The DC-70/ DC-70T / DC-70 Pro/ DC-70 Exp/ DC-75/ DC-78/ DC-70S 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 and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel , intra-operative(abdominal, thoracic, and vascular) and urology exams.

Device Description

DC-70/ DC-70T /DC-70 Pro/ DC-70 Exp/ DC-75/ DC-78/ DC-70S is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, P CW-Mode, Color-Mode , Power/Dirpower Mode, THI, Smart3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Elastography, Contrast imaging (Contrast agent for Liver and LOV) 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, Convex array, Phased array, Volume and Pencil probe.

AI/ML Overview

Here's an analysis of the provided information regarding the acceptance criteria and supporting studies for the Shenzhen Mindray Bio-medical Electronics Co., LTD DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System.

Important Note: This document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness as a PMA (Premarket Approval) application would. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily related to safety, performance aspects comparable to the predicate, and adherence to relevant standards. Clinical effectiveness studies are explicitly stated as "Not applicable."

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, the acceptance criteria are not typically expressed as specific performance metrics (like sensitivity/specificity) for a diagnostic task, but rather as compliance with safety standards and equivalence to predicate devices in terms of intended use and technological characteristics.

Acceptance Criteria Category	Reported Device Performance (Summary from Submission)
Intended Use Equivalence	The subject device has the same intended uses as the predicate devices (Mindray DC-70 (K163690) and DC-80 (K173471)).
Technological Characteristics Equivalence	The subject device has the same technological characteristics as the predicate devices, including B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, THI, Smart3D, 4D, iScape, TDI, Color M, Biopsy Guidance, Elastography, Contrast imaging, and combined modes. It also uses similar probes. All systems transmit ultrasonic energy, perform post-processing, and allow for specialized measurements and calculations.
Acoustic Output Safety	Acoustic power levels are below the FDA limits, same as the predicate device DC-70 (K163690).
Electrical and Physical Safety	Designed in compliance with FDA recognized electrical and physical safety standards, same as the predicate device DC-70 (K163690).
Biocompatibility	Evaluated for biocompatibility.
Cleaning and Disinfection Effectiveness	Evaluated for cleaning and disinfection effectiveness.
Thermal Safety	Evaluated for thermal safety.
Mechanical Safety	Evaluated for mechanical safety.
Software Life Cycle Processes	Designed in compliance with IEC 62304 (Medical device software Software life cycle processes).
Usability Engineering	Designed in compliance with IEC:62366 (Medical devices - application of usability engineering to medical devices) and IEC 60601-1-6 (Usability).
Risk Management	ISO14971 (Medical devices - Application of risk management to medical devices) followed.
Quality Systems	Design, development, and quality process conform with 21 CFR 820, ISO 9001, and ISO 13485 quality systems.

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

The submission explicitly states: "8. Clinical Studies Not applicable. The subject of this submission, DC-70/ DC-70T/ DC-70 Pro/ DC-70 Exp / DC-75/ DC-78/ DC-70S Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."

Therefore, there is no mention of a traditional test set of patient data, sample size, or data provenance (country of origin, retrospective/prospective) for proving device performance in a diagnostic context. The assessment relies on engineering and performance testing against standards and comparison to predicate devices.

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

As clinical studies were "Not applicable," there is no mention of experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used for diagnostic performance evaluation.

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 submission explicitly states no clinical studies were required or performed. There is no mention of AI features (other than "Smart3D", "Smart face", "Smart plane CNS", which are likely imaging enhancement features rather than AI for diagnostic interpretation) that would necessitate a comparative effectiveness study with human readers.

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

Not applicable, as no clinical studies were conducted for diagnostic performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For a 510(k) for an ultrasound system, the "ground truth" for demonstrating substantial equivalence primarily relates to:

Compliance with recognized standards: The physical and electrical safety, acoustic output, and electromagnetic compatibility are tested against established engineering and medical device standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, IEC 62366, IEC 60601-1-6, ISO14971, UD 2, UD 3, ISO 10993-1).
Performance specifications: The ultrasound system's various modes (B-Mode, M-Mode, etc.) and transducer capabilities are assessed against their defined technical specifications and compared to those of predicate devices.
Physical and material properties: Biocompatibility, cleaning/disinfection effectiveness are evaluated according to relevant standards.

