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 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.

AI/ML Overview

This submission is a 510(k) Pre-market Notification for the Z5 Diagnostic Ultrasound System. This document focuses on establishing substantial equivalence to existing predicate devices rather than providing a detailed study of the device's performance against specific acceptance criteria. Therefore, most of the requested information about acceptance criteria and a device performance study including sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not explicitly present in provided text.

Based on the provided information, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) for image quality or diagnostic capabilities. Instead, it relies on demonstrating substantial equivalence to predicate devices, which implies that the device's performance is expected to be comparable and safe.

The "reported device performance" is implicitly that the device is "substantially equivalent" to the predicate devices and conforms to various safety standards.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Safety	Conformity with applicable medical safety 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, ISO 10993-1, IEC 62366, IEC 62304.	"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." "The device conforms to applicable medical device safety standards."
Effectiveness/Equivalence	Same technological characteristics as predicate devices (Mindray Z6, M5, DP-30). Comparable in key safety and effectiveness features as predicate devices. Same intended uses and basic operating modes as predicate devices.	"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." "Therefore, the Z5 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market."
Quality System	Conformity with 21 CFR 820. ISO 9001 and ISO 13485 quality systems.	"The design, development and quality process of the manufacturer confirms with 21 CFR 820. ISO 9001 and ISO 13485 quality systems."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not provide any information regarding a specific clinical test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective). The submission relies on non-clinical testing and comparison to predicate devices, not on a new clinical study with a test set.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Since no clinical test set is described, there is no information provided on the number or qualifications of experts used to establish ground truth.

4. Adjudication Method:

Given the absence of a described clinical test set, there is no information provided on an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention a multi-reader, multi-case comparative effectiveness study or any effect size for human readers improving with AI assistance. The Z5 is a diagnostic ultrasound system, and the submission predates widespread AI integration in such devices for diagnostic assistance comparisons.

6. Standalone Performance Study:

The document does not describe a standalone (algorithm only without human-in-the-loop performance) study. The Z5 is a complete ultrasound system, and its performance is inherently a human-in-the-loop process.

7. Type of Ground Truth Used:

No specific ground truth (expert consensus, pathology, outcomes data, etc.) is mentioned as being used for the performance evaluation of the Z5 Diagnostic Ultrasound System. The evaluation is focused on technical standards compliance and substantial equivalence to previously cleared devices.

8. Sample Size for the Training Set:

The document does not mention a training set as it pertains to AI or machine learning algorithms. The Z5 is a traditional diagnostic ultrasound system.

9. How the Ground Truth for the Training Set was Established:

Since no training set for AI/ML is mentioned, there is no information provided on how ground truth for such a set would have been established.

In summary: The provided 510(k) summary focuses on the technical specifications, intended use, and comparison to predicate devices to establish substantial equivalence for the Z5 Diagnostic Ultrasound System. It is not a clinical study report that would typically detail performance against specific clinical acceptance criteria using patient data, expert ground truth, or statistical measures like those requested.

Summary

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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: +86 755 8188 5658 Fax: +86 755 2658 2680

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

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:

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KJ30695
Page 2 of 2

4. Intended Use:

5. Comparison with Predicate Devices:

PredicateDevice	Manufacturer	Model	510(k)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

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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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	ColorDoppler	Amplitudee 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)**	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

ーー・・・ーー・

System

।

Prescription USE (Per 21 CFR 801.109)

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

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

Clinical Application.	B	M	PWD	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

ﻟﻌﺎﻟﻤﻴﺔ ﺍﻟﻤﺴﺘﻌﻤﺪ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ

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

Prescription USE (Per 21 CFR 801.109)

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

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

Transducer

System

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

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)

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	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)

· · · · · · · · · · · · · · · · · · · · · · · · ·

・・・.

Prescription USE (Per 21 CFR 801.109)

. . . . . . . . . . . . .

{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

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.