The ZS3 and z.one pro Ultrasound Systems are intended for use by a qualified physician for ultrasound evaluation of Opthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic(cardiac), and vascular); Intraoperative (Neuro); Pediatric; Small organ (thyroid, breast, testes, etc); Neonatal cephalic/Transcrania; Trans-rectal; Trans-vaginal; Trans-esoph.(non-Card); Musculoskeletal(Conventional); Musculoskeletal(Superticial); Cardiac Adult; Cardiac Pediatric; Trans-esoph. (Cardiac); Intra-cardiac; Peripheral vessel.

Device Description

The ZS3 and z.one pro Ultrasound Systems are full-featured, general purpose, software controlled, diagnostic ultrasound systems used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. The system utilizes zone technology which allows the system to collect more data at one time, thereby optimizing image quality. The exam dependent default settings for the ZS3 and z.one pro allow the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control enables the advanced user to set the system based on image appearance preference. The architecture of the ZS3 and z.one pro Ultrasound Systems support system integration to a variety of upgradable options and features. Up to three transducers can be connected to the multi-transducer port permitting easy transducer transition. The system can be operated on either battery or AC power.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the ZS3 and z.one pro Ultrasound Systems.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ZS3 and z.one pro Ultrasound Systems are primarily defined by their adherence to various medical safety standards and their demonstrated substantial equivalence to previously cleared predicate devices. The reported device performance is based on successful compliance with these standards and the equivalence established through non-clinical testing.

Here's a breakdown of the acceptance criteria (standards met) and reported performance (compliance):

Acceptance Criteria (Standards Met)	Reported Device Performance (Compliance)
Safety Standards:
- AAMI/ANSI ES60601-1 (Basic safety and essential performance)	ZS3 and z.one pro Ultrasound Systems conform to this standard for electrical and physical safety.
- IEC 60601-1-2 (Electromagnetic compatibility)	ZS3 and z.one pro Ultrasound Systems conform to this standard.
- IEC 60601-2-37 (Ultrasonic medical diagnostic and monitoring equipment)	ZS3 and z.one pro Ultrasound Systems conform to this standard for basic safety and essential performance of ultrasonic equipment.
- ISO 10993-1 (Biological evaluation of medical devices)	Patient contact materials of new added transducers and needle-guided bracket are tested under and conform to this standard.
- Acoustic output levels below FDA limits (UD 2, UD 3)	The acoustic power levels of modified ZS3 and z.one pro are below the limits of FDA, which are the same as the predicate device ZS3 and z.one pro (K151175). Real-time display of thermal and mechanical acoustic output indices is compliant.
Software Standards:
- IEC 62304 (Medical device software life cycle processes)	The design, development, and quality processes confirm with the requirements of this standard.
Risk Management Standards:
- ISO14971 (Application of risk management to medical devices)	The design, development, and quality processes confirm with the requirements of this standard.
Functional Equivalence:
- Same intended use as predicate device (K151175)	The subject device has the same intended use as the predicate device ZS3/z.one pro (K151175), covering a broad range of clinical applications (Ophthalmic, Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal/Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-cardiac and cardiac), Musculoskeletal, Cardiac Adult/Pediatric, Intra-cardiac, Peripheral vessel).
- Same basic operating modes as predicate devices	The modified ZS3 and z.one pro have the same imaging modes (e.g., B, M, PWD, CWD, Color Doppler, Combined Modes) as the predicate devices.
- New added features are same as predicate devices	Specific new features (ARFI, CEUS for Liver, CEUS for LVO, Smart OB, Smart NT, Auto EF, Auto IMT, Stress Echo, Anatomical M, Needle-Guided bracket NGB-022) were compared to predicates.
- Similar transducers with predicate devices	The modified ZS3 and z.one pro have similar transducers as the predicate devices.
Quality Systems:
- 21 CFR 820, ISO 9001, and ISO 13485 quality systems	The design, development, and quality process of the manufacturer conforms with these quality systems.

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

The provided document does not specify a distinct "test set" sample size or data provenance in the context of a clinical study or performance evaluation for the modified ZS3 and z.one pro Ultrasound Systems. The submission relies heavily on non-clinical tests to demonstrate substantial equivalence to previously cleared predicate devices.