8. The Sample Size for the Training Set

Not applicable. No AI/ML model requiring a training set is described as the primary subject of the 510(k) for demonstrating substantial equivalence as a diagnostic device. The "Smart" features mentioned are likely integrated software functionalities rather than standalone AI for diagnostic interpretation requiring significant training data submitted for review.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for an AI/ML model for diagnostic interpretation is discussed.

Summary

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Shenzhen Mindray Bio-Medical Electronics Co., LTD Zhang Wei Engineer of Technical Regulation Keji 12th Road South, Hi-tech Industrial Park Shenzhen, Guangdong 518057 CHINA

January 9, 2019

Re: K181637

Trade/Device Name: DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX, LLZ Dated: December 25, 2018 Received: December 28, 2018

Dear Zhang Wei:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael D.'Hara For

Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K181637

Device Name

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System

Indications for Use (Describe)

The DC-70/ DC-70T / DC-70 Pro/ DC-70 Exp/ DC-78/ DC-70S 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 and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel , intra-operative(abdominal, thoracic, and vascular) and urology exams.

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

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Diagnostic Ultrasound Indications For Use Format

System: DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Transducer: N/A

Intended

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

Clinical Application		Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P	Note 1, 2,3, 4,6,7
	Abdominal	P	P	P	P	P	P	P	Note 1, 2,3,4,6,7,9
	Intra-operative (Specify*)	P	P	P	P	P	P	P	Note 1, 2, 4
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
	Small Organ (Specify**)	P	P	P	P	P	P	P	Note 1,2, 4,7,8
FetalImaging &Other	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1, 2,4,6,7
	Adult Cephalic	P	P	P	P	P	P	P	Note 1, 2,4,6,7
	Trans-rectal	P	P	P	P	P	P	P	Note 1, 2, 3,4,6,7
	Trans-vaginal	P	P	P	P	P	P	P	Note 1, 2, 3,4,6,7,8
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P	P	P	P	P	Note 1, 2, 4,6,7,8
	Musculo-skeletal (Superficial)	P	P	P	P	P	P	P	Note 1, 2, 4,7,8
	Intravascular								Note 1,
	Cardiac Adult	P	P	P	P	P	P	P	2,4,5,6,7,10
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)	N	N	N	N	N	N	N	Note 1, 5,6
	Intra-cardiac
Peripheralvessel	Peripheral vessel	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
	Other (Specify***)	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
	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
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
IntendedUse:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
	Clinical Application		B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
General(Track 1Only)	Specific (Track 1 & 3)
Ophthalmic	Ophthalmic
FetalImaging &Other	Fetal		P	P	P		P	P	P	Note 1, 2, 4,6,7
	Abdominal		P	P	P		P	P	P	Note 1, 2, 4,6,7,9
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric		P	P	P		P	P	P	Note 1, 2, 4,6,7
	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, 4,6,7
	Musculo-skeletal (Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel		P	P	P		P	P	P	Note 1, 2, 4,6,7
	Other (Specify***)
N=new indication; P=previously cleared by FDA(K150204); 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.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
Note8: Elastography
Note 9: Contrast imaging (Contrast agent for Liver)
Note 10: Contrast imaging (Contrast agent for LVO)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
IntendedUse:	Clinical Application		Mode of Operation
	General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Amplitude Doppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
		Fetal
		Abdominal	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
		Intra-operative (Specify*)
		Intra-operative (Neuro)
		Laparoscopic
FetalImaging &Other		Pediatric	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
		Small Organ (Specify**)
		Neonatal Cephalic	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
		Adult Cephalic
		Trans-rectal
		Trans-vaginal
		Trans-urethral
		Trans-esoph. (non-Card.)
		Musculo-skeletal (Conventional)
		Musculo-skeletal (Superficial)
		Intravascular
Cardiac		Cardiac Adult
		Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
		Intravascular (Cardiac)
		Trans-esoph. (Cardiac)
		Intra-cardiac
Peripheralvessel		Peripheral vessel	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
		Other (Specify***)
N=new indication; P=previously cleared by FDA(K150204); 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.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
Note8: Elastography
Note 9: Contrast imaging (Contrast agent for Liver)
Note 10: Contrast imaging (Contrast agent for LVO)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
IntendedUse:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application		Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Amplitudee Doppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
	Abdominal	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
	Small Organ (Specify**)
FetalImaging &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(K150204); 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.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
IntendedUse:	Clinical Application		Mode of Operation
	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Amplitudee Doppler	Combined(specify)	Other (specify)
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Amplitudee Doppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
FetalImaging &Other	Fetal
	Abdominal	P	P	P		P	P	P	Note 1, 2, 4,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1, 2, 4,7
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2, 4,7,8
FetalImaging &Other	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
	Musculo-skeletal (Superficial)	P	P	P		P	P	P	Note 1, 2, 4,7
Cardiac	Intravascular
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	P	P	P		P	P	P	Note 1, 2, 4,7
	Other (Specify***)
N=new indication; P=previously cleared by FDA(K150204); 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.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
Note8: Elastography
Note 9: Contrast imaging (Contrast agent for Liver)
Note 10: Contrast imaging (Contrast agent for LVO)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
IntendedUse:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2, 4,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2, 4,7
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2, 4,7,8
FetalImaging &Other	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
	Musculo-skeletal (Superficial)	P	P	P		P	P	P	Note 1,2, 4,7
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2, 4,7
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K150204); 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.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography

	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
IntendedUse:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application						Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2, 4,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2, 4,7
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2, 4,7,8
FetalImaging &Other	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
	Musculo-skeletal (Superficial)	P	P	P		P	P	P	Note 1,2, 4,7
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2, 4,7
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K150204); 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.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
IntendedUse:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
FetalImaging &Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
	Trans-vaginal	P	P	P	P	P	P	N	Note 1, 2, 4,6,7,8
	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***)	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
	N=new indication; P=previously cleared by FDA(K150204); 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.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P	Note 1, 2, 4,6,7
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
FetalImaging &Other	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P	Note 1, 2, 4,6,7
	Trans-vaginal	P	P	P		P	P	P	Note 1, 2, 4,6,7,8
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)	P	P	P		P	P	P	Note 1, 2, 4,6,7
	N=new indication; P=previously cleared by FDA(K150204); 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.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
IntendedUse:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application						Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Amplitude Doppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P	Note 1, 2, 4,6,7
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
FetalImaging &Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P	Note 1, 2, 4,6,7
	Trans-vaginal	P	P	P		P	P	P	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
vessel	Other (Specify***)	P	P	P		P	P	P	Note 1, 2, 4,6,7
	N=new indication; P=previously cleared by FDA(K150204);						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.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

IntendedUse:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	P	Note 1, 2,4,6,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,6,7
	Small Organ (Specify**)
FetalImaging &Other	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1, 2,4,6,7
	Adult Cephalic	P	P	P	P	P	P	P	Note 1, 2,4,6,7
	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 1,2,4,5,6,7,10
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K150204); 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.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	P	Note 1,2,4,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1,2,4,6
	Small Organ (Specify**)
FetalImaging &Other	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,2,4,6
	Adult Cephalic	P	P	P	P	P	P	P	Note 1,2,4,6
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
Cardiac	Cardiac Adult	P	P	P	P	P	P	P	Note 1, 2,4,5,6
	Cardiac Pediatric	P	P	P	P	P	P	P	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(K150204); 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.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
IntendedUse:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application		Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Amplitude Doppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P	Note 1, 3, 4, 6, 7
	Abdominal	P	P	P	P	P	P	P	Note 1, 3, 4, 6, 7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
FetalImaging &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(K150204);						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.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Transducer: DE10-3E
IntendedUse:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic	P	P	P		P	P	P	Note 1, 3, 4, 6
FetalImaging &Other	Fetal
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P	Note 1, 3, 4, 6
	Trans-vaginal	P	P	P		P	P	P	Note 1, 3, 4, 6
	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(K150204); 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.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Transducer:	CW5s
IntendedUse:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
FetalImaging &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				P
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K150204); 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.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
IntendedUse:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
General(Track 1Only)	Clinical Application	Mode of Operation						Other (specify)
		Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler		Amplitudee Doppler	Combined(specify)
Ophthalmic	Ophthalmic
FetalImaging &Other	Fetal		P	P	P		P	P	P	Note 1,2, 4,7
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric		P	P	P		P	P	P	Note 1,2, 4,7
	Small Organ (Specify**)		P	P	P		P	P	P	Note 1,2, 4,7,8
	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)		P	P	P		P	P	P	Note 1,2, 4,7,8
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel		P	P	P		P	P	P	Note 1,2, 4,7
	Other (Specify***)
Intended	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Use:	Mode of OperationClinical Application
General
(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Amplitude Doppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P	Note 1, 3, 4, 6, 7
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
FetalImaging &Other	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P	Note 1, 3, 4, 6, 7
	Trans-vaginal	P	P	P		P	P	P	Note 1, 3, 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=new indication; P=previously cleared by FDA(K163690); 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.
	***()ther use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
General(Track 1Only)	Ophthalmic
FetalImaging &Other	Ophthalmic	P	P	P		P	P	P	Note 1, 2, 4, 6, 7
	Fetal
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P	Note 1, 2, 4, 6, 7
	Trans-vaginal	P	P	P		P	P	P	Note 1, 2, 4, 6, 7
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)	P	P	P		P	P	P	Note 1, 2, 4, 6, 7
N=new indication; P=previously cleared by FDA(K163690); 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.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
Note8: Elastography
Note 9: Contrast imaging (Contrast agent for Liver)
Note 10: Contrast imaging (Contrast agent for LVO)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIP)
Use:	Clinical Application						Mode of Operation
		Specific (Track 1 & 3)	B	M	PWD CWD	ColorDoppler	Amplitudee Doppler	Combined(specify)	Other (specify)
General(Track 1Only)	Ophthalmic	Ophthalmic
		Fetal	P	P	P	P	P	P	Note 1, 2, 4,6,7
		Abdominal	P	P	P	P	P	P	Note 1, 2, 4,6,7,9
		Intra-operative (Specify*)
		Intra-operative (Neuro)
		Laparoscopic
		Pediatric	P	P	P	P	P	P	Note 1, 2, 4,6,7
		Small Organ (Specify**)
FetalImaging &Other		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, 4,6,7
		Musculo-skeletal (Superficial)
		Intravascular
	Cardiac	Cardiac Adult
		Cardiac Pediatric
		Intravascular (Cardiac)
		Trans-esoph. (Cardiac)
		Intra-cardiac
Peripheralvessel		Peripheral vessel	P	P	P	P	P	P	Note 1, 2, 4,6,7
		Other (Specify***)
	N=new indication; P=previously cleared by FDA(K163690); 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.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

