Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System

• K Number: K200411
• Device Name: Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
• Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., LTD.
• Date Cleared: 2020-04-08 ( 49 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K183377 , K182603
• Predicate For: N/A

Intended Use

The Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative (abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculoskeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel, and urology exam.

Device Description

The Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode , Power/Dirpower Mode, 4D, Smart3D,TDI, Color M, Elastography, Biopsy Guidance, Contrast imaging (Contrast agent for Liver) 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 probe.

AI/ML Overview

The provided text is a 510(k) Pre-market Notification from the FDA, and it does not contain information about a study that proves the device meets specific acceptance criteria in the way a clinical performance study for an AI/ML-driven device would. This document pertains to traditional diagnostic ultrasound systems.

Specifically, it states multiple times:

• "Not applicable. The subject of this submission, Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." (Page 26, Section 8. Clinical Studies)
• "The Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System 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." (Page 25, Section 6. Comparison with Predicate Devices)

Therefore, based on the provided document, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets those criteria, as an AI/ML performance study was not conducted or required for this conventional diagnostic ultrasound system.

The document focuses on demonstrating substantial equivalence to already legally marketed predicate devices, primarily the Mindray Z6 (K182603) and DC-40 (K183377), by showing:

• Same intended uses: The document lists "fetal, abdominal, intra-operative (abdominal, thoracic, and vascular), 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 exams." (Page 24)
• Similar technological characteristics and operating modes: B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, 4D, Smart3D, TDI, Color M, Elastography, Biopsy Guidance, Contrast imaging (for liver). (Page 23)
• Compliance with recognized safety standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, IEC 62366, IEC 60601-1-6, ISO 14971, ISO 10993-1. (Page 25-26)
• Acoustic power levels below FDA limits. (Page 25)

The concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" as it relates to AI/ML performance (e.g., specific sensitivity, specificity, or AUC targets, or human-in-the-loop improvement metrics) is not relevant to this type of traditional device submission. The "acceptance criteria" here are implicitly meeting the performance characteristics and safety standards of the predicate devices.

Summary

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April 8, 2020

ShenZhen Mindray Bio-Medical Electronics Co., Ltd. % Shi Jufang Engineer of Technical Regulation Mindray Building, Keji 12th Road South Hi-Tech Industrial Park Shenzhen, Guangdong 518057 CHINA

Re: K200411

Trade/Device Name: Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 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: February 12, 2020 Received: February 19, 2020

Dear Shi Jufang:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality 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)

K200411

Device Name

Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System

Indications for Use (Describe)

The Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative (abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculoskeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel, and urology exam.

