The DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.

Device Description

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW mode, Color-Mode, Color M-Mode, Power/Dirpower Mode, TDI mode, 4D mode or the combined mode (i.e. B/M-Mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 3 MHz to 10.0 MHz.

AI/ML Overview

The provided text is a 510(k) summary for the Shenzhen Mindray Bio-medical Electronics Co., LTD DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to predicate devices and adherence to medical safety standards rather than establishing new performance criteria through clinical studies.

Therefore, the document does NOT contain information regarding:

Specific acceptance criteria framed as quantitative metrics (e.g., sensitivity, specificity, accuracy).
Details of a study proving the device meets acceptance criteria in terms of clinical performance.
Sample sizes used for test or training sets for an AI/algorithm.
Data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth related to clinical performance.
Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human readers with/without AI assistance.
Standalone algorithm performance studies.
The type of ground truth used as it relates to clinical performance studies.
The sample size for the training set or how ground truth was established for a training set.

The document primarily outlines the device's technical specifications, intended uses, and lists applicable safety and electrical standards it conforms to. It states that the device has been evaluated for "acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety" and found to conform with applicable medical safety standards.

However, based on the provided text, I can infer the "acceptance criteria" and "study" in a regulatory context, which is demonstrating substantial equivalence to predicate devices and compliance with recognized standards.

Here's a breakdown of what can be extracted based on that understanding:

1. Table of "Acceptance Criteria" and "Reported Device Performance":

In the context of a 510(k) submission for a diagnostic ultrasound system like this, the "acceptance criteria" are not reported as specific performance metrics (like sensitivity/specificity) but as conformance to established safety and performance standards, and substantial equivalence to legally marketed predicate devices. The "reported device performance" is the statement of conformity.

Acceptance Criteria (Regulatory Context)	Reported Device Performance (as stated in the 510(k) Summary)
Substantial Equivalence to Predicate Devices (similar technological characteristics, comparable safety & effectiveness, same intended uses)	"DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices: Mindray DC-7 (K103583), Mindray M7 (K103677), GE Voluson E8 (K101236), Mindray DC-T6 (K110199), Sonosite M-Turbo (K101757), Siemens ACUSON S2000 (K112596), Siemens ACUSON SEQUOIA 512 (K063085), GE LOGIQ e (K102256). They have the similar technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate devices."
Conformance with Applicable Medical Safety Standards	"DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37, IEC 62304, IEC 62366, UL 60601-1, ISO14971, UD 2, UD 3 and ISO 10993-1."
Quality System Compliance	"The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems."
Intended Uses are Consistent with Traditional Clinical Practices and FDA Guidelines	"Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination."

2. Sample size used for the test set and the data provenance:

The document does not detail specific clinical studies with test sets, sample sizes, or data provenance (country, retrospective/prospective) for proving diagnostic performance. The evaluations mentioned are primarily for safety, electrical, and mechanical conformity.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no described clinical performance study with a test set requiring expert-established ground truth.

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

Not applicable.

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. The device described is a general diagnostic ultrasound system, not an AI-powered diagnostic algorithm aiding human readers.

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

Not applicable. This is a diagnostic ultrasound system, not a standalone algorithm.

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

Not applicable in the context of clinical diagnostic performance. For technical evaluations, the "ground truth" would be the specifications and requirements defined by the applicable standards (e.g., standard measures for acoustic output, material properties for biocompatibility testing).

8. The sample size for the training set:

Not applicable, as no described AI/algorithm training process.

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

Not applicable.

Summary

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510(K) SUMMARY

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

The assigned 510(k) number is: < 113647.

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 5604 Fax: +86 755 2658 2680

Contact Person:

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

Date Prepared: October 17, 2011

2. Device Name: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic

Ultrasound System

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

3. Device Description:

B-1

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combined mode (i.e. B/M-Mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 3 MHz to 10.0 MHz.