{4}------------------------------------------------

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: C5-2E

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

{5}------------------------------------------------

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: C11-3E

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follo Intended

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

System: DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Transducer: C7-3E

Intended

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

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: L12-3E

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

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: L14-6NE

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

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: L14-6WE

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

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: V11-3E Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follo

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

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

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: V11-3BE

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

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: V V 1 - 3 W E

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

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: P4-2E Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: P7-3E

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

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

System: DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Transducer: D6-2E ded 1

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

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
DE10-3E System:
Transducer:

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

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: CWS nsdu

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

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: L9-3E

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

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: DE11-3E

Transducer:

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

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: V V 1 - 3 HE

Intended Diagnostic ultrasound imaging or fluid flow analysis of the human body as follow

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

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: C5-1E Intended

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

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

Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application		Mode of Operation
		B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
General(Track 1Only)	Specific (Track 1 & 3)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
FetalImaging &Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
	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***)	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
	N=new indication; P=previously cleared by FDA(K163690); 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.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)

System: DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Transducer: CB10-4E Intended

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

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

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:Use:
	Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
General(Track 1Only)	Specific (Track 1 & 3)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	P	Note 1, 2,4,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,6
	Small Organ (Specify**)
FetalImaging &Other	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1, 2,4,6
	Adult Cephalic	P	P	P	P	P	P	P	Note 1, 2,4,6
	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, 2,4,5,6
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,5,6
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)
N=new indication; P=previously cleared by FDA(K163690); 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.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
Note8: Elastography
Note 9: Contrast imaging (Contrast agent for Liver)
Note 10: Contrast imaging (Contrast agent for LVO)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

System:	DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
Transducer:	P10-4E

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

{24}------------------------------------------------

IntendedUse:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	P	Note 1, 2,4, 6,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1, 2,4, 6,7
	Small Organ (Specify**)
FetalImaging &Other	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	P	P	Note 1, 2,4, 6,7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular								Note 1,
	Cardiac Adult	P	P	P	P	P	P	P	Note 1,2,4,5,6,7,10
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K163690); 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.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
IntendedUse:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application		Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P	Note 1, 3, 4, 6
	Abdominal	P	P	P		P	P	P	Note 1, 3, 4, 6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
FetalImaging &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(K163690);						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.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
IntendedUse:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
General(Track 1Only)	Specific (Track 1 & 3)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P	Note 1, 3, 4, 6
	Abdominal	P	P	P	P	P	P	P	Note 1, 3, 4, 6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
FetalImaging &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(K163690); 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.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
IntendedUse:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical ApplicationMode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
FetalImaging &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)	P	P	P	P	P	P	P	Note 1, 5,6
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K163690);						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.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
IntendedUse:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	B	M	PWD	CWD	ColorDoppler	Amplitude Doppler	Combined(specify)	Other (specify)
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Amplitude Doppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2, 4,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2, 4,7
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2, 4,7,8
FetalImaging &Other	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2, 4,7
	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
	Musculo-skeletal (Superficial)	P	P	P		P	P	P	Note 1,2, 4,7
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2, 4,7
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K173471); 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
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note 8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

