascular : : Other (specify) *** p P P P P 产 Note 2,3,5,6 Cardiac Adult Cardiac Pediatric Cardiac Intravascular (Cardiac) Trans-esoph (Cardiac) Intra-Cardiac 13:40 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 Peripheral Vascular ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ Peripheral ﺔ ﺍﻟﻤﺘﺤﺪﺓ Vascular Other (specify)

Nenew indication: Pepreviously cleared by FDA: E-added under Appendix E

Additional comments: Combined mades: B+M, PW+B, Calar + B, Power + B, PW +Color+ B, Power + PW +B,

* lotraoperative includes abdominal, thoracic, and vascular etc.

** Small organ-breast, thyroid, testes, etc.

** Small organ-breast, thyroid, testes, exc.

*** Other use includes Urology.

Nate 1: Tissue Harmonic Imaging. Note 2: Smart 3D

Note 3: IScape

Note4: Besm

Notes: Blogsy Guldance

Note6: Free Xros M

Hote7: 4D

Prescription USE (Per 21 CFR 801.109)

.

(Division Sign-Off) Division of Radiological Devices Vitro Diagnostic Device Evaluation and Safety Office of In

510K K102865

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

#### Diagnostic Ultrasound Indications for Use Form

#### System: DC-3/DC-3T Diagnostic Ultrasound System 7L4A Transducer: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: 1. 1. 11.11.10.2 ... Clinical Application Mode of Operation General Spécific Color Amplitude Combined (Track I B PWD CWD Other (specify) ಹ (Track 1 & 3) Doppler Doppler (specify) Only) Ophthalmic - Ophthalmic Ophihalmic Fetal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Abdominal P p P Note 2,3,4,5,6 Intraoperative (specify)* Intraoperative (Neuro) Laparoscopic . Pediatric P P P Note 2,3,4,5,6 P P P Small organ(specify) ** P a . P . P P Note 2,3,4,5,6 Fetal Neonatal Cephalic) Ne p P P p Note 2,3,4,5,6 P Imaging Adult Cephalic ...... & Other Trans-rectal . Frans-vaginal Trans-urethral Trans csoph (non-Card.) Musculo-skeletal Conventional p P Note 2,3,4,5,6 P P p - -P Musculo-skeletal Superficial P P P P P p | | || Note 2,3,4,5,6 Intravascular ....... Other (specify) *** Cardiac Adult Cardiac Pediatric Cardiac Intravascular (Cardiac) Trans-esoph. (Cardiac) Intra-Cardiac Cardiac Section . : 发出 Peripheral Peripheral Vascular P P p P : Note 2,3,4,5,6 12 Vascular Other (specify)

Nanew indication; Pepreviously 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 etc.

** Small organ-breast, thyroid, testes, etc.

*** Other use includes Urology.

Note 1: Tissue Harmonic Imaging.

Note 2: Smart3D

Note 3: iScape

Noted: IBeam

Notes: Biopsy Guidance

Note6: Free Xros M

Note7: 4D

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

K102865

0033

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

71:6

## Diagnostic Ultrasound Indications for Use Form

DC-3/DC-3T Diagnostic Ultrasound System

System: Transducer. Intended Use:

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

| Clinical Application | | Mode of Operation | | | | | | | |
|------------------------------|-------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| General<br>(Track 1<br>Only) | Specific<br>(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 2,3,4,5,6 |
| | Intraoperative (specify)* | | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | P | P | P | | P | P | P | Note 2,3,4,5,6 |
| | Small organ(specify)** | P | P | P | | P | P | P | Note 2,3,4,5,6 |
| | Neonatal Cephalic | P | P | P | | P | P | P | Note 2,3,4,5,6 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | | |
| | Musculo-skeletal Conventional | P | P | P | | P | P | P | Note 2,3,4,5,6 |
| | Musculo-skeletal Superficial | P | P | P | | P | P | P | Note 2,3,4,5,6 |
| | Intravascular | | | | | | | | |
| | Other (specify)*** | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | P | P | P | | P | P | P | Note 2,3,4,5,6 |
| | Other (specify) | | | | | | | | |

18 12 12 12 12 12 12 12 12

*Intraoperative includes abdominal, thoracic, and vascular etc.

** Small organ-breast, thyroid, lestes, etc.

*** Qther use includes Urology.

Note I: Tissue Harmonic Imaging.

Note 2: Smart3D

Note 3: iScape

Note4: iBeam

Note5: Biopsy Guidance

Note6: Free Xros M

Note7: 4D'

રાજ્યન

Prescription USE (Per 21 CFR 801 109)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

0034

{10}------------------------------------------------

#### Diagnostic Ultrasound Indications for Use Form

IOLA

- System: Transducer:
Intended Use:

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

| Clinical Application | | | Mode of Operation | | | | | | | |
|-----------------------------|-------------------------------|--|-------------------|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| General<br>(Track 1 Only) | Specific<br>(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 2,3,4,5,6 |
| | Intraoperative (specify)* | | | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | P | P | P | | P | P | P | Note 2,3,4,5,6 |
| | Small organ(specify)** | | P | P | P | | P | P | P | Note 2,3,4,5,6 |
| | Neonatal Cephalic | | P | P | P | | P | P | P | Note 2,3,4,5,6 |
| Fetal<br>Imaging<br>& Other | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | | | |
| | Musculo-skeletal Conventional | | P | P | P | | P | P | P | Note 2,3,4,5,6 |
| | Musculo-skeletal Superficial | | P | P | P | | P | P | P | Note 2,3,4,5,6 |
| | Intravascular | | | | | | | | | |
| | Other (specify)*** | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | | |
| | Intra-Cardiac | | | | | | | | | |
| | | | | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | | P | P | P | | P | P | P | Note 2,3,4,5,6 |
| Vascular | Other (specify) | | | | | | | | | |

under Appendix E A cleared of the C.