4. Intended Use:

5. Comparison with Predicate Devices:

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

Predicate Device	Manufacturer	Model	510(k) Control Number
1	Mindray	DC-7	K103583
2	Mindray	M7	K103677
3	GE	Voluson E8	K101236
4	Mindray	DC-T6	K110199
5	Sonosite	M-Turbo	K101757
6	Siemens	ACUSON S2000	K112596
7	Siemens	ACUSON SEQUOIA 512	K063085
8	GE	LOGIQ e	K102256

They have the similar 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:

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S 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: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC

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60601-2-37, IEC 62304, IEC 62366,UL 60601-1, ISO14971, UD 2, UD 3 and ISO 10993-1.

Conclusion:

Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

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

DEC 1 6 2011

Re: K113647

Trade/Device Name: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8 EXP/DC-8S Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO and ITX Dated: December 8, 2011 Received: December 12, 2011

Dear Mr. Rongero:

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

Transducer Model Number

C5-2EC7-3EL12-3E	L14-6NEL14-6WEP4-2E	D6-2ED8-3EV11-3E
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/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 Lauren Hefner at (301) 796-6881.

Sincerely yours,

Mary S. Pastel: Sc.D. 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-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System

Indications For Use:

× Prescription Use (Part 21 CFR 801 Subpart D)

510K

AND/OR

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

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

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

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

Page 1 of ー

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Diagnostic Ultrasound Indications For Use Format

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System System: Transducer:

N/A

Clinical Application							Mode of Operation
General (TrackI Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	N	N	Note 1, 2,3, 4,6,7
	Abdominal	N	N	N	N	N	N	N	Note 1, 2,3, 4,5,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1, 2,3, 4,5,6
	Small Organ (Specify**)	N	N	N	N	N	N	N	Note 1,2, 4,6,7
Fetal Imaging &Other	Neonatal Cephalic	N	N	N	N	N	N	N	Note 1, 2,4,5,6
	Adult Cephalic	N	N	N	N	N	N	N	Note 1, 2,4,5,6
	Trans-rectal	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	Trans-vaginal	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	Musculo-skeletal (Superficial)	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	Intravascular
	Cardiac Adult	N	N	N	N	N	N	N	Note 1, 2,4,5,6
	Cardiac Pediatric	N	N	N	N	N	N	N	Note 1, 2,4,5,6
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	N	N	N	N	N	N	N	Note 1, 2, 4,6,
	Other (Specify***)	N	N	N	N	N	N	N	Note 1, 2, 4,6,
	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.
	***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
	Note8: Elastography
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
Clinical Application		Mode of Operation
General (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	Abdominal	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	Small Organ (Specify**)
Fetal Imaging &Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	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.
	*** 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: iScapeNote5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

Clinical Application		Mode of Operation
General (Track I Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	N	Note 1, 2, 4,6,7
	Abdominal	N	N	N		N	N	N	Note 1, 2, 4,6,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1, 2, 4,6,7
	Small Organ (Specify**)
Fetal Imaging &	Neonatal Cephalic
Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel	N	N	N		N	N	N	Note 1, 2, 4,6,7
vessel	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.
	*** 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
	Note8: Elastography
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Clinical Application		Mode of Operation
General (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	Small Organ (Specify**)	N	N	N	N	N	N	N	Note 1,2, 4,6,7,8
Fetal Imaging &	Neonatal Cephalic	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	Musculo-skeletal (Superficial)	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
vessel	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、PW +Color+B、Power + PW+B.
	* Intraoperative includes abdominal, thoracic, and vascular etc.
	* * Small organ-breast, thyroid, testes.*** 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 MNote7: Biopsy Guidance
	Note8: Elastography
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
	Prescription USE (Per 21 CFR 801.109)