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

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Diagnostic Ultrasound System Indications For Use Format
System:	Z6/Z60/Z60T/Z60S/Z60 Pro Diagnostic Ultrasound 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	Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal	P	P	P		P	P	P	Note 1,2,5,6,7
	Abdominal	P	P	P	P	P	P	P	Note1,2,3,4,5,6,7,9
	Intra-operative (Specify*)	P	P	P		P	P	P	Note 1,2,3,6
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1,2,3,4,5,6
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2,3,6,8
	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,2,3,4,5,6
	Adult Cephalic	P	P	P	P	P	P	P	Note 1,2,4,5,6
	Trans-rectal	P	P	P		P	P	P	Note 1,2,5,6
	Trans-vaginal	P	P	P		P	P	P	Note 1,2,5,6
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P	P	P	P	P	Note 1,2,3,4,5,6,8
	Musculo-skeletal (Superficial)	P	P	P		P	P	P	Note 1,2,3,6,8
	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	P	P	P		P	P	P	Note 1,2,3,5,6
	Other (Specify***)	P	P	P		P	P	P	Note 1,2,5,6
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note 5: Color M
	Note 6: Smart3D
	Note 7:4D(Real-time 3D)
	Note 8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)(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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Diagnostic Ultrasound System Indications For Use Format
System:	DP-60 Diagnostic Ultrasound 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	Specific (Track 1 & 3)	B	M	PW D	CW D	Color Doppler	Amplitude Doppler	Combined (specify)	Other (Specify)
(Track 1 Only)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal	N	N	N	N	N	N	N	Note 1,2,5,6
	Abdominal	N	N	N	N	N	N	N	Note 1,2,3,4,5,6,9
	Intra-operative (Specify*)	N	N	N	N	N	N	N	Note 1,2,3,6
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1,2,3,4,5,6
	Small Organ (Specify**)	N	N	N	N	N	N	N	Note 1,2,3,6,8
	Neonatal Cephalic	N	N	N	N	N	N	N	Note 1,2,3,4,5,6
	Adult Cephalic	N	N	N	N	N	N	N	Note 1,2,4,5,6
	Trans-rectal	N	N	N	N	N	N	N	Note 1,2,5,6
	Trans-vaginal	N	N	N	N	N	N	N	Note 1,2,5,6
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	N	N	N	N	N	N	N	Note 1,2,3,4,5,6,8
	Musculo-skeletal (Superficial)	N	N	N	N	N	N	N	Note 1,2,3,6,8
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	N	N	N	N	N	N	N	Note 1,2,3,5,6
	Other (Specify***)	N	N	N	N	N	N	N	Note 1,2,5,6
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note 5: Color M
	Note 6: Smart3D
	Note 7:4D(Real-time 3D)
	Note 8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	(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:	Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
Transducer:	3C5P
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical ApplicationMode of Operation
General(Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal	P	P	P		P	P	P	Note 1,2,5,6
	Abdominal	P	P	P		P	P	P	Note 1,2,5,6,9
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,5,6
	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 1,2,5,6
	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 1,2,5,6
	Other (Specify***)
	N=new indication; P=previously cleared by FDA;					E=added under Appendix E
	Additional comments: Combined modes-B+M、PW+B、Color + B、Power + B、PW+Color+B、Power +PW+B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	** Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note 5: Color M
	Note 6: Smart3D
	Note 7:4D(Real-time 3D)
	Note 8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Prescription USE (Per 21 CFR 801.109)
System:	Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
Transducer:	C6-2P
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical ApplicationMode of Operation
General(Track 1 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 1,2,5,6
	Abdominal	N	N	N		N	N	N	Note 1,2,5,6,9
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1,2,5,6
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	Note 1,2,5,6
	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	Note 1,2,5,6
	Other (Specify***)
	N=new indication; P=previously cleared by FDA;					E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW+B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	** Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note 5: Color M
	Note 6: Smart3D
	Note 7:4D(Real-time 3D)
	Note 8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Prescription USE (Per 21 CFR 801.109)
System:	Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
Transducer:	6C2P
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
General(Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2,5,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,5,6
Small Organ (Specify**)
	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2,5,6
	Adult Cephalic	P	P	P		P	P	P	Note 1,2,5,6
	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
	Other (Specify***)
System:	Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
Transducer:	6CV1P
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	P	P	P		P	P	P	Note 1,2,5,6
	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 1,2,5,6
	Trans-vaginal	P	P	P		P	P	P	Note 1,2,5,6
	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 1,2,5,6
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
		Note 5: Color M
	Note 6: Smart3D
	Note 7:4D(Real-time 3D)
	Note 8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Prescription USE (Per 21 CFR 801.109)
