Z5 DIAGNOSTIC ULTRASOUND SYSTEM

K130695 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Jun 19, 2013 · Radiology

Device Facts

• Record ID: K130695
• Device Name: Z5 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Jun 19, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The Z5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric and neonates. It is intended for use in Fetal, Abdominal, Pediatric, Musculo-skeletal (conventional, superficial), Peripheral Vascular, Trans-vaginal, Small organ (breast, thyroid and testes), Cephalic (neonatal and adult), Cardiac (adult and pediatric) and Urology exams.

Device Story

Z5 is a mobile, software-controlled diagnostic ultrasound system; acquires and displays ultrasound data in B, M, PW, Color, Power, HPRF, iScape, or combined modes (e.g., B/M, B/PW, B/PW/Color). System utilizes linear and convex array probes (3.5 MHz to 10.0 MHz). Operated by clinicians in clinical settings to perform diagnostic imaging. Output displayed on system monitor for real-time visualization; assists healthcare providers in clinical decision-making for fetal, abdominal, cardiac, and other specified exams. Benefits include non-invasive diagnostic imaging for various patient populations.

Clinical Evidence

Bench testing only. Evaluated for acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety. Conforms to standards including UD 2, UD 3, IEC 60601-1 series, IEC 60601-2-37, UL 60601-1, ISO 14971, ISO 10993-1, IEC 62366, and IEC 62304.

Technological Characteristics

Mobile ultrasound system; linear and convex array transducers (3.5-10.0 MHz). Modes: B, M, PW, Color, Power, HPRF, iScape, Tissue Harmonic Imaging, Smart3D, 4D, TDI, Color M, Biopsy Guidance. Standards: IEC 60601-1, IEC 60601-2-37, ISO 10993-1, ISO 14971, IEC 62304. Software-controlled.

Indications for Use

Indicated for adults, pregnant women, pediatric, and neonates for fetal, abdominal, pediatric, musculoskeletal, peripheral vascular, trans-vaginal, small organ, cephalic, cardiac, and urology ultrasound 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

• Mindray Z6 (K122010)
• Mindray M5 (K102991)
• Mindray DP-30 (K113153)

Submission Summary (Full Text)

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page 1 of 2

# 510(K) SUMMARY

JUN 1 9 2013

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:

Wu Zicui 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: November 12, 2012

2. Device Name: Z5 Diagnostic Ultrasound System

#### Classification

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

### 3. Device Description:

Z5 is a mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B, M, PW, Color, Power, HPRF, iScape, or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color).This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 3.5 MHz to 10.0 MHz.

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KJ30695
Page 2 of 2

# 4. Intended Use:

The Z5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric and neonates. It is intended for use in Fetal, Abdominal, Pediatric, Musculo-skeletal (conventional, superficial), Peripheral Vascular, Trans-vaginal, Small organ (breast, thyroid and testes), Cephalic (neonatal and adult), Cardiac (adult and pediatric) and Urology exams.

#### 5. Comparison with Predicate Devices:

| Predicate<br>Device | Manufacturer | Model | 510(k)<br>Number |
|---------------------|--------------|-------|------------------|
| 1 | Mindray | Z6 | K122010 |
| 2 | Mindray | M5 | K102991 |
| 3 | Mindray | DP-30 | K113153 |

Z.5 Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

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 devices.

#### 6. Non-clinical Tests:

Z.5 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 60601-1-4, IEC 60601-2-37, UL 60601-1, ISO14971 and ISO 10993-1, IEC 62366, 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 Z5 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

June 19, 2013

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

Shenshen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Jeff D. Rongero Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive RESEARCH TRIANGLE PARK NC 27709

Re: K130695

Trade/Device Name: Z5 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: May 30, 2013 Received: June 11, 2013

Dear Mr. Rongero:

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.

This determination of substantial equivalence applies to the following transducers intended for use with the Z5 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

35C50EA 65EC10EA 75L38EA 65C15EA 35C20EA 10L24EA

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

Page 2-Mr. Rongero

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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

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

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

-Sincerely-vours.

Sm. 7.)