System: DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Transducer: SP5-1E Intended

{25}------------------------------------------------

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: D6-2NE

{26}------------------------------------------------

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: D7-2E Intended

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

{27}------------------------------------------------

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: P7-3TE T ded

{28}------------------------------------------------

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: L14-5WE

Intended stic ultrasound imaging or fluid flow analysis of the human body as follo

{29}------------------------------------------------

System:	DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
Transducer:	L20-5E
IntendedUse:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Clinical Application					Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combinedmodes(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)	N	N	N		N	N	N	Note 1, 2, 4
FetalImaging &Other	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, 2, 4, 8
	Musculo-skeletal (Superficial)	N	N	N		N	N	N	Note 1, 2, 4, 8
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	N	N	N		N	N	N	Note 1, 2, 4
	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
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note 8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
IntendedUse:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
FetalImaging &Other	Fetal
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N	N	N	N	N	Note 1,2,4,6,7
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)	N	N	N	N	N	N	N	Note 1,2,4,6,7
	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.
	***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
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note 8: Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging (Contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

{30}------------------------------------------------

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: 6LB7E
Intended

{31}------------------------------------------------

System:	DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
Transducer:	SC6-1E
Intended

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

Clinical Application		Mode of Operation
General(Track 1Only)	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	N	N	N		N	N	N	Note 1, 2, 4,6,7,9
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
FetalImaging &Other	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, 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	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.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note 5: TDI
Note 6: Color M
Note 7: Biopsy Guidance
Note 8: Elastography
Note 9: Contrast imaging (Contrast agent for Liver)
Note 10: Contrast imaging(contrast agent for LVO)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
IntendedUse:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Amplitudee Doppler	Combined(specify)	Other (Specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	N	N	Note 1, 3, 4, 6,7
	Abdominal	N	N	N	N	N	N	N	Note 1, 3, 4,6,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
FetalImaging &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.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note 8: Elastography
	Note9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging(contrast agent for LVO)
IntendedUse:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	P	Note 1, 2, 4
	Intra-operative (Specify*)	P	P	P	P	P	P	P	Note 1, 2, 4
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1, 2, 4
	Small Organ (Specify**)	P	P	P	P	P	P	P	Note 1, 2, 4
FetalImaging &Other	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1, 2, 4
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P	P	P	P	P	Note 1, 2, 4
	Musculo-skeletal (Superficial)	P	P	P	P	P	P	P	Note 1, 2, 4
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	P	P	P	P	P	P	P	Note 1, 2, 4
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K173471); 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.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note9: Contrast imaging (Contrast agent for Liver)
	Note 10: Contrast imaging(contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: SD8-1E

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DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System System: Transducer: L16-4HE Intended

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

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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: K181637.

1. Submitter:

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Shenzhen, Guangdong, 518057, P. R. China Tel: +86 755 8188 5655 Fax: +86 755 2658 2680

Contact Person:

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

Date Prepared: May 25, 2018

Device Name: DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S 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) 21 CFR 892.2050 Picture Archiving and Communications System(LLZ)

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3. Device Description:

This system is a Track 3 device that employs an array of probes that include Linear array, Convex array, Phased array, Volume and Pencil probe.

4. Intended Use:

The DC-70/ DC-70T / DC-70 Pro/ DC-70 Exp/ DC-78/ DC-78/ DC-70S 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 and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel , intra-operative(abdominal, thoracic, and vascular) and urology exams.

