DC-60/DC-60S/DC-60 Exp/DC-55 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. peripheral vessel and urology exam.

Device Description

The DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System is a general purpose, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW-mode, Color-Mode, Power/Dirpower Mode, THI, contrast imaging (contrast agent for LVO), iScape, Color M, TDI, 3D/4D mode, Elastography 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.

AI/ML Overview

This summary details the DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System, which is a general-purpose, software-controlled device. The information provided outlines the system's intended uses, various application modes, and different transducers. The document explicitly states that clinical studies were not required or conducted for this 510(k) submission to support substantial equivalence. Therefore, I cannot provide information on acceptance criteria based on clinical performance, a study to prove meeting acceptance criteria in a clinical context, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance.

However, the submission does refer to non-clinical tests and standards to support substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

The acceptance criteria for non-clinical performance are based on compliance with recognized FDA standards. The reported device performance is that the device conforms to these standards.

Acceptance Criteria (Standard Compliance)	Reported Device Performance
AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod).	Device conforms to the standard.
IEC 60601-1-2 Edition 3: 2007-03, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.	Device conforms to the standard.
IEC 60601-2-37 Edition 2.0 2007, Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.	Device conforms to the standard.
IEC 62304 Edition 1.1 2015-06, medical device software - software life cycle processes.	Device conforms to the standard.
ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices.	Device conforms to the standard.
NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic ultrasound equipment revision 3.	Device conforms to the standard (acoustic power levels are below FDA limits).
AAMI / ANSI / ISO 10993-1:2009/(R)2013, biological evaluation of medical devices - part 1: evaluation and testing within a risk management process.	Device conforms to the standard (biocompatibility).
Cleaning and disinfection effectiveness standards (specific standard not explicitly listed, but mentioned for conformance)	Device conforms to applicable standards.
Thermal, electrical and mechanical safety standards (specific standards not explicitly listed beyond 60601-1, but mentioned for conformance)	Device conforms to applicable standards.

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

Sample Size for Test Set: Not applicable for clinical performance based on the document. For non-clinical tests, the "sample size" refers to the tested device components and systems, which are assumed to be representative of the manufactured product. Specific quantities are not provided, but the testing would have been conducted on a sufficient number of units to demonstrate compliance with the referenced standards.
Data Provenance: The tests are non-clinical and conducted by the manufacturer, Shenzhen Mindray Bio-medical Electronics Co., LTD, in Shenzhen, Guangdong, China. The data would be prospective, generated specifically for this submission.

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

Not applicable in the context of clinical performance, as no clinical studies were performed. For non-clinical engineering and safety tests, the "ground truth" is established by the validated methods outlined in the respective standards. The expertise would lie with the engineers and technicians performing the tests and validating the equipment according to these standards.

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

Not applicable for clinical performance. For non-clinical tests, adjudication methods like 2+1 or 3+1 are not typically used. Compliance is generally determined by whether the device meets the pass/fail criteria of the specified technical standards.

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:

No MRMC comparative effectiveness study was done. The document explicitly states: "The subject of this submission... does not require clinical studies to support substantial equivalence."

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

Not applicable as an AI algorithm for clinical decision-making is not mentioned as a core component of this ultrasound system's substantial equivalence claim in the provided text. The device is described as an "ultrasonic diagnostic system" with software control and various imaging modes, not an AI for interpretation.

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

Not applicable for clinical performance. For non-clinical tests, the "ground truth" is typically the established physical or electrical properties measured against the specifications and limits defined by industry standards (e.g., acoustic output measurements, EMI limits, biocompatibility profiles).

8. The sample size for the training set:

Not applicable, as no AI/machine learning algorithm requiring a training set for clinical interpretation is described or validated in this submission for substantial equivalence.