					(Division Sign-Off)
Transducer: L14-6NE
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
General (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal	N	N	N		N	N	N	Note 1,2, 4,6,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1,2, 4,6,
	Small Organ (Specify**)	N	N	N		N	N	N	Note 1,2, 4,6,7
	Neonatal Cephalic	N	N	N		N	N	N	Note 1,2, 4,6,
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	N	N	N		N	N	N	Note 1,2, 4,6,
	Musculo-skeletal (Superficial)	N	N	N		N	N	N	Note 1,2, 4,6,
Cardiac	Intravascular
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	N	N	N		N	N	N	Note 1,2, 4,6,
	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.
***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
Note8: Elastography
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Clinical Application	Mode of Operation
General (Track I Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	N	N	N	N	N	N	N	Note 1,2, 4,6,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1,2, 4,6,7
	Small Organ (Specify**)	N	N	N	N	N	N	N	Note 1,2, 4,6,7,8
Fetal Imaging &Other	Neonatal Cephalic	N	N	N	N	N	N	N	Note 1,2, 4,6,7
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	N	N	N	N	N	N	N	Note 1,2, 4,6,7
	Musculo-skeletal (Superficial)	N	N	N	N	N	N	N	Note 1,2, 4,6,7
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	N	N	N	N	N	N	N	Note 1,2, 4,6,7
	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.
	***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
	Note8: Elastography
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Clinical Application						Mode of Operation
	General (TrackI Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
		Fetal
		Abdominal	N	N	N	N	N	N	N	Note 1, 2,4,5,6,7
		Intra-operative (Specify*)
		Intra-operative (Neuro)
		Laparoscopic
		Pediatric	N	N	N	N	N	N	N	Note 1, 2,4,5,6,7
		Small Organ (Specify**)
Fetal Imaging &Other		Neonatal Cephalic	N	N	N	N	N	N	N	Note 1, 2,4,5,6,7
		Adult Cephalic	N	N	N	N	N	N	N	Note 1, 2,4,5,6,7
		Trans-rectal
		Trans-vaginal
		Trans-urethral
		Trans-esoph. (non-Card.)
		Musculo-skeletal (Conventional)
		Musculo-skeletal (Superficial)
		Intravascular
Cardiac		Cardiac Adult	N	N	N	N	N	N	N	Note 1, 2,4,5,6,
		Cardiac Pediatric	N	N	N	N	N	N	N	Note 1, 2,4,5,6,
		Intravascular (Cardiac)
		Trans-esoph. (Cardiac)
		Intra-cardiac
Peripheralvessel		Peripheral vessel
		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.
	***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
	Note8: Elastography
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)

	Clinical Application		Mode of Operation
General (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	N	Note1, 2, 3, 4,6
	Abdominal	N	N	N		N	N	N	Note1, 2, 3, 4,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1,2, 3, 4,6
	Small Organ (Specify**)
Fetal Imaging &Other	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
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	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.
	***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
	Note8: Elastography
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
	Prescription USE (Per 21 CFR 801.109)
				IDionsion Sign-Off)
	Clinical Application						Mode of Operation
General (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	N	Note1,2, 3, 4,6
	Abdominal	N	N	N		N	N	N	Note1,2, 3, 4,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1,2, 3, 4,6
	Small Organ (Specify**)
	Fetal Imaging & Neonatal Cephalic
Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	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.
	*** 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
	Note8: Elastography
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
	Prescription USE (Per 21 CFR 801.109)

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

510K

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

Transducer: CS-2E

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

510K

Prescription USE (Per 21 CFR 801.109) (Division Sign-Off)

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

008-3

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

C7-3E Transducer:

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off)

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

K113647
510K

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

L12-3E Transducer:

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

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

K113647
510K

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

Transducer: LI4-6NE

System:

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System

rescription USE (Per

(Division Sign-Off)

510K

008-6

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

LI4-6WE Transducer:

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

.109)

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510K

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

Transducer: P4-2E

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

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Radiological Devices

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

510K

008-8

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

Transducer: D6-2E

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

Division of Radiological Devices e Evaluation and Safety Office of In Vitro agnastic L

510K.

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

Transducer: D8-3E

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

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Division of Hadlological Bovice Evaluation and Safety

510K

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

VII-3E Transducer:

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

	Clinical Application	Mode of Operation
General (Track1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	N	Note 1, 2, 4,6,7
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Fetal Imaging & Neonatal Cephalic
Other	Adult Cephalic
	Trans-rectal	N	N	N		N	N	N	Note 1, 2, 4,6,7
	Trans-vaginal	N	N	N		N	N	N	Note 1, 2, 4,6,7
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)	N	N	N		N	N	N	Note 1, 2, 4,6,
	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.
	***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
	Note8: Elastography
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)

	Prescription USE (Per 21 CFR 801.109)

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

510K

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.