5. Summary of Modifications

● New Added Transducers:

L14-5WE L20-5E 6LB7E SC6-IE SD8-1E L16-4HE

. New Added Needle-Guided Bracket:

NGB-035, NGB-039, NGB-009

● Main Added Features:

Add the contrast imaging(contrast agent for LVO) function to SP5-1E, P4-2E

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Add the contrast imaging(contrast agent for Liver) function to SC6-1E Add the elastography function to L14-5WE, L20-5E ,L9-3E

AutoEF

Smart face

Smart plane CNS

6. Comparison with Predicate Devices:

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic

Ultrasound System is comparable with and substantially equivalent to these predicate devices:

Predicate Device	Manufacturer	Model	510(k) Control Number
1. Primary predicate device	Mindray	DC-70	K163690
2. Reference device	Mindray	Resona 7	K171233
3. Reference device	Mindray	DC-80	K173471
4. Reference device	Mindray	M9	K171034
5. Reference device	Mindray	M6	K171579

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S has the same technological characteristics, is comparable in key safety and effectiveness features, and has the same intended uses and basic operating modes as the predicate devices. All systems transmit ultrasonic energy into patients and perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.

. Subject device DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S has the same intended uses as the predicated device DC-70(K163690) and DC-80 K173471

Subject Device	Predicate device
DC-70/DC-70T /DC-70 PRO/DC-70 EXP	DC-70(K163690)
The DC-70/ DC-70T / DC-70 Pro/ DC-70Exp/ DC-75/ DC-78/ DC-70S Diagnostic	The DC-70/ DC-70T / DC-70 Pro/ DC-70 Exp/DC-75/ DC-78/ DC-70S Diagnostic Ultrasound

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Ultrasound System is applicable for adults,pregnant women, pediatric patients andneonates. It is intended for use in fetal,abdominal, pediatric, small organ(breast,thyroid, testes), neonatal and adult cephalic,trans-rectal, trans-vaginal,musculo-skeletal(conventional, superficial),adult and pediatric cardiac, Trans-esoph.(Cardiac), peripheral vessel and urologyexams.	System is applicable for adults, pregnantwomen, pediatric patients and neonates. It isintended for use in fetal, abdominal, pediatric,small organ(breast, thyroid, testes), neonatal andadult cephalic, trans-rectal, trans-vaginal,musculo-skeletal(conventional, superficial),adult and pediatric cardiac, Trans-esoph.(Cardiac), peripheral vessel and urologyexams.
intra-operative(abdominal, thoracic, andvascular)	intra-operative(abdominal, thoracic, andvascular)(DC-80 K173471)

The acoustic power levels of DC-70/ DC-70T/ DC-70 Pro/DC-70 Exp / DC-75/ ● DC-78/ DC-70S are below the limits of FDA, which is the same as the predicated device DC-70(K163690).
. DC-70/ DC-70T/ DC-70 Pro/DC-70 Exp / DC-75/ DC-78/ DC-70S is designed in compliance with the FDA recognized electrical and physical safety standard, which is the same as the predicated device DC-70(K163690).
DC-70/ DC-70T/ DC-70 Pro/DC-70 Exp / DC-75/ DC-78/ DC-70S has similar probes as the predicated device:

Subject device	Predicated device
DC-70/ DC-70T/ DC-70 Pro/DC-70 Exp /DC-75/ DC-78/ DC-70S
L14-5WE	L14-5WE & DC-80 (K173471)
L20-5E	L20-5U& Resona 7 (K171233)
6LB7E	6LB7s& M6(K171579)
SC6-1E	SC6-1U& Resona 7 (K171233)
SD8-1E	D6-2E&DC-70(K163690)
L16-4HE	L16-4HE& DC-80 (K173471)

7. Non-clinical Tests:

DC-70/ DC-70T/ DC-70 Pro/DC-70 Exp/ DC-78/ DC-78/ DC-70S Diagnostic

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Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been designed to conform with applicable medical safety standards. This device has been tested and evaluated under the following standards:

AAMI/ANSI ES60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance
AAMI/ANSI/IEC 60601-1-2: Medical electrical equipment Part 1-2: General ● requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3)
IEC 60601-2-37: Medical electrical equipment Part 2-37: Particular requirements . for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
IEC 62304: Medical device software Software life cycle processes ●
IEC:62366:Medical devices - application of usability engineering to medical devices
IEC 60601-1-6: medical electrical equipment part 1-6: general requirements for ● basic safety and essential performance - collateral standard: usability.
ISO14971: Medical devices - Application of risk management to medical devices
UD 2: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
. UD 3 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
. ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

These non-clinical tests relied on in this premarket notification submission can support the determination of substantial equivalence of the subject device.

8. Clinical Studies

Not applicable. The subject of this submission, DC-70/ DC-70T/ DC-70 Pro/ DC-70 Exp / DC-75/ DC-78/ DC-70S Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.

Conclusion:

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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-70/ DC-70T/ DC-70 Pro/ DC-70 Exp / DC-75/ DC-78/ DC-70S Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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.