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K130695

Device Name: The Z5 Diagnostic Ultrasound System

Indications for Use:

The Z5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric and neonates. It is intended for use in Fetal, Abdominal, Pediatric, Musculoskeletal (conventional, superficial), Peripheral Vascular, Trans-rectal, Trans-vaginal, Small organ (breast, thyroid and testes), Cephalic (neonatal and adult), Cardiac (adult and pediatric) and Urology exams.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

> K130695 510(k)

> > Page 1 of 8

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| Model: | Z5 | | | | | | | |
|---------------------------------------------------------------------------------------------------|---------|---|-----|-----|------------------|------------------------|-----------------------|-----------------|
| 510(k) Number(s) | K130695 | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>e Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | N | N | N | | N | N | N | Note 1,4,7 |
| Abdominal | N | N | N | | N | N | N | Note 1,4,7 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | N | N | N | | N | N | N | Note 1,4,7 |
| Small organ(specify)** | N | N | N | | N | N | N | Note 1, 4,7 |
| Neonatal Cephalic | N | N | N | | N | N | N | Note 1,4,7 |
| Adult Cephalic | N | N | N | | N | N | N | Note 1,4,7 |
| Trans-rectal | N | N | N | | N | N | N | Note 1,4,7 |
| Trans-vaginal | N | N | N | | N | N | N | Note 1,4,7 |
| Trans-urethral | | | | | | | | |
| Trans-esoph (non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | N | N | N | | N | N | N | Note 1,4,7 |
| Musculo-skeletal Superficial | N | N | N | | N | N | N | Note 1,4,7 |
| Intravascular | | | | | | | | |
| Cardiac Adult | N | N | N | | N | N | N | Note 1,4,7 |
| Cardiac Pediatric | N | N | N | | N | N | N | Note 1,4,7 |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | N | N | N | | N | N | N | Note 1,4,7 |
| Other (specify)*** | N | N | N | | N | N | N | Note 1,4;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 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: 4D(Real-time 3D) | | | | | | | | |
| Note 4: iScape | | | | | | | | |
| Notes: TDI | | | | | | | | |
| Note6: Color M | | | | | | | | |
| Note7: Biopsy Guidance | | | | | | | | |

# Diagnostic Ultrasound Indications for Use Form

Transducer

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×

System

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Prescription USE (Per 21 CFR 801.109)

.

:

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

| System | | | 35C50EA | Transducer | X |
|------------------|--|--|---------|------------|---|
| Model: | | | | | |
| 510(k) Number(s) | | | K130695 | | |

| Clinical Application. | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
|-------------------------------|---|---|-----|-----|---------------|-------------------|--------------------|-----------------|
| Ophthalmic | | | | | | | | |
| Fetal | N | N | N | | N | N | N | Note 1, 4,7 |
| Abdominal | N | N | N | | N | N | N | Note 1, 4,7 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | N | N | N | | N | N | N | Note 1, 4,7 |
| Small organ(specify)** | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | N | N | N | | N | N | N | Note 1, 4,7 |
| Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | N | N | N | | N | N | N | Note 1, 4,7 |
| Other (specify)*** | | | | | | | | |

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 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 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

,

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・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

Prescription USE (Per 21 CFR 801.109)

:

.

.

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

| Diagnostic Ultrasound Indications for Use Form |
|------------------------------------------------|
|------------------------------------------------|

Transducer

-

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

×

System

l

.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. .

6SEC10EA

K130695

Model: 510(k) Number(s)

| | Mode of Operation | | | | | | | |
|-------------------------------|-------------------|---|-----|-----|---------------|-------------------|--------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | N | N | N | | N | N | N | Note 1, 4,7 |
| Abdominal | | | | | | | | |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | | | | | | | | |
| Small organ(specify)** | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | N | N | N | | N | N | N | Note 1, 4,7 |
| Trans-vaginal | N | N | N | | N | N | N | Note 1, 4,7 |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph.(Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Other (specify)*** | N | N | N | | N | N | N | Note 1,4,7 |

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 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 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription USE (Per 21 CFR 801.109)

·

.

.

