M5 DIAGNOSTIC ULTRASOUND SYSTEM

K102991 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYO · Oct 22, 2010 · Radiology

Device Facts

• Record ID: K102991
• Device Name: M5 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYO · Radiology
• Decision Date: Oct 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The M5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdomen, gynecology, obstetrics, small parts (breast, testes, thyroid, etc.), pediatrics, transcranial, cardiac, peripheral vascular, urology, orthopedics, intraoperative and musculoskeletal (general and superficial) exams.

Device Story

M5 Diagnostic Ultrasound System is a mobile, software-controlled diagnostic ultrasound system; acquires and displays images in B-Mode, M-Mode, Color, PW, CW, Power, DirPower, or combined modes (e.g., B/M). Employs linear, convex, and phased array probes (2.0 MHz to 12.0 MHz). Used in clinical settings by healthcare professionals for diagnostic imaging and fluid flow analysis. System features include Tissue Harmonic Imaging, Smart3D, iScape, iBeam, Biopsy Guidance, and Free Xros M. Output displayed on system monitor for clinician interpretation to support clinical decision-making and patient diagnosis.

Clinical Evidence

Bench testing only. Evaluated for acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety. Conforms to standards: UD 2, UD 3, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4, and ISO 10993-1.

Technological Characteristics

Mobile ultrasound system; frequency range 2.0-12.0 MHz; supports linear, convex, and phased array transducers. Modes: B, M, Color, PW, CW, Power, DirPower. Standards: IEC 60601-1, IEC 60601-2-37, ISO 10993-1. Features: Tissue Harmonic Imaging, Smart3D, iScape, iBeam, Biopsy Guidance, Free Xros M. Software-controlled.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates for diagnostic ultrasound imaging or fluid flow analysis in abdominal, gynecological, obstetric, small parts (breast, testes, thyroid), pediatric, transcranial, cardiac, peripheral vascular, urological, orthopedic, intraoperative, and musculoskeletal exams.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Mindray M7 (K100830)
• Mindray M5 (K083001)
• Mindray DC-6 (K072164)

Submission Summary (Full Text)

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

# 510(K) SUMMARY

K1029 91 OCT 2 2 2010

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: May 28, 2010

#### 2. Device Name: M5 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. Marketed Device:

The subject device is substantially equivalent in its technologies and functionality to the following devices: Mindray M7(K100830), Mindray M5(K083001) and Mindray DC-6(K072164).

## 4. Device Description:

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The M5 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, CW mode, Power mode, DirPower 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.

## 5. Intended Use:

The M5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdomen, gynecology, obstetrics, small parts (breast, testes, thyroid, etc.), pediatrics, transcranial, cardiac, peripheral vascular, urology, orthopedics, intraoperative and musculoskeletal (general and superficial) exams.

#### 6. Comparison with Predicate Device:

M5 Diagnostic Ultrasound System is comparable with and substantially equivalent to the Mindray M7(K100830), Mindray M5(K083001) and Mindray DC-6(K072164). 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.

#### 7. Non-clinical Tests:

M5 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 and ISO 10993-1.

#### 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 M5 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized design featuring three curved lines that resemble a person or figure in motion.

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. % Mr. Jeff D. Rongero Senior Project Manager Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709

OCT 2 2 2010

Re: K102991

Trade/Device Name: M5 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYO, IYN, and ITX Dated: October 6, 2010 Received: October 7, 2010

Dear Mr. Rongero:

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. Iisting 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 M5 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

| 3C5s | 6LE7s | L14-6s |
|-------|-------|--------|
| 6C2s | 6LB7s | C5-2s |
| 6CV1s | 3C1s | L11-4s |
| 7L4s | 2P2s | P4-2s |
| 7L6s | 7L5s | |
| 10L4s | 7LT4s | |

{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.goy/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/ReportaProblem/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 vours.