The document states:

"Non-clinical tests relied on in this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards." (Refer to the table above for listed standards).
"The subject device has the same intended use as the predicated device ZS3/z.one pro(K151175)"
"The acoustic power levels of modified ZS3 and z.one pro are below the limits of FDA, which are the same as the predicated device ZS3 and z.one pro (K151175)."
"The modified ZS3 and z.one pro are designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device ZS3 and z.one pro (K151175)."

This indicates that the assessment is based on a comparison to established performance and safety profiles of predicate devices and compliance with technical standards, rather than a new clinical study with a specific test cohort of patients. Therefore, there is no direct information on test set sample size or data provenance (e.g., country of origin, retrospective/prospective).

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

Since no dedicated clinical test set is described in the submission as a primary means of demonstrating performance, there is no information provided regarding a number of experts or their qualifications for establishing ground truth. The submission relies on technical compliance and equivalence to predicate devices, which would have undergone clinical validation previously.

4. Adjudication Method for the Test Set

As there is no described clinical test set, there is no information on any adjudication method used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document explicitly states: "Clinical Tests: Not Applicable." This indicates that no MRMC comparative effectiveness study, or any clinical study comparing human readers with and without AI assistance, was performed or presented in this submission.

6. Standalone (Algorithm Only) Performance Study

The document does not describe any standalone performance study of an algorithm without human interaction. The focus is on the ultrasound system and its various features/modes, not a specific AI algorithm delivering a diagnostic output that would require a standalone performance evaluation.

7. Type of Ground Truth Used

Given that the submission primarily relies on non-clinical testing and comparison to predicate devices for substantial equivalence, the "ground truth" implicitly refers to:

Engineering specifications and measurements: For acoustic output, electrical safety, thermal performance, etc.
Biological evaluation standards: For biocompatibility of materials (ISO 10993-1).
Established performance of predicate devices: The functionality and clinical utility are considered equivalent to those of previously cleared devices, which would have undergone their own validation processes (likely clinical studies or expert consensus during their initial clearance).

There is no specific mention of "expert consensus," "pathology," or "outcomes data" as directly used to establish ground truth for this particular submission's performance claim, as it's a modification and comparison to already cleared devices.

8. Sample Size for the Training Set

Since this submission pertains to the modification and substantial equivalence of ultrasound systems and does not describe the development of a specific AI algorithm with a training phase, there is no information on a "training set" sample size. The "new added features" like ARFI and CEUS are functional modalities, not necessarily AI algorithms that require a distinct training set in the way a diagnostic AI would.

Note: If "Smart" features (e.g., Smart OB, Smart NT, Auto EF, Auto IMT) involve AI, the document does not disclose their development or training data.

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

As no training set is described in the context of an AI algorithm, this information is not applicable and not provided in the document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, stacked on top of each other.

September 21, 2017

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

Shenzhen Mindray Bio-Medical Electronics Co., Ltd % Mr. Zhai Pei Engineer of Technical Regulation Department Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen 518057, Guangdong CHINA

Re: K171891

Trade/Device Name: ZS3 and z.one Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: August 15, 2017 Received: August 21, 2017

Dear Mr. Pei:

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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara For

Robert 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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Indications for Use

510(k) Number (if known)

K171891

Device Name ZS3 and z.one pro Ultrasound Systems

Indications for Use (Describe)