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

#### Diagnostic Ultrasound Indications for Use Form Transducer

751,38EA

K 130692

×

System

Model: 510(k) Number(s)

Mode of Operation Clinical Application Color Amplitud Combined B M PWD CWD Other (specify) Doppler e Doppler (specify) Ophthalmic Fetal Abdominal N N N N N Note 1,4,7 N Intraoperative (specify)* Intraoperative (Neuro) Laparoscopic Pediatric N N N N N N Note 1,4,7 N Small organ(specify)** N N N N N Note 1,4,7 Neonatal Cephalic N N N N N N Note 1,4,7 Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skeletal Conventional N N N N N N Note 1,4,7 Musculo-skeletal Superficial N N N N N N Note 1.4.7 Intravascular Cardiac Adult Cardiac Pediatric Intravascular (Cardiac) Trans-esoph.(Cardiac) Intra-Cardiac Peripheral-Vascular--N--N--N--N--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------N--Note-1-4-7-Other (specify) ** * 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 3:4D(Real-time 3D) Note 4: iScape

Note5 TDI Note6: Color M

Note7: Biopsy Guidance

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription USE (Per 21 CFR 801.109)

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

| System | | Transducer | X |
|------------------|---------|------------|---|
| Model: | 65C15EA | | |
| 510(k) Number(s) | K130695 | | |

| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
|-------------------------------|---|---|-----|-----|---------------|-------------------|--------------------|-----------------|
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | N | N | N | | N | N | N | Note 1,4,7 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | N | N | N | | N | N | N | Note 1,4,7 |
| Small organ(specify)** | | | | | | | | |
| Neonatal Cephalic | N | N | N | | N | N | N | Note 1,4,7 |
| Adult Cephalic | N | N | N | | N | N | N | Note 1,4,7 |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph.(Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Other (specify)*** | | | | | | | | |

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 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 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Diagnostic Ultrasound Indications for Use Form

Prescription USE (Per 21 CFR 801.109)

: . ·

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

| System | | | | Transducer | X |
|------------------|---------|--|--|------------|---|
| Model: | 35C20EA | | | | |
| 510(k) Number(s) | K130695 | | | | |

| | Mode of Operation | | | | | | | |
|-------------------------------|-------------------|---|-----|-----|---------------|-------------------|--------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | N | N | N | | N | N | N | Note 1,4,7 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | N | N | N | | N | N | N | Note 1,4,7 |
| Small organ(specify)** | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | |
| Intravascular | | | | | | | | |
| Cardiac Adult | N | N | N | | N | N | N | Note 1,4,7 |
| Cardiac Pediatric | N | N | N | | N | N | N | Note 1,4,7 |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Other (specify)*** | | | | | | | | |

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 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: 4D(Real-time 3D)

Note 4: iScape

Notes: TDI

Note6: Color M

Note7: Biopsy Guidance

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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・・・.

Prescription USE (Per 21 CFR 801.109)

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

| System Model: | 101.24EA |
|------------------|----------|
| 510(k) Number(s) | K130695 |
| Transducer | X |

| Clinical Application | Mode of Operation | | | | | | | |
|-------------------------------|-------------------|---|-----|-----|---------------|-------------------|--------------------|-----------------|
| | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | Other (specify) |
| Ophthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | N | N | N | | N | N | N | Note 1,4,7 |
| Intraoperative (specify)* | | | | | | | | |
| Intraoperative (Neuro) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | N | N | N | | N | N | N | Note 1,4,7 |
| Small organ(specify)** | N | N | N | | N | N | N | Note 1,4,7 |
| Neonatal Cephalic | N | N | N | | N | N | N | Note 1,4,7 |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | | |
| Trans-vaginal | | | | | | | | |
| Trans-urethral | | | | | | | | |
| Trans-esoph.(non-Card.) | | | | | | | | |
| Musculo-skeletal Conventional | N | N | N | | N | N | N | Note 1,4,7 |
| Musculo-skeletal Superficial | N | N | N | | N | N | N | Note 1,4,7 |
| Intravascular | | | | | | | | |
| Cardiac Adult | | | | | | | | |
| Cardiac Pediatric | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | |
| Trans-esoph (Cardiac) | | | | | | | | |
| Intra-Cardiac | | | | | | | | |
| Peripheral Vascular | N | N | N | | N | N | N | Note 1 4,7 |
| Other (specify) *** | | | | | | | | |

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 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 3:4D(Real-time 3D) |
|-----------------|-------------------------|
| Note 4: iScape | Note5: TDI |
| Note6: Color M | Note7: Biopsy Guidance |

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription USE (Per 21 CFR 801.109)

# Diagnostic Ultrasound Indications for Use Form

\$\left(m:7\right)\$

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

> 510(k) K130695