The DC-7 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdominal, cardiac, small organ (breast, testes, thyroid, etc.), peripheral vascular, fetal, transvaginal, pediatric, nconatal cephalic, musculoskcletal(conventional and superficial), intraoperative and transcranial exams.

Device Description

The DC-7 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, Color mode, Color M mode, PW mode, CW mode, Power/DirPower mode, TDI 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 probe, convex array probe, phased array probe and volume probe with a frequency range of approximately 1.8 MHz to 12.0 MHz.

AI/ML Overview

The provided text is a 510(k) summary for the Mindray DC-7 Diagnostic Ultrasound System. This document focuses on establishing substantial equivalence to existing devices and details the device's features, intended use, and safety considerations. It does not contain information about specific "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of performance metrics like sensitivity, specificity, or accuracy for diagnostic tasks.

Instead, the document primarily addresses:

Manufacturing and Safety Standards: The device conforms to acoustic output standards (NEMA UD 2:2004, NEMA UD 3:2004) and medical device safety standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4, and ISO 10993-1). These are the "acceptance criteria" for the safety and basic functionality of the ultrasound system itself, not for a specific diagnostic performance.
Substantial Equivalence: The primary "proof" of meeting acceptance criteria for market clearance is the demonstration that the DC-7 is "as safe and effective as the legally marketed predicate devices" (Mindray DC-7 (K#092691), Mindray DC-3 (K#091941), GE Logiq PS (K#060993), GE Voluson 730 (K#041688)). This is not a study measuring diagnostic accuracy but rather a comparison of technical characteristics and intended uses.

Therefore, many of the requested details about a performance study are not present in this type of regulatory submission. I will answer the questions based on the information available and explicitly state when information is not provided.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for an ultrasound system and not a specific diagnostic algorithm or AI, the "acceptance criteria" are related to safety, electrical, and acoustic performance, and functional equivalence to predicate devices, rather than diagnostic accuracy metrics. The document states that the device was tested to meet recognized international and national standards.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance
Safety and Effectiveness	Substantially equivalent to legally marketed predicate devices.	"The conclusions drawn from testing of the DC-7 Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices." This is a general claim based on the entire submission, including comparisons of various characteristics (technical characteristics, new features/algorithms, and indications for use) to predicate devices. The listed predicate devices are: Mindray DC-7 (K#092691), Mindray DC-3 (K#091941), GE Logiq PS (K#060993), GE Voluson 730 (K#041688).
Acoustic Output	Conforms to FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (September 2008), NEMA UD 2:2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, and NEMA UD 3:2004 Standards for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment.	"The acoustic output is measured and calculated per NEMA UD 2: 2004 (...) and NEMA UD 3: 2004 (...). The device conforms to applicable medical device safety standards..."
Medical Device Safety	Conforms to applicable medical device safety standards.	"The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4 and ISO 10993-1."
Functional Equivalence/Modes	The device should be capable of acquiring and displaying ultrasound images in specified modes (B-mode, M-mode, Color mode, Color M mode, PW mode, CW mode, Power/DirPower mode, TDI mode, combined modes) and for the stated clinical applications with the listed transducers.	The comprehensive "Indications for Use" forms for the system and each transducer (pages 5-23 of the original document) list the specific modes of operation (B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined) and clinical applications (e.g., Fetal, Abdominal, Cardiac, Small organ, Peripheral Vascular, etc.) for which the system and its associated transducers are intended and found to be substantially equivalent to predicate devices.

Regarding diagnostic performance studies, the document contains no information on the following points:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

No details on a specific diagnostic performance test set are provided. The "testing" mentioned refers to safety and functional compliance, and comparison to predicate devices, not clinical diagnostic accuracy of an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as no diagnostic performance study is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as no diagnostic performance study is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a general-purpose ultrasound system, not an AI-powered diagnostic algorithm or an assist tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a general-purpose ultrasound system, not an AI-powered diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable as no diagnostic performance study is described.

8. The sample size for the training set

Not applicable. This device is a general-purpose ultrasound system. Any "new algorithm" mentioned in section 3 (page 1) would likely refer to internal signal processing or imaging algorithms, not a machine learning model trained on a large dataset for diagnostic output. No details about such training are provided.