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

Not applicable, as there is no mention of a training set or AI/machine learning algorithm for clinical interpretation.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 10, 2019

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

Re: K182636

Trade/Device Name: DC-60/DC-60S/DC-60 Exp/DC-55 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 Dated: December 26, 2018 Received: December 28, 2018

Dear Jiang Haosen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 807); labeling (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.html; 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 medical devices and radiation-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,

Hse 2. Nils

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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K182636

Device Name

DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

[X] Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Diagnostic Ultrasound Indications For Use Format

DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System System:

Transducer: N/A

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	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
	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	P	P	P	P	P	P	P	Note 1, 2,4,6,7
Fetal Imaging &	Adult Cephalic	P	P	P	P	P	P	P	Note 1, 2,4,6,7
Other	Trans-rectal	P	P	P		P	P	P	Note 1, 2,3,4,6,7
	Trans-vaginal	P	P	P		P	P	P	Note 1, 2,3,4,6,7
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P	P	P		P	P	P	Note 1,2,4,7,8
	Musculo-skeletal(Superficial)	P	P	P		P	P	P	Note 1, 2,4,7,8
	Intravascular
	Cardiac Adult	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7,9
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7,9
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel	P	P	P	P	P	P	P	Note 1, 2,4,6,7
vessel	Other (Specify***)	N	N	N	N	N	N	N	Note 1, 2,4,7
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular
	** 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
	Note9: 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		Mode of Operation
General (Track1 Only)	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	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic
Other	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	P	P	P		P	P	P	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、PW +Color+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. 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
	Note9: Contrast imaging(contrast agent for LVO)
	(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
	Abdominal	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
Fetal Imaging &	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
	(Conventional)
	Musculo-skeletal
	(Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2, 4,6,7
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel	P	P	P	P	P	P	P	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
	Note9: Contrast imaging(contrast agent for LVO)
	(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
	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
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic
Other	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	P	P	P		P	P	P	Note 1, 2, 4,7,8
	(Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel	P	P	P		P	P	P	Note 1, 2, 4,7
vessel	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix EAdditional 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: Smart3DNote 3:4D(Real-time 3D)Note 4: iScapeNote5: TDINote6: Color MNote7: Biopsy GuidanceNote8: ElastographyNote9: Contrast imaging(contrast agent for LVO)(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
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1, 2, 4,7
	Small Organ (Specify**)	P	P	P	P	P	P	P	Note 1, 2, 4,7,8
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P	P	P	P	P	P	P	Note 1, 2, 4,7,8
	Musculo-skeletal(Superficial)	P	P	P	P	P	P	P	Note 1, 2, 4,7,8
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel	P	P	P	P	P	P	P	Note 1,2, 4,7
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
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note9: Contrast imaging(contrast agent for LVO)
	(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	P	P	P		P	P	P	Note 1, 2, 4,6,7
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
Fetal Imaging &Other	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	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
	Other (Specify***)	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
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	P	P	P		P	P	P	Note 1, 2, 4,6,7
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
Fetal Imaging &Other	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
	Other (Specify***)	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
	Note5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note9: Contrast imaging(contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)

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

3C5A

System: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

Transducer: 3C5A

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

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

6C2

System: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

Transducer: 6C2

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

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

7L4A

System: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

Transducer: 7L4A

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

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

L14-6NE

System: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

Transducer: L14-6NE

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

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

V11-3

System: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

V11-3 Transducer:

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

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

V11-3B

System: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

Transducer: V11-3B

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

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

P4-2

System: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

Transducer: P4-2

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

Intended Use:Clinical Application		Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:Mode of Operation
General (Track1 Only)	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
	Small Organ (Specify**)
	Neonatal Cephalic
Fetal Imaging &Other	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, 2,4,5,6,7,9
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,5,6,7,9
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
	Note9: Contrast imaging(contrast agent for LVO)
	(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
	Abdominal	P	P	P	P	P	P	P	Note 1, 2,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1, 2,6
Fetal Imaging &	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
Cardiac	Intravascular
	Cardiac Adult
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2,5,6
	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: iScapeNote5: TDI
	Note6: Color M
	Note7: Biopsy Guidance
	Note8: Elastography
	Note9: Contrast imaging(contrast agent for LVO)(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
General (TrackAmplitudeColorCombinedSpecific (Track 1 & 3)BPWDCWDMOther (specify)1 Only)DopplerDoppler(specify)OphthalmicOphthalmicFetalPPPPPPNote 1, 2, 3, 4, 6AbdominalPPPPPbNote 1, 2, 3, 4, 6Intra-operative (Specify)Intra-operative (Neuro)LaparoscopicPediatricSmall Organ (Specify)Neonatal CephalicFetal Imaging &Adult CephalicOtherTrans-rectalTrans-vaginalTrans-urethralTrans-esoph. (non-Card.)Musculo-skeletal(Conventional)Musculo-skeletal(Superficial)IntravascularCardiac AdultCardiac PediatricCardiacIntravascular (Cardiac)Trans-esoph. (Cardiac)Intra-cardiacPeripheral vesselPeripheralvesselOther (Specify*)N=new indication; P=previously cleared by FDA;E=added under Appendix EAdditional comments: Combined modes-B+M. PW+B、Color + B、PW +Color+B、PW +Color+B、Power + PW +B.Intraoperative includes abdominal, thoracic, and vascular etc. Small organ-breast, thyroid, testes.** * Other use includes Urology.Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.Note 2: Smart3DNote 3:4D(Real-time 3D)Note 4: iScapeNote5: TDINote6: Color MNote7: Biopsy GuidanceNote8: ElastographyNote9: Contrast imaging(contrast agent for LVO)(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











































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
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic
Other	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; 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
	Note9: Contrast imaging(contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)

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

P7-3

System: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

Transducer: P7-3

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

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

D7-2E

System: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

Transducer: D7-2E

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

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

CW5s

System: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

Transducer: CW5s

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

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

CW2s

System: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

Transducer: CW2s

	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
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
	(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Cardiac Adult				P
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel
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
	Note9: Contrast imaging(contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)

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

C6-2

System: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

Transducer: C6-2

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	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
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	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
	Note9: Contrast imaging(contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)

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

L9-3E

System: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

Transducer: L9-3E

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, 4,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1,2, 4,7
	Small Organ (Specify**)	N	N	N		N	N	N	Note 1,2, 4,7,8
	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, 4,7,8
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	Note 1,2, 4,7,8
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	N	N	N		N	N	N	Note 1,2, 4,7
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix EAdditional 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: Smart3DNote 3:4D(Real-time 3D)Note 4: iScapeNote5: TDINote6: Color MNote7: Biopsy GuidanceNote8: ElastographyNote9: Contrast imaging(contrast agent for LVO)(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)Concurrence of CDRH, Office of Device Evaluation(ODE)

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

L14-6WE

System: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

Transducer: L14-6WE

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, 4,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1,2, 4,7
	Small Organ (Specify**)	N	N	N		N	N	N	Note 1,2, 4,7, 8
	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, 4,7,8
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	Note 1,2, 4,7,8
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	N	N	N		N	N	N	Note 1,2, 4,7
	Other (Specify***)
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***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
Note9: Contrast imaging(contrast agent for LVO)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)

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

L13-3

System: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

Transducer: L13-3

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	N	Note 1, 2, 4,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1, 2, 4,7
	Small Organ (Specify**)	N	N	N	N	N	N	N	Note 1,2, 4,7, 8
	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, 4,7,8
	Musculo-skeletal(Superficial)	N	N	N	N	N	N	N	Note 1, 2, 4,7,8
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	N	N	N	N	N	N	N	Note 1, 2, 4,7
	Other (Specify***)
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power + PW +B.
* Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes.
*** 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
	Note9: Contrast imaging(contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)

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

7L4B

System: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

Transducer: 7L4B

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	N	Note 1, 2, 4,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1, 2, 4,7
	Small Organ (Specify**)	N	N	N	N	N	N	N	Note 1, 2, 4,7
	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, 4,7
	Musculo-skeletal(Superficial)	N	N	N	N	N	N	N	Note 1, 2, 4,7
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	N	N	N	N	N	N	N	Note 1, 2, 4,7
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color+B、Power+B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular etc.
	**Small organ-breast, thyroid, testes.
	***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
	Note9: Contrast imaging(contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)

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

DE10-3E

System: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

Transducer: DE10-3E

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	N	N	N		N	N	N	Note 1, 3, 4, 6,7
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N		N	N	N	Note 1, 3, 4, 6,7
	Trans-vaginal	N	N	N		N	N	N	Note 1, 3, 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
Peripheral	Peripheral vessel
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
	Note9: Contrast imaging(contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)