Additional comments: Combined modes: B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW+B.

* Intraoperative includes abdominal, thoracic, and vascular etc.

** Small organ-breast, thyroid, testes, etc. ** · Other use includes Urology.

610H

ther than anhydrous C(ClO4)4.

Note 1: Tissue Harmonic Imaging. Note 2: Smart3D

- Note 3: iScape
- -Note4: iBeam

NoteS: Biopsy Guidance

Nate6: Free Xros M

- Note7: 4D
Presenption USE (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

DC-3/DC-3T Disgnostic Ultrasound System

{11}------------------------------------------------

6C2

## Diagnostic Ultrasound Indications for Use Form

DC-3/DC-3T Diagnostic Ultrasound System

System: Transducer; Intended Use:

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

| Clinical Application | | Mode of Operation | | | | | | | Other (specify) |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| General<br>(Track I Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | Note 2, 3,5,6 |
| | Intraoperative (specify)* | | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 2, 3,5,6 |
| | Small organ(specify)** | | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | P | P | Note 2, 3,5,6 |
| | Adult Cephalic | P | P | P | | P | P | P | Note 2, 3,5,6 |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | | |
| | Musculo-skeletal Conventional | | | | | | | | |
| | Musculo-skeletal Superficial | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (specify)*** | P | P | P | | P | P | P | Note 2, 3,5,6 |
| Cardiac | Cardiac Adult | P | P | P | | P | P | P | Note 2, 3,5,6 |
| | Cardiac Pediatric | P | P | P | | P | P | P | Note 2, 3,5,6 |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | | | | | | | | |
| | Other (specify) | | | | | | | | |

Nenew indication; Pepreviously cleared by FDA; E=added under Appendix E

Addlikanal comments: Combined modes: 8+M, PW+B, Color + B, Power + B, PW +Color+B, Power + PW +B

* Intraoperative includes stidominal, thoracic, and vascular etc.

- ** Small organ-breast, thyroid, testes, etc. *** Other use includes Urology.
- Note 1: Tissue Harmonic Imaging.
- Note 2: Smart3D
- Note 3: iScape
- Note4: IBeam
- Notes: Biopsy Guidance Noteb: Free Xros M
- Note7: 4D

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Dieggaesia Dai

Office of In Vitro Diagnostic Device Evaluation and Safety

iption USE (Per 21 CFR 801.109

{12}------------------------------------------------

DC-3T Diagnostic Ultrasound System

### Diagnostic Ultrasound Indications for Use Form

.

System: Transducer: DC-3/DC-3T Diagnostic Ultrasound System 6LE7

Intended Use:

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

| Clinical Application | Mode of Operation | | | | | | | | |
|------------------------------|-------------------------------|---|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| General<br>(Track 1<br>Only) | Specific<br>(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 2,3,4,5,6 |
| | Abdominal | | | | | | | | |
| | Intraoperative (specify)* | | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small organ(specify)** | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | P | Note 2,3,4,5,6 |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | | |
| | Musculo-skeletal Conventional | | | | | | | | |
| | Musculo-skeletal Superficial | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (specify)*** | P | P | P | | P | P | P | Note 2,3,4,5,6 |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | | | | | | | | |
| | Other (specify) | | | | | | | | |

Nenew 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 etc.

- **Small organ-breast, thyroid, testes, etc.**

***Other use includes Urology. Note 1; Tissue Harmonic Imaging.

Note 2: Smart3D

Note 3: iScape

Note4: iBeam

Note7: 4D

Note5: Biopsy Guidance

Note6: Free Xros M

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K102865

(Division Sign-Off)
Division of Radiological Devices

Prescription USE (Per 21 CFR

{13}------------------------------------------------

## 3-3T Diagnostic Ultrasound System

## Diagnostic Ultrasound Indications for Use Form

DC-3/DC-3T Diegnostic Ultrasound System

- System: Transducer:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use: : :
1. 2 .. 1 :

&&&

| Clinical Application | | Mode of Operation | | | | | | | |
|------------------------------|-------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| General<br>(Track 1<br>Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intraoperative (specify)* | | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small organ(specify)** | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | P | Note 2,3,4,5,6 |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph (non-Card.) | | | | | | | | |
| | Musculo-skeletal Conventional | | | | | | | | |
| | Musculo-skeletal Superficial | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (specify)*** | P | P | P | | P | P | P | Note 2,3,4,5,6 |
| | Cardiac Adult | | | | | | | |…