9. How the ground truth for the training set was established

Not applicable as no training set for a diagnostic algorithm is mentioned.

Summary

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510(K) SUMMARY

APR 3 0 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: +86 755 2658 2551 Fax: +86 755 2658 2680

Contact Person:

Meng Xianjun

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: Jan. 08, 2010

Device Name: DC-7 Diagnostic Ultrasound System

Classification

Regulatory Class: II Review Category: Tier II 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-1YN)

21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-1YO)

21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

3. Marketed Device:

DC-7 Diagnostic Ultrasound System is substantially equivalent to the following devices: Mindray DC-7 (K#092691), Mindray DC-3 (K#091941), GE Logiq PS (K#060993), GE Voluson 730 (K#041688).

Compared to the original submission (K#092691), the technological characteristics are almost identical in this submission except for the new features and indications such as

B-1

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new probes, software functions, new algorithm and etc.

The only unique feature found on the DC-7 compared to the predicate devices is the calculation of the ABI(ankle-brachial index), this feature does not affect the safety or effectiveness of the device.

4. Device Description:

5. Intended Use:

6. Safety Considerations:

The DC-7 Diagnostic Ultrasound System had been tested as Track 3 Device per the FDA Guidance document "Information for Manufacturers Sccking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued in September 2008. The acoustic output is measured and calculated per NEMA UD 2: 2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment and NEMA UD 3: 2004 Standards for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4 and ISO 10993-1.

Conclusion:

The conclusions drawn from testing of the DC-7 Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

JUN 3 - 2010

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

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Robert Mosenkis President CITECH 5200 Butler Pike Plymouth Meeting, PA 19462

Re: K101041 Trade/Device Name: DC-7 Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II .. Product Code: IYN, ITX, and IYO Dated: April 13, 2010 Received: April 14, 2010

Dear Mr. Mosenkis:

This letter corrects our substantially equivalent letter of April 30, 2010.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the DC-7 Diagnostic Ultrasound Systems, as described in your premarket notification:

Transducer Model Number

3C5A			7L5
C5-2			L12-4
V10-4			L7-3
V10-4B			L11-4
6C2			L14-6
7L4A			2P2

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4CD4P4-2P7-3		P12-47LT4DE10-3
-------------------------------------------------------------------------------------------------------------------------------------------------------------------	--	----------------------------------------------------------------------------------------------------------------------------------------------------------------------

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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 (301) ) 796-6542.

Sincerely vours.

Alberto S.

for: Donald St. Pierre
Acting Director

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

510(k) Number (if known):

Device Name: DC-7 Diagnostic Ultrasound System

Indications For Use:

The DC-7 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdominal, cardiac, small organ (breast, testes, thyroid, elc.), peripheral vascular, fetal, transvaginal, pediatric, neonatal cephalic, musculoskeletal(conventional and superficial), intraoperative and transcranial 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)

Robert L. Becker
(Division Sign-Off)

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

510K K101041

Page 1 of

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Mindray Co. Ltd.- DC-7 Diagnostic Ultrasound System

System	X
Model:	DC-7
510(k) Number(s)

Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P	Note 1,2, 3, 4,7,8
Abdominal	P	P	P	P	P	P	P	Note 1,2, 3, 4,5,7,8
Intraoperative (specify)*	N	N	N		N	N	N	Note 1,2,4,7,8
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	P	P	Note 1, 2, 4,5,7,8
Small organ (specify) **	P	P	P		P	P	P	Note1 , 2, 4,7,8
Neonatal Cephalic	P	P	P	P	P	P	P	Note 1, 2, 4,5,7,8
Adult Cephalic	P	P	P	P	P	P	P	Note1, 2. 4,5,7,8
Trans-rectal	P	P	P		P	()	P	Note 1,2,3,4,7,8
Trans-vaginal	P	P	P		P	P	P	Note 1,2,3,4,7,8
Trans-urethral
Trans-esuph.(non-Card.)
Musculo-skeletal Conventional	P	P	P .		P	p	P	Note 1,2,4,7,8
Musculo-skeletal Superficial	P	P	P		P	P	P	Note 1,2,4,7,8
Intravascular
Cardiac Adult	P	P	P	P	P	P	P	Note 1,2,5,7,8
Cardiac Pediatric	P	P	P	P	P	P	P	Note 1,2,5,7,8
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	p		P	P	P	Note 1,2,4,7,8
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.