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

V Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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System:	ZS3, z.one pro Ultrasound System
Transducer:	System union of all transducer types
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	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic	P		P		P	P
Fetal Imaging& Other	Fetal	P	P	P	P	P	P	P5, P9
	Abdominal6	P	P	P	P	P	P	P5, P9, N11, N12
	Intra-operative (Specify)7	P	P	P		P	P	P5
	Intra-operative (Neuro)	P	P	P		P	P	P5
	Laparoscopic
	Pediatric	P	P	P	P		P	P5, P9
	Small Organ (Thyroid, Breast,Testes, etc.)	P	P	P		P	P	P5, P8
	Neonatal Cephalic	P	P	P	P	P	P	P5
& Other	Adult Cephalic/Transcranial	P	P	P	P	P	P	P5
	Trans-rectal	P	P	P		P	P	P5, P9
	Trans-vaginal	P	P	P		P	P	P5, P9
	Trans-urethral
	Trans-esoph. (non-Card.)	P	P	P	P	P	P	P5
	Musculo-skeletal (Conventional)	P	P	P		P	P	P5, P8
	Musculo-skeletal (Superficial)	P	P	P			P	P5, P8
	Intravascular
Cardiac	Cardiac Adult	P1	P	P	P	P	P	P5, P10
	Cardiac Pediatric	P	P	P	P	P	P	P5, N10
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)	P	P	P	P	P	P	P5, N10
	Intra-cardiac	P	P	P	P	P	P	N10
	Other(Specify)
Peripheralvessel	Peripheral vessel	P	P	P	P	P	P	P5, P8, P9
	Other(Specify)
	N=new system indication; P=previously cleared by FDA;
	1 Includes B-Mode and Harmonic (Contrast) imaging (HI)
	2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
	3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
	4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD)
5 Color M-Mode (CM)	6 Abdominal includes renal, GYN/Pelvic
	7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) )
8 Freehand tissue elasticity
9 3D/4D
	10 CEUS (Contrast agent for LVO)
	11 CEUS (Contrast agent for Liver)
12 ARFI
						Mode of Operation
System:	ZS3, z.one pro Ultrasound System
Transducer:	Curvillinear Transducer C4-1
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application
General(Track1 Only)	Specific(Track 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P
	Abdominal6	P	P	P	P	P	P	N11, N12
	Intra-operative (Specify)7
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P
	Small Organ (Thyroid, Breast,Testes, etc.)
Fetal Imaging& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P		P
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult	P1	P	P	P	P	P	P10
	Cardiac Pediatric
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other(Specify)
Peripheralvessel	Peripheral vessel
	Other(Specify)
N=new system indication; P=previously cleared by FDA;
1 Includes B-Mode and Harmonic (Contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD)
5 Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) )
8 Freehand tissue elasticity
9 3D/4D
10 CEUS (Contrast agent for LVO)
11 CEUS (Contrast agent for Liver)
12 ARFI
						Mode of Operation
System:	ZS3, z.one pro Ultrasound System
Transducer:	Curvillinear Transducer C6-2
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application
General(Track1 Only)	Specific(Track 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P5
	Abdominal6	P	P	P		P	P	P5, N11
	Intra-operative (Specify)7
	Intra-operative (Neuro)
	Laparoscopic
Fetal Imaging& Other	Pediatric	P	P	P		P	P	P5
	Small Organ (Thyroid, Breast,Testes, etc.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other(Specify)
	Peripheral vessel	P	P	P		P	P	P5
	Other (Specify)
	N=new system indication; P=previously cleared by FDA;
	1 Includes B-Mode and Harmonic (Contrast) imaging (HI)
	2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
	3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
	4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD)
5 Color M-Mode (CM)
	6 Abdominal includes renal, GYN/Pelvic
	7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) )
8 Freehand tissue elasticity
9 3D/4D
	10 CEUS (Contrast agent for LVO)
	11 CEUS (Contrast agent for Liver)
12 ARFI
		B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
System:	ZS3, z.one pro Ultrasound System
Transducer:	Curvillinear Transducer C9-3
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	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	p5
	Abdominal6	P	P	P		P	P	P5, N11
	Intra-operative (Specify)7.1, 7.3	P	P	P		P	P	p5
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	p5
	Small Organ (Thyroid, Breast,Testes, etc.)
Fetal Imaging& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P		P	P	p5
	Musculo-skeletal (Superficial)	P	P	P		P	P	p5
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other(Specify)
Peripheralvessel	Peripheral vessel	P	P	P		P	P	p5
	Other (Specify)
	N=new system indication; P=previously cleared by FDA;
	1 Includes B-Mode and Harmonic (Contrast) imaging (HI)
	2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
	3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
	4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD)
5 Color M-Mode (CM)
	6 Abdominal includes renal, GYN/Pelvic
	7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) )
8 Freehand tissue elasticity
9 3D/4D
	10 CEUS (Contrast agent for LVO)
	11 CEUS (Contrast agent for Liver)
12 ARFI