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)

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## Indications for Use

K102991

OCT 2 2 2010

510(k) Number (if known):

Device Name:M5 Diagnostic Ultrasound System

Indications For Use:

The M5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdomen, gynecology, obstetrics small parts (breast, testes, thyroid, etc.), pediatrics, transcranial, cardiac, peripheral vascular, urology, orthopedics, intraoperative and musculoskeletal (general and superficial) exams.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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

510K

Page 1 of 1

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System:

M5 Diagnostic Uitrasound System

N/A

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 | P | P | P | P | P | P | P | Note 1,2,3,4,5,6 |
| Fetal<br>Imaging<br>& Other | Abdominal | P | P | P | P | P | P | P | Note 1,2,3,4,5,6 |
| | 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 |
| | 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 | Note 2,3,4,5,6 |
| | Trans-vaginal | 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 | Note 2,3,4,5,6 |
| | Musculo-skeletal<br>Superficial | P | P | P | | P | P | P | Note 2,3,4,5,6 |
| | Intravascular | | | | | | | | |
| | Other (specify)*** | P | P | P | | P | P | P | Note 1, 2, 3,4,5,6 |
| | 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 |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | P | P | P | | P | P | P | Note 1,2,3,4,5,6 |
| | Other | | | | | | | | |

N=new indication; P=previously cleared by FDA; E=added under Appendix E

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.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

- Note 2: Smart3D
Note 3: iScape

Note4: iBeam

NoteS: Biopsy Guidance

Note6: Free Xros M

Prescription USE (Per 21 CFR 801.109)

_
(Division Sign-Off)_

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

510K K102991

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

System:

M5 Diagnostic Ultrasound System 3C5s

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 | 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 | Neonatal Cephalic | | | | | | | | |
| Imaging | Adult Cephalic | | | | | | | | |
| & Other | 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 Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| Peripheral | Peripheral Vascular | P | P | P | | P | P | P | Note 1, 2, 3,5,6 |
| Vascular | Other | | | | | | | | |

N=new indication; P=previously cleared by FDA; E=added under Appendix E

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.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3: iScape

Note4: iBeam

510k

Note5: Biopsy Guidance

Note6: Free Xros M

Prescription USE (Per 21 CFR 801.109)

_
(Division Sign-Off)

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

2

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

MS Diagnostic Ultrasound System

System: Transducer:

6C2s

Intended Use:

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

3

| 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, 3,5,6 |
| | Intraoperative (specify)* | | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 2, 3,5,6 |
| | Small organ(specify)** | | | | | | | | |
| Fetal | Neonatal Cephalic | P | P | P | | P | P | P | Note 2, 3,5,6 |
| Imaging | Adult Cephalic | P | P | P | | P | P | P | Note 2, 3,5,6 |
| & Other | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | | |
| | Musculo-skeletal Conventional | | | | | | | | |
| | Musculo-skeletal Superfícial | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (specify)*** | P | P | P | | P | P | P | Note 2, 3,5,6 |
| | 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 |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| Peripheral | Peripheral Vascular | | | | | | | | |
| Vascular | Other | | | | | | | | |

N=new indication; P=previously cleared by FDA; E=added under Appendix E

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.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3: iScape

Note4: iBeam

510K

Note5: Biopsy Guidance

Note6: Free Xros M

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off)

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

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

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<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 | P | P | P | | P | P | P | Note2, 3,5,6 |
| | Abdominal | | | | | | | | |
| | Intraoperative (specify)* | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Intraoperative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small organ(specify) ** | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | P | P | P | P | P | P | P | Note2, 3,5,6 |
| | Trans-vaginal | P | P | P | P | P | P | P | Note2, 3,5,6 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal Conventional | | | | | | | | |
| | Musculo-skeletal Superficial | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (specify) *** | P | P | P | P | P | P | P | Note2, 3,5,6 |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| Cardiac<br>& Other | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| Peripheral<br>Vascular<br>& Other | Peripheral Vascular | | | | | | | | |
| | Other | | | | | | | | |

### Diagnostic Ultrasound Indications for Use Form M5 Diagnostic Ultrasound System

6CV1s

N=new indication; P=previously cleared by FDA; E=added under Appendix E

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

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3: iScape

Note4: iBeam

Note5: Biopsy Guidance

Note6: Free Xros M

Prescription USE (Per 21 CFR 801.109)

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

510K 15102991

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

| | 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 | | | | | | | | |
| | 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 |
| Fetal<br>Imaging<br>& Other | 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 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 |
| | Other | | | | | | | | |

M5 Diagnostic Ultrasound System

7L4s

Transducer:

System:

Intended Use:

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

N=new indication; P=previously cleared by FDA; E=added under Appendix E

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.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3 : iScape

Note4: iBeam

NoteS: Biopsy Guidance

Note6: Free Xros M

Prescription USE (Per 21 CFR 801.109)

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

510K K102991

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

M5 Diagnostic Ultrasound System

7L6s

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<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 | | | | | | | | |
| | 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 |
| Fetal | Neonatal Cephalic | P | P | P | | P | P | P | Note 2,3,4,5,6 |
| Imaging | Adult Cephalic | | | | | | | | |
| & Other | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>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 | Peripheral Vascular | P | P | P | | P | P | P | Note 2,3,4,5,6 |
| Vascular | Other | | | | | | | | |

N=new indication; P=previously cleared by FDA; E=added under Appendix E

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.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3: iScape

Note4: iBeam

Note5: Biopsy Guidance

Note6: Free Xros M

Prescription USE (Per 21 CFR 801.109)

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

510K K102991

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

M5 Diagnostic Ultrasound System

Transducer:

System:

10L4s

Intended Use:

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

7

| | 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 | | | | | | | | |
| | 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 | Adult Cephalic | | | | | | | | |
| Imaging | Trans-rectal | | | | | | | | |
| & Other | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>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 | Peripheral Vascular | P | P | P | | P | P | P | Note 2,3,4,5,6 |
| Vascular | Other | | | | | | | | |

N=new indication; P=previously cleared by FDA; E=added under Appendix E

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.

Note 1: Tissue Harmonic Imaging.The feature does not use contrast agents,

Note 2: Smart3D

Note 3: iScape

Note4: iBeam

Note5: Biopsy Guidance

Note6: Free Xros M

Prescription USE (Per 21 CFR 801.109)

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

510K K102991

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

M5 Diagnostic Ultrasound System

Transducer:

6LE7s

،

Intended Use:

System:

Diagnostic ultrasound imaging or fluid 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 | P | P | P | | P | P | P | Note 2,3,4,5,6 |
| | Abdominal | | | | | | | | |
| | Intraoperative (specify)* | | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| Fetal<br>Imaging<br>& Other | 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 Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | | | | | | | | |
| | Other | | | | | | | | |

N=new indication; P=previously cleared by FDA; E=added under Appendix E

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.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3: iScape

Note4: iBeam

Note5: Biopsy Guidance

Note6: Free Xros M

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Devices Office of Ir itro Diagnostic Device Evaluation and Sater,

510K K102991

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

| Intended Use: | | Diagnostic ultrasound imaging or fluid 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 | | | | | | | | | | |
| | Intraoperative (specify)* | | | | | | | | | | |
| | Intraoperative (Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | 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 Adult | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | |
| | Intra-Cardiac | | | | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | | | | | | | | | | |
| | Other | | | | | | | | | | |

MS Diagnostic Ultrasound System

6LB7s

System: Transducer:

N=new indication; P=previously cleared by FDA; E=added under Appendix E

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.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3: iScape

Note4: iBeam

Note5: Biopsy Guidance

Note6: Free Xros M

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Di ice Evaluation and Safety stic Dev

510K K102991

{14}------------------------------------------------

M5 Diagnostic Ultrasound System

System: Transducer:

3Cls

Intended Use:

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

10

| 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 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)*** | | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | | P | P | P | Note 1,2,3,5,6 | |
| | Cardiac Pediatric | P | P | P | | P | P | P | Note 1,2,3,5,6 | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | | |
| | Intra-Cardiac | | | | | | | | | |
| Peripheral<br>Vascular | Peripheral Vascular | | | | | | | | | |
| | Other | | | | | | | | | |

N=new indication; P=previously cleared by FDA; E=added under Appendix E

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.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

- Note 3 : iScape
Note4: iBcam

Note5: Biopsy Guidance

Note6: Free Xros M

510K

Prescription USE (Per 21 CFR 801.109)

Olivision Sian-Off Division of Radiological Devices Office of In Evaluation and Safet,

{15}------------------------------------------------

M5 Diagnostic Ultrasound System

System: Transducer:

2P2s

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

N=new indication; P=previously cleared by FDA; E=added under Appendix E

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

*I…