System:	Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
Transducer:	7L4P
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	P	P	P		P	P	P	Note 1,2,3,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,3,6
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2,3,6,8
	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2,3,6
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P	P	P		P	P	P	Note 1,2,3,6,8
	Musculo-skeletal (Superficial)	P	P	P		P	P	P	Note 1,2,3,6,8
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,3,6
	Other (Specify***)
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging.
Note 2: Biopsy Guidance
Note 3: iScape
Note 4: TDI
Note 5: Color M
Note 6: Smart3D
Note 7:4D(Real-time 3D)
Note 8: Strain Elastography
Note 9: Contrast imaging (Contrast agent for Liver)
(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:	Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
Transducer:	7L4BP
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	N	N	N		N	N	N	Note 1,2,3,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1,2,3,6
	Small Organ (Specify**)	N	N	N		N	N	N	Note 1,2,3,6,8
	Neonatal Cephalic	N	N	N		N	N	N	Note 1,2,3,6
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	Note 1,2,3,6,8
	Musculo-skeletal (Superficial)	N	N	N		N	N	N	Note 1,2,3,6,8
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	N	N	N		N	N	N	Note 1,2,3,6
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note 5: Color M
	Note 6: Smart3D
	Note 7:4D(Real-time 3D)
	Note 8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Prescription USE (Per 21 CFR 801.109)
System:	Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
Transducer:	7L5P
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	P	P	P		P	P	P	Note 1,2,3,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,3,6
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2,3,6
	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2,3,6
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P	P	P		P	P	P	Note 1,2,3,6
	Musculo-skeletal(Superficial)	P	P	P		P	P	P	Note 1,2,3,6
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,3,6
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+ B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
		Note 5: Color M
		Note 6: Smart3D
		Note 7:4D(Real-time 3D)
		Note 8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	(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:	Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
Transducer:	L14-6P
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	P	P	P		P	P	P	Note 1,2,3,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,3,6
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2,3,6
	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2,3,6
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P	P	P		P	P	P	Note 1,2,3,6
	Musculo-skeletal(Superficial)	P	P	P		P	P	P	Note 1,2,3,6
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,3,6
	Other (Specify***)
	N=new indication; P=previously cleared by FDA;				E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+ B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	** Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
Note 5: Color M
Note 6: Smart3D
Note 7:4D(Real-time 3D)
	Note 8: Strain Elastography
	Contrast imaging (Contrast agent for Liver)Note 9:
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription USE (Per 21 CFR 801.109)
System:	Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
Transducer:	CB10-4P
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	P	P	P		P	P	P	Note 1,2,5,6
	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***)	P	P	P		P	P	P	Note 1,2,5,6
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+ B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note 5: Color M
	Note 6: Smart3D
	Note 7:4D(Real-time 3D)
	Note 8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	(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:	Z6/Z60/Z60T/Z60S/Z60 Pro Diagnostic Ultrasound System
Transducer:	2P2P
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	P	P	P	P	P	P	P	Note 1,2,4,5,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1,2,4,5,6
	Small Organ (Specify**)
	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,2,4,5,6
	Adult Cephalic
	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;				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: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
Note 5: Color M
Note 6: Smart3D
	Note 7:4D(Real-time 3D)
	Note 8: Strain Elastography
	Contrast imaging (Contrast agent for Liver)Note 9:
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription USE (Per 21 CFR 801.109)
System:	Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
Transducer:	V10-4BP
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	P	P	P		P	P	P	Note 1,2,5,6
	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 1,2,5,6
	Trans-vaginal	P	P	P		P	P	P	Note 1,2,5,6
	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 1,2,5,6
	N=new indication; P=previously cleared by FDA;				E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color +B、Power+B、PW+Color+B、Power +PW +B.*Intraoperative includes abdominal, thoracic, and vascular.
	** Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note 5: Color M
	Note 6: Smart3D
	Note 7:4D(Real-time 3D)
	Note 8: Strain Elastography
	Contrast imaging (Contrast agent for Liver)Note 9:
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