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

P10-4E

System: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

Transducer: P10-4E

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 &	Fetal
Other	Abdominal	N	N	N	N	N	N	N	Note 1, 2,4,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1, 2,4,6
	Small Organ (Specify**)
	Neonatal Cephalic	N	N	N	N	N	N	N	Note 1, 2,4,6
	Adult Cephalic	N	N	N	N	N	N	N	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	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
Peripheral	Peripheral vessel
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
	Note9: Contrast imaging(contrast agent for LVO)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)

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

510(K) SUMMARY

K182636

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).

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 6183 Fax: +86 755 2658 2680

Contact Person:

Jiang Haosen Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Shenzhen, Guangdong, 518057, P. R. China jianghaosen@mindray.com

Date Prepared: 2018-09-14

2. Device Name: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System Classification

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

3. Device Description:

The DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System is a general

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

purpose, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW-mode, Color-Mode, Power/Dirpower Mode, THI, contrast imaging (contrast agent for LVO), iScape, Color M, TDI, 3D/4D mode, Elastography 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.

4. Intended Use:

5. Summary of Modifications

New added Transducers: DE10-3E P10-4E C6-2 L9-3E L13-3 L14-6WE 7L4B .
New added Needle-Guided Brackets NGB-021, NGB-022, NGB-034

. Main added Features

iLive, Smart Volume, SCV+, STIC, Color 3D, Niche, iPage+, LVO, Smart Planes CNS, Auto EF, Smart FLC, Contrast Imaging QA, Tissue Tracking QA. Added the elastography function to 7L4A, L14-6NE, L9-3E, L14-6WE, L13-3. Added the contrast imaging (contrast agent for LVO) function to P4-2.

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. Indications For Use
Added clinical application Urology to V11-3 and V11-3B.

6. Comparison with Predicate Devices:

DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

Predicate Device	Manufacturer	Model	510(k) ControlNumber
1.Primary predicate device	Mindray	DC-60	K152545
2.Reference device	Mindray	DC-8	K170277
3.Reference device	Mindray	DC-80	K173471
4.Reference device	Mindray	Resona 7	K171233
5.Reference device	Mindray	M9	K171034
6.Reference device	Mindray	ZS3	K171891

Compared to the predicate devices DC-60 (K152545):

. DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System employs the same technology as the predicate devices. All systems transmit ultrasonic energy into patients, then 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. The subject device also has the same intended uses and basic operating modes as the predicate devices.
Subject device DC-60/DC-60S/DC-60 Exp/DC-55 has the same intended uses as the predicated device DC-60/DC-60S/DC-60 Exp/DC-55 (K152545); urology exam as the predicated device DC-80 (K173471).
The patient contact materials of the new added probes and Needle-guided brackets of DC-60/DC-60S/DC-60 Exp/DC-55 are the same to the probes and Needle-guided brackets of predicate device.
. The acoustic power levels of DC-60/DC-60S/DC-60 Exp/DC-55 are below the limits of FDA, which is the same as the predicated device DC-60/DC-60S/DC-60 Exp/DC-55 (K152545).
. DC-60/DC-60S/DC-60 Exp/DC-55 is designed in compliance with the FDA recognized

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electrical and physical safety standards, which are the same as the predicated device DC-60/DC-60S/DC-60 Exp/DC-55 (K152545).

The new added features of DC-60/DC-60S/DC-60 Exp/DC-55 are the same as the predicated devices.

7. Non-clinical Tests:

DC-60/DC-60S/DC-60 Exp/DC-55 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.

Non-clinical tests relied on in this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards:

AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod).
. IEC 60601-1-2 Edition 3: 2007-03, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
. IEC 60601-2-37 Edition 2.0 2007, Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
. IEC 62304 Edition 1.1 2015-06, medical device software - software life cycle processes.
. ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices.
. NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic ultrasound equipment revision 3.
. AAMI / ANSI / ISO 10993-1:2009/(R)2013, biological evaluation of medical devices - part 1: evaluation and testing within a risk management process.

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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-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.

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-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

Regulation Number and Section

N/A