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

Notc 2; Smart3D

Note 3:4D(Real-time 3D)

Note 4: iScape

Note 5: TDI

Note6: Contrast Imaging

Note7: Color M

Note8: Biopsy Guidance

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

Concurrence of CDRH. Office of Revice Evaluation(ODE)

1.6

. ,

: , :

Diagnostic Ultrasound Indications for Use Form

Prescription USE (Per 21 CFR 801.109)

Robert Becker
(Division Sign-Off)

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

510K K101041

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

. .

. . . . . .

System				Transducer		X
Model:			3C5A
510(k) Number(s)			K092691

						Mode of Operation
Clinical Application	B	M	PWD	CWI)	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P	Note 1, 2, 4,7,8
Abdominal	P	P	P		P	P	P	Note 1, 2, 4,7,8
Intraoperative (specify) *
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	Note 1, 2, 4,7,8
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional	P	P	P		P	P	P	Note 1, 2, 4,7,8
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	P		P	P	P	Note 1, 2, 4,7,8
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.
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: Contrast ImagingNote7: Color M
Note8: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)

Diagnostic Ultrasound Indications for Use Form

Prescription USE (Per 21 CFR 801.109)

Robert Becker
(Division Sign Off)

Division of Radio Office of In Vitro Diagnostic Device Evaluation and Safety

510K K101041

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

Model:			C5-2
510(k) Number(s)			K092691

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P	Note 1, 2, 4,7,8
Abdominal	P	P	P		P	P	P	Note 1, 2, 4,7,8
Intraoperative (specify) *
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	Note 1, 2, 4,7,8
Small organ(specify) * *
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal Conventional	P	P	P		P	P	P	Note 1, 2, 4,7,8
Musculo-skeletal Superficial
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-csoph.(Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	P		P	P	P	Note 1, 2, 4,7,8
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.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScapeNoteS: TDI
Note6: Contrast Imaging
Note7: Color M
Note8: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)


	Mode of Operation
Clinical Application	13	M	I'WD	CWD	Color	Amplitude	Combined	Other (specify)
					Doppler	Doppler	(specify)
Ophthalmic						P	P	Note 1. 2. 4,7,8
Fetal	P	p	11		P
Abdominal
Intraoperative (specify) *
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify) * ·
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P		P	P	P	Note 1, 2, 4,7,8
Trans-vaginal	P	P	P		p	P	P	Note 1, 2, 4,7,8
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; Papreviously 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.
** Small organ-breast, thyroid, testes, etc.
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: Contrast Imaging
Note7: Color M
Note8: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

メ

System

Transduccr

(Division Sign/DII)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluatiory and Safety

510K K101041

(Division Sign-Off)

Prescription USE (Per 21 CFR 801.109)

・

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

Diagnostic Ultrasound Indications for Use FormTransducer

メ

System V 10-4 Model: 510(k) Number(s) KU:2691

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Device Office of In Vitro Diagnostic Device Evalyation and Salety

510K K101041

ব

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

・

System

Model:	V10-4B
510(k) Number(s)	K092691
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P	Note 1, 2, 4,7,8
Abdominal
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P		P	P	P	Note 1, 2, 4,7,8
Trans-vaginal	P	P	P		P	P	P	Note 1, 2, 4,7,8
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.
**Small organ-breast, thyroid, testes, etc.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note 5: TDI
Note6: Contrast Imaging
Note7: Color M
Note8: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Diagnostic Ultrasound Indications for Use Form

Transducer

Prescription USE (Per.21 CFR 801.109)

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

510K K101041

: 上一篇:

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

System Modcl:

510(k) Number(s)

	Transducer
6C2
King2017

Clinical Application	Mode of Operation
	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P	Note 1, 2, 4,7,8
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	Note 1, 2, 4,7,8
Small organ(specify)**
Neonatal Cephalic	P	P	P		P	P	P	Note 1, 2, 4,7,8
Adult Cephalic	P	P	P		P	P	P	Note 1, 2, 4,7,8
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-csoph.(non-Card.)
Musculo-skeletal Conventional	P	P	P		P	P	P	Note 1, 2, 4,7,8
Musculo-skeletal Superficial	P	P	P		P	P	P	Note 1, 2, 4,7,8
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	P		P	P	P	Note 1; 2, 4,7,8
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.
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: Contrast Imaging
Note7: Color M
Note8: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per.21 CER 801.109)