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

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

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

System:	Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
Transducer:	7LT4P
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	P	P	P		P	P	P	Note 1,2,3,6
	Intra-operative (Specify*)	P	P	P		P	P	P	Note 1,2,3,6
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,3,6
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2,3,6
	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2,3,6
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P	P	P		P	P	P	Note 1,2,3,6
	Musculo-skeletal (Superficial)	P	P	P		P	P	P	Note 1,2,3,6
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,3,6
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
		Note 5: Color M
		Note 6: Smart3D
	Note 7:4D(Real-time 3D)
	Note 8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

System:	Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
Transducer:	6LE7P
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	P	P	P		P	P	P	Note 1,2,5,6
	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***)	P	P	P		P	P	P	Note 1,2,5,6
	N=new indication; P=previously cleared by FDA;				E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+ B、Power + PW +B.*Intraoperative includes abdominal, thoracic, and vascular.
	** Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
	Note 5: Color M
	Note 6: Smart3D
	Note 7:4D(Real-time 3D)
	Note 8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	(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:	Z6/Z60/Z60T/Z60S/Z60 Pro Diagnostic Ultrasound System
Transducer:	P7-3P
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	P	P	P	P	P	P	P	Note 1,2,4,5,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1,2,4,5,6
	Small Organ (Specify**)
	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,2,4,5,6
	Adult Cephalic	P	P	P	P	P	P	P	Note 1,2,4,5,6
	Trans-rectal
	Trans-vaginal
	Trans-urethral
Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P	P	P	P	P	P	P	Note 1,2,4,5,6
	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; 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: Biopsy Guidance
	Note 3: iScape
Note 4: TDI
Note 5: Color M
	Note 6: Smart3D
	Note 7:4D(Real-time 3D)
	Note 8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for Liver)
	(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:	Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
Transducer:	35C50P
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	P	P	P		P	P	P	Note 1,2,5,6
	Abdominal	P	P	P		P	P	P	Note 1,2,5,6,9
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,5,6
	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 1,2,5,6
	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 1,2,5,6
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Biopsy Guidance
	Note 3: iScape
	Note 4: TDI
Note 5: Color M
Note 6: Smart3D
	Note 7:4D(Real-time 3D)
	Note 8: Strain Elastography
	Contrast imaging (Contrast agent for Liver)Note 9:
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Prescription USE (Per 21 CFR 801.109)
System:	Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
Transducer:	75L38P
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	P	P	P		P	P	P	Note 1,2,3,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,3,6
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2,3,6,8
	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2,3,6
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P	P	P		P	P	P	Note 1,2,3,6,8
	Musculo-skeletal (Superficial)	P	P	P		P	P	P	Note 1,2,3,6,8
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,3,6
	Other (Specify***)
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging.
Note 2: Biopsy Guidance
Note 3: iScape
Note 4: TDI
Note 5: Color M
Note 6: Smart3D
Note 7:4D(Real-time 3D)
Note 8: Strain Elastography
Note 9: Contrast imaging (Contrast agent for Liver)
(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:	Z6/Z60/Z60T/Z60S/Z60 Pro Diagnostic Ultrasound System
Transducer:	D6-2P
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)
Ophthalmic	Ophthalmic
FetalImaging &Other	Fetal	P	P	P		P	P	P	Note 1,2,5,7
	Abdominal	P	P	P		P	P	P	Note 1,2,5,7
	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
	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: Biopsy Guidance
Note 3: iScape
Note 4: TDI
Note 5: Color M
Note 6: Smart3D
Note 7:4D(Real-time 3D)
Note 8: Strain Elastography
Note 9: Contrast imaging (Contrast agent for Liver)
(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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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:

1. Submitter:

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China Tel: [phone] Fax: [phone]

Contact Person:

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

Date Prepared: February 12, 2020

2. Device Name: Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System Classification

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

3. Device Description:

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The Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode , Power/Dirpower Mode, 4D, Smart3D,TDI, Color M, Elastography, Biopsy Guidance, Contrast imaging (Contrast agent for Liver) 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 probe.

4. Intended Use:

The Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intraoperative (abdominal, thoracic, and vascular), 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 exams.

5. Summary of Modifications

• . Newly Added Models: Z60、Z60T、Z60S、Z60 Pro、DP-60;
• . Newly Added Transducers: C6-2P、7L4BP:
• . Newly Added Needle-guided Brackets: NGB-022;
• Main Added Features and Modifications:
  • 1. Appearance change;
  • 2. Add host with three probe board;
  • 3. Add Smart Face;
  • 4. Add Smart OB:
  • 5. Add mobile trolley UMT-170;
  • 6. Add function of transducer element check.

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6. Comparison with Predicate Devices:

The Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

Predicate Device	Manufacturer	Model	510(k) Number	Control
1. Primary predicate device	Mindray	Z6	K182603
2. Reference device	Mindray	DC-40	K183377

The Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System 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
  The Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System has the same intended uses as the predicated device Z6 (K182603)

Subject Device	Predicate device
The Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60	Z6 (K182603)
The Diagnostic Ultrasound System is	The Diagnostic Ultrasound System is
applicable for adults, pregnant women,	applicable for adults, pregnant women,
pediatric patients and neonates. It is intended	pediatric patients and neonates. It is intended
for use in fetal, abdominal,	for use in fetal, abdominal,
intraoperative (abdominal, thoracic, and	intraoperative(abdominal, thoracic, and
vascular), pediatric, small organ (breast,	vascular), pediatric, small organ(breast,
thyroid, testes), neonatal and adult cephalic,	thyroid, testes), neonatal and adult cephalic,
trans-rectal, trans-vaginal,	trans-rectal, trans-vaginal,
musculo-skeletal(conventional, superficial),	musculo-skeletal(conventional, superficial),

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Note: The DP-60 does not have adult and pediatric cardiac application, but other models have the application.

• . The acoustic power levels of Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 are below the limits of FDA, which is the same as the predicated device Z6 (K182603)
• . The Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 is designed in compliance with the FDA recognized electrical and physical safety standard, which is the same as the predicated device Z6 (K182603)

The Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 has similar probes as the predicated device.

7. Non-clinical Tests:

The Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 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 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
• . 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
• ISO 10993-1: Biological evaluation of medical devices -- Part 1: Evaluation and ●

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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, Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 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 Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

Regulation Number and Section

N/A