System:	ZS3, z.one pro Ultrasound System
Transducer:	Convex Transducer C10-3
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	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic	P	P	P	CWD	P	P
	Fetal	P	P	P	P	P	P	p5
	Abdominal6	P	P	P	P	P	P	P5, N11
	Intra-operative (Specify)7	P	P	P	P	P	P	p5
	Intra-operative (Neuro)	P	P	P	P	P	P	p5
	Laparoscopic
	Pediatric	P	P	P	P	P	P	p5
Fetal Imaging	Small Organ (Thyroid, Breast,Testes, etc.)
& Other	Neonatal Cephalic	P	P	P	P	P	P	p5
	Adult Cephalic/Transcranial	P	P	P	P	P	P	p5
	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	P5, N10
	Cardiac Pediatric	P	P	P	P	P	P	P5, N10
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other(Specify)
Peripheral	Peripheral vessel	P	P	P	P	P	P	p5
vessel	Other(Specify)
	N=new system indication; P=previously cleared by FDA;
	1 Includes B-Mode and Harmonic (Contrast) imaging (HI)
	2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
	3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
	4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD)
5 Color M-Mode (CM)
	6 Abdominal includes renal, GYN/Pelvic
	7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) )
8 Freehand tissue elasticity
9 3D/4D
	10 CEUS (Contrast agent for LVO)
	11 CEUS (Contrast agent for Liver)
12 ARFI


						Mode of Operation
System:	ZS3, z.one pro Ultrasound System
Transducer:	Curvillinear Transducer C8-3 3D
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application
General(Track1 Only)	Specific(Track 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P5, P9
	Abdominal6	P	P	P		P	P	P5, P9, N11
	Intra-operative (Specify)7
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P5, P9
	Small Organ (Thyroid, Breast,Testes, etc.)
Fetal Imaging& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other(Specify)
Peripheralvessel	Peripheral vessel	P	P	P		P	P	P5, P9
	Other(Specify)
	N=new system indication; P=previously cleared by FDA;
	1 Includes B-Mode and Harmonic (Contrast) imaging (HI)
	2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
	3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
	4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD)
5 Color M-Mode (CM)
	6 Abdominal includes renal, GYN/Pelvic
	7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) )
8 Freehand tissue elasticity
9 3D/4D
	10 CEUS (Contrast agent for LVO)
	11 CEUS (Contrast agent for Liver)
12 ARFI
System:	ZS3, z.one pro Ultrasound System
Transducer:	Phased (Sector) Array Transducer P4-1c
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	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal	P	P	P	P	P	P	p5
	Abdominal6	P	P	P	P	P	P	P5, N11
	Intra-operative (Specify)7
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	p5
	Small Organ (Thyroid, Breast,Testes, etc.)
	Neonatal Cephalic	P	P	P	P	P	P	p5
	Adult Cephalic/Transcranial	P	P	P	P	P	P	p5
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
Cardiac	Intravascular
	Cardiac Adult	P1	P	P	P	P	P	p5, p10
	Cardiac Pediatric	P	P	P	P	P	P	p5
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other(Specify)
Peripheralvessel	Peripheral vessel	P	P	P	P	P	P	p5
	Other (Specify)
	N=new system indication; P=previously cleared by FDA;
	1 Includes B-Mode and Harmonic (Contrast) imaging (HI)
	2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
	3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
	4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD)
5 Color M-Mode (CM)
	6 Abdominal includes renal, GYN/Pelvic
	7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) )
8 Freehand tissue elasticity
9 3D/4D
	10 CEUS (Contrast agent for LVO)
12 ARFI	11 CEUS (Contrast agent for Liver)



System:	ZS3, z.one pro Ultrasound System
Transducer:	Endo-Cavity Transducer E9-3
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	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	p5
	Abdominal®
	Intra-operative (Specify)'
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Thyroid, Breast,
Fetal Imaging	Testes, etc.)
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	p5
	Trans-vaginal	P	P	P		P	P	p5
	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
	Other(Specify)
Peripheral	Peripheral vessel
vessel	Other (Specify)
	N=new system indication; P=previously cleared by FDA;
	1 Includes B-Mode and Harmonic (Contrast) imaging (HI)
	2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
	3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
	4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD)
5 Color M-Mode (CM)
	6 Abdominal includes renal, GYN/Pelvic
	7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) )
8 Freehand tissue elasticity
9 3D/4D
	10 CEUS (Contrast agent for LVO)
	11 CEUS (Contrast agent for Liver)
12 ARFI



						Mode of Operation
System:	ZS3, z.one pro Ultrasound System
Transducer:	Endo-Cavity Transducer E9-4
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application
		B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
General(Track1 Only)	Specific(Track 1 & 3)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	p5
	Abdominal6
	Intra-operative (Specify)7
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Thyroid, Breast,Testes, etc.)
Fetal Imaging& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	p5
	Trans-vaginal	P	P	P		P	P	p5
	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
	Other(Specify)
Peripheralvessel	Peripheral vessel
	Other (Specify)
	N=new system indication; P=previously cleared by FDA;
	1 Includes B-Mode and Harmonic (Contrast) imaging (HI)
	2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
	3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
	4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, PD, PD, PD,
5 Color M-Mode (CM)
	6 Abdominal includes renal, GYN/Pelvic
	7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) )
8 Freehand tissue elasticity
9 3D/4D
	10 CEUS (Contrast agent for LVO)
	11 CEUS (Contrast agent for Liver)
12 ARFI