Robert Becker
(Division Sign-Off)

510K

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

റ

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

Transducer System × 7L4A Model: Kugayaan うけの(k) Number(s) Mode of Operation Clinical Application Color Amplitude Combined PWD CWD છ M Other (specify) Dopples Doppicr (spccify) Ophthalmic どこはし Ahdominal P P . P P P P Note 1.2. 4.7,8 Intraoperative (specify) lutraoperative (Neuro) l.aparoscopic l'ediatric p p P P p P Note 1.2. 4.7.8 Sinall organ(specify)" " ין P P P P P Note 1,2, 4,7,8 Noonatal Cophalic P P P P P P Note 1.2. 4.7,8 Adult Cophalic 『rans-rectat Trans-vaginal Trans-urethral Trans-csoph. (non-Card.) Musculo-skeletal Conventional P P P P P P Nosc 1,2, 4,7,8 Musculo-skelctal Superficial p p p p P P Note 1,2, 4,7,8 Intravascular Cardiac Adult Cardiac Pediatric Intravascular (Cardiac) Trans-csoph.(Cardiac) Intra-Cardiac Peripheral Vascular P P P P P P Note t,2, 4,7,8 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. Note I : Tissue Harmonic Imaging. The feature does not use contrast agents. Note 2: Sman3D Note 3: 4D(Real-time 3D) Note 4: iScape NoteS : TDI Note6 : Contrast Imaging Note7: Color M Note8 : Biopsy Guidance (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

Robert Beecher

Division of Radiotogical D stic Device Evaluation and Safety Office of In

610K K101041

Diagnostic Ultrasound Indications for Use Form

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

System				Transducer		X
Model:			7L5
510(k) Number(s)			K092011

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P	Note 1,2, 4,7,8
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	Note 1,2, 4,7,8
Small organ(specify)**	P	P	P		P	P	P	Note 1,2, 4,7,8
Neonatal Cephalic	P	P	P		P	P	P	Note 1,2, 4,7,8
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional	P	P	P		P	P	P	Note 1,2, 4,7,8
Musculo-skeletal Superficial	P	P	P		P	P	P	Note 1,2, 4,7,8
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	P		P	P	P	Note 1,2, 4,7,8
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.
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 : Contrast ImagingNote7 : Color M
Note8 : Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

. . . .

Prescription USE (Per 21 CFR 801.109)

10K

Robert R. Rockey
(Division Sign-Off)

Division of Radiological Devic Office of In Vitro Disgnastio Device Evely ation and Sefety

. ﺍ

. . .

, :

. . ·

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

System Model:

Transducct × LI2-4 . Колдыя:

510(k) Number(s)

510(k) Number(s)
	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P	Note 1,2,4,7,8
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	Note 1.2, 4,7,8
Small organ(specify)**	P	P	P		P	P	P	Note 1.2. 4.7.8
Neonatal Cephalic	P	P	P		P	P	P	Note 1,2, 4,7,8
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal Conventional	P	P	P		P	P	P	Note 1,2, 4,7,8
Musculo-skeletal Superficial	P	P	P		P	P	P	Note 1,2, 4,7,8
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	P		P	P	P	Note 1,2, 4,7,8
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.
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 : Contrast Imaging
Note7 : Color M
Note8 : Biopsy Guidance(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Prescription USE (Per 21 CFR 801.109)

: :

. .

・

Robert Heckert

Sign Off) (Division Sign-Off)
Office of In Vitro Digical Devices
Office of In Vitro Diegrossic Devices
Office of In Vitro Diegnositic Devices Evaluation and Safety

510K. K10641

9 .

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

System		Transducer	X
Model:	L.7-3
510(k) Number(s)	K002091

Mode of Operation
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P	Note 1,2, 4,7,8
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	Note 1,2, 4,7,8
Small organ(specify)**	P	P	P		P	P	P	Note 1,2, 4,7,8
Neonatal Cephalic	P	P	P		P	P	P	Note 1,2, 4,7,8
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional	P	P	P		P	P	P	Note 1,2, 4,7,8
Musculo-skeletal Superficial	P	P	P		P	P	P	Note 1,2, 4,7,8
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	P		P	P	P	Note 1,2, 4,7,8
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.
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 : Contrast Imaging
Note7 : Color M
Note8 : Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

Robert Becker

(Division Sign-Off) Office of In Vitro Division Sign-Off)
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices Evaluation and Safaty

§10K KID1041

、

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

System Model:

L | | - 4

510(k) Number(s)
	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P	Note 1,2, 4,7,8
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	Note 1,2, 4,7,8
Small organ(specify)**	P	P	P		P	P	P	Note 1,2, 4,7,8
Neonatal Cephalic	P	P	P		P	P	P	Note 1,2, 4,7,8
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-csoph. (non-Card.)
Musculo-skeletal Conventional	P	P	P		P	P	P	Note 1,2, 4,7,8
Musculo-skeletal Superficial	P	P	P		P	P	P	Note 1,2, 4,7,8
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	P		P	P	P	Note 1,2, 4,7,8
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.
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: Contrast Imaging
Note7: Color M
Note8 : Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Prescription USE (Per 21 CFR 801 109)

· .

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

s10K K101041

. . .

{16}------------------------------------------------

System				Transducer		X
Model:			1.14-6
510(k) Number(s)			K892601

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalinic
Fetal
Abdominal	P	P	P		P	P	P	Note 1,2, 4,7,8
Intraoperative (specify) *
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	Note 1,2, 4,7,8
Small organ(specify)**	P	P	P		P	P	P	Note 1,2, 4,7,8
Neonatal Cephalic	P	P	P		P	P	P	Note 1.2, 4.7.8
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal Conventional	P	P	P		P	P	P	Note 1,2, 4,7,8
Musculo-skeletal Superficial	P	P	P		P	P	P	Note 1,2, 4,7,8
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	P		P	P	P	Note 1,2, 4,7,8
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.
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: Contrast Imaging
Note7: Color M
Note8: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

Robert W. Becker

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

510K K101041

{17}------------------------------------------------

System Model:

2P2 に092691

510(k) Number(s)

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P	Note 1, 2,5,7,8
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	P	P	Note 1, 2,5,7,8
Small organ (specify)**
Neonatal Cephalic	P	P	P	P	P	P	P	Note 1, 2,5,7,8
Adult Cephalic	P	P	P	P	P	P	P	Note 1, 2,5,7,8
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional	!
Musculo-skeletal Superficial
Intravascular
Cardiac Adult	P	P	P	P	P	P	P	Note 1, 2,5,7,8
Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2,5,7,8
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: Cambined modes: B+M. PW+B. Color + B. PW +Color+ B. PW +Color+ B. Power + PW +B.

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

Intraoperative includes abdominal, thoracic, and vascular etc. ** Small organ-breast, thyroid, testes, etc. Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. Note 2: Smart3D Note 3: 4D(Real-time 3D) Note 4: iScapc Notes: TDI Note6: Contrast Imaging Noie7: Color M Norc8: Biopsy Guidance

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

Robert Stockey
(Division Sign-Off)

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

510K K101091

{18}------------------------------------------------

System				Transducer		X
Model:	4CD4
510(k) Number(s)			K192691

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P	Note 1,2, 3, 4,7
Abdominal	P	P	P		P	P	P	Note 1,2, 3, 4,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	Note 1,2, 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
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.
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 : Contrast Imaging
Note7 : Color M
Note8 : Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
System				Transducer		X
Model:		P4-2
510(k) Number(s)

						Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	N	N	N	N	N	N	N	Note 1, 2,5,7,8
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	N	N	N	N	N	N	N	Note 1, 2,5,7,8
Small organ(specify) **
Neonatal Cephalic	N	N	N	N	N	N	N	Note 1, 2,5,7,8
Adult Cephalic	N	N	N	N	N	N	N	Note 1, 2,5,7,8
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional
Musculo-skelctal Superficial
Intravascular
Cardiac Adult	N	N	N	N	N	N	N	Note 1, 2,5,7,8
Cardiac Pediatric	N	N	N	N	N	N	N	Note 1, 2,5,7,8
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.
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: Contrast Imaging
Note7: Color MNote8: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

Prescription USE (Per 21 CFR 801.109)

Robert M. Becker
(Division Sign-Off)

Division of Radiological Dev Office of In Vitro Diagnostic Dev ice Evaluation and Safety

610K. B101041

14 .

{19}------------------------------------------------

. :

: :

610K

. .

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

ice of In Vitro Diagnostic Device Evaluation and Safety

SID 104

....

. ・

{20}------------------------------------------------

×
× -------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Sysiem Model:

. .

· ・. :

...

Transduccr P7-3

510(k) Number(s)

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	N	N	N	N	N	N	N	Note 1, 2,5,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	N	N	N	N	N	N	N	Note 1, 2,5,7
Small organ(specify)**
Neonatal Cephalic	N	N	N	N	N	N	N	Note 1, 2,5,7
Adult Cephalic	N	N	N	N	N	N	N	Note 1, 2,5,7
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional	N	N	N	N	N	N	N	Note 1, 2,7
Musculo-skeletal Superficial
Intravascular
Cardiac Adult	N	N	N	N	N	N	N	Note 1, 2,5,7
Cardiac Pediatric	N	N	N	N	N	N	N	Note 1, 2,5,7
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular
Other (specify)***
N=new indication; P=previously cicared 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.
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: Contrast Imaging
Note7: Color M
Note8: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 2019ocke

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

510K.

: .

. .

・

. ィ

{21}------------------------------------------------

System				Transducer		X
Model:	P12-4
510(k) Number(s)

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	N	N	N	N	N	N	N	Note 1, 2,5,7
Intraoperative (specify)*
Intraoperative (Neuro)
Laparoscopic
Pediatric	N	N	N	N	N	N	N	Note 1, 2,5,7
Small organ(specify) **
Neonatal Cephalic	N	N	N	N	N	N	N	Note 1, 2,5,7
Adult Cephalic	N	N	N	N	N	N	N	Note 1, 2,5,7
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional	N	N	N		N	N	N	Note 1, 2,7
Musculo-skeletal Superficial
Intravascular
Cardiac Adult	N	N	N	N	N	N	N	Note 1, 2,5,7
Cardiac Pediatric	N	N	N	N	N	N	N	Note 1, 2,5,7
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.
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: Contrast Imaging
Note7: Color M
Note8: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)

・

1 - 1 - 1 -

Prescription USE (Per 21 CFR 801.109)

510K

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

. ·

. . .

」

. '

{22}------------------------------------------------

System
Model:	Model:

Transducer 7LT4

510(k) Number(s)

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal	N	N	N		N	N	N	Note 1,2, 4,7,8
Intraoperative (specify)*	N	N	N		N	N	N	Note 1,2, 4,7,8
Intraoperative (Neuro)
Laparoscopic
Pediatric	N	N	N		N	N	N	Note 1,2, 4,7,8
Small organ(specify)**	N	N	N		N	N	N	Note 1,2, 4,7,8
Neonatal Cephalic	N	N	N		N	N	N	Note 1,2, 4,7,8
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.(non-Card.)
Musculo-skeletal Conventional	N	N	N		N	N	N	Note 1,2, 4,7,8
Musculo-skeletal Superficial	N	N	N		N	N	N	Note 1,2, 4,7,8
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-Cardiac
Peripheral Vascular	N	N	N		N	N	N	Note 1,2, 4,7,8
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.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3: 4D(Real-time 3D)
Note 4: iScape
Note 5: TDI
Note 6: Contrast Imaging
Note 7: Color M
Note 8: Biopsy Guidance
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

Robert Becker
(Division Sign-Off)

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

510K K101041 ?

{23}------------------------------------------------

System
Model:	DE10-3
Transducer	X
510(k) Number(s)

Clinical Application	B	M	PWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal	N	N	N	N	N	N	Note 1, 2,3, 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, 2, 3,4,7
Trans-vaginal	N	N	N	N	N	N	Note 1, 2, 3,4,7
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=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.

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

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: Contrast Imaging

Note7: Color M

Note8: Biopsy Guidance

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

. .

・

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. 1972 - 1992

Prescription USE (Per 21 CFR 80J . 199)

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(Division Sign-Off)
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510K K101041

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Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

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