System:	ZS3, z.one pro Ultrasound System
Transducer:	Endo-Cavity Transducer E9-3 3D
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	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	ps, pº
	Abdominal6
	Intra-operative (Specify)'
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Thyroid, Breast,
Fetal Imaging	Testes, etc.)
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	ps, p9
	Trans-vaginal	P	P	P		P	P	ps, p9
	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
	Other(Specify)
Peripheral	Peripheral vessel
vessel	Other(Specify)
	N=new system indication; P=previously cleared by FDA;
	1 Includes B-Mode and Harmonic (Contrast) imaging (HI)
	2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
	3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
	4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD)
5 Color M-Mode (CM)
	6 Abdominal includes renal, GYN/Pelvic
	7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) )
8 Freehand tissue elasticity
9 3D/4D
	10 CEUS (Contrast agent for LVO)
	11 CEUS (Contrast agent for Liver)
12 ARFI




System:	ZS3, z.one pro Ultrasound System
Transducer:	Linear Transducer L10-5
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	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic	P		P		P	P
	Fetal	P	P	P		P	P	P5
	Abdominal6	P	P	P		P	P	P5, N11
	Intra-operative (Specify)7	P	P	P		P	P	P5
	Intra-operative (Neuro)	P		P		P	P	P5
	Laparoscopic
	Pediatric	P	P	P		P	P	P5
	Small Organ (Thyroid, Breast,Testes, etc.)	P	P	P		P	P	P5, P8
Fetal Imaging& Other	Neonatal Cephalic	P	P	P		P	P	P5
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P		P	P	P5, P8
	Musculo-skeletal (Superficial)	P	P	P		P	P	P5, P8
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other(Specify)
Peripheralvessel	Peripheral vessel	P	P	P		P	P	P5, P8
	Other(Specify)
	N=new system indication; P=previously cleared by FDA;
	1 Includes B-Mode and Harmonic (Contrast) imaging (HI)
	2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
	3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
	4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD)
5 Color M-Mode (CM)
	6 Abdominal includes renal, GYN/Pelvic
	7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) )
8 Freehand tissue elasticity
9 3D/4D
	10 CEUS (Contrast agent for LVO)11 CEUS (Contrast agent for Liver)
12 ARFI



System:	ZS3, z.one pro Ultrasound System
Transducer:	Linear Transducer L8-3
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	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P5
	Abdominal6	P	P	P		P	P	P5, N11
	Intra-operative (Specify)7	P	P	P		P	P	P5
	Intra-operative (Neuro)	P	P	P		P	P	P5
	Laparoscopic
	Pediatric	P	P	P		P	P	P5
Fetal Imaging& Other	Small Organ (Thyroid, Breast,Testes, etc.)	P	P	P		P	P	P5, P8
	Neonatal Cephalic	P	P	P		P	P	P5
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P		P	P	P5, P8
	Musculo-skeletal (Superficial)	P	P	P		P	P	P5, P8
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other(Specify)
Peripheralvessel	Peripheral vessel	P	P	P		P	P	P5, P8
	Other(Specify)
	N=new system indication; P=previously cleared by FDA;
	1 Includes B-Mode and Harmonic (Contrast) imaging (HI)
	2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
	3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
	4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD)
5 Color M-Mode (CM)
	6 Abdominal includes renal, GYN/Pelvic
	7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) )
8 Freehand tissue elasticity
9 3D/4D
	10 CEUS (Contrast agent for LVO)
12 ARFI	11 CEUS (Contrast agent for Liver)




System:	ZS3, z.one pro Ultrasound System
Transducer:	Linear Transducer L14-5sp
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	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic	P		P		P	P
	Fetal	P	P	P		P	P	p5
	Abdominal6	P	P	P		P	P	P5, N11
	Intra-operative (Specify)7	P	P	P		P	P	p5
	Intra-operative (Neuro)	P		P		P	P	p5
	Laparoscopic
	Pediatric	P	P	P		P	P	p5
	Small Organ (Thyroid, Breast,Testes, etc.)	P	P	P		P	P	p5, p8
Fetal Imaging& Other	Neonatal Cephalic	P	P	P		P	P	p5
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P		P	P	p5, p8
	Musculo-skeletal (Superficial)	P	P	P		P	P	p5, p8
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other(Specify)
Peripheralvessel	Peripheral vessel	P	P	P		P	P	p5, p8
	Other(Specify)
	N=new system indication; P=previously cleared by FDA;
	1 Includes B-Mode and Harmonic (Contrast) imaging (HI)
	2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
	3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
	4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD)
5 Color M-Mode (CM)
	6 Abdominal includes renal, GYN/Pelvic
	7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) )
8 Freehand tissue elasticity
9 3D/4D
	10 CEUS (Contrast agent for LVO)
	11 CEUS (Contrast agent for Liver)
12 ARFI



System:	ZS3, z.one pro Ultrasound System
Transducer:	Linear Transducer L14-5w
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	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic	P		P		P	P
	Fetal	P	P	P	CWD	P	P	p5
	Abdominal6	P	P	P		P	P	P5, N11
	Intra-operative (Specify)7	P	P	P		P	P	p5
	Intra-operative (Neuro)	P		P		P	P	p5
	Laparoscopic
	Pediatric	P	P	P		P	P	p5
	Small Organ (Thyroid, Breast,Testes, etc.)	P	P	P		P	P	p5, p8
Fetal Imaging& Other	Neonatal Cephalic	P	P	P		P	P	p5
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P		P	P	P5, P8
	Musculo-skeletal (Superficial)	P	P	P		P	P	p5, p8
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other(Specify)
Peripheralvessel	Peripheral vessel	P	P	P		P	P	p5, p8
	Other(Specify)
	N=new system indication; P=previously cleared by FDA;
	1 Includes B-Mode and Harmonic (Contrast) imaging (HI)
	2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
	3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
	4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD)
5 Color M-Mode (CM)
	6 Abdominal includes renal, GYN/Pelvic
	7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) )
8 Freehand tissue elasticity
9 3D/4D
	10 CEUS (Contrast agent for LVO)
	11 CEUS (Contrast agent for Liver)
12 ARFI



System:	ZS3, z.one pro Ultrasound System
Transducer:	Linear Transducer L20-5
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	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic	P		P		P	P
	Fetal	P	P	P		P	P	p5
	Abdominal6	P	P	P		P	P	P5, N11
	Intra-operative (Specify)7	P	P	P		P	P	p5
	Intra-operative (Neuro)	P		P		P	P	p5
	Laparoscopic
	Pediatric	P	P	P		P	P	p5
	Small Organ (Thyroid, Breast,Testes, etc.)	P	P	P		P	P	p5, p8
Fetal Imaging& Other	Neonatal Cephalic	P	P	P		P	P	p5
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P		P	P	p5, p8
	Musculo-skeletal (Superficial)	P	P	P		P	P	p5, p8
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other(Specify)
Peripheralvessel	Peripheral vessel	P	P	P		P	P	p5, p8
	Other(Specify)
	N=new system indication; P=previously cleared by FDA;
	1 Includes B-Mode and Harmonic (Contrast) imaging (HI)
	2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
	3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
	4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD)
5 Color M-Mode (CM)
	6 Abdominal includes renal, GYN/Pelvic
	7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) )
8 Freehand tissue elasticity
9 3D/4D
	10 CEUS (Contrast agent for LVO)
	11 CEUS (Contrast agent for Liver)
12 ARFI


System:	ZS3, z.one pro Ultrasound System
Transducer:	Tran-Esophageal Transducer P8-3TEE
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	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal6
	Intra-operative (Specify)7
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Thyroid, Breast,Testes, etc.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)	P	P	P	P	P	P	P5
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)	P	P	P	P	P	P	P5, N10
	Intra-cardiac
	Other(Specify)
Peripheralvessel	Peripheral vessel
	Other(Specify)
	N=new system indication; P=previously cleared by FDA;
	1 Includes B-Mode and Harmonic (Contrast) imaging (HI)
	2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
	3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
	4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD)
5 Color M-Mode (CM)
	6 Abdominal includes renal, GYN/Pelvic
	7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) )
8 Freehand tissue elasticity
9 3D/4D
	10 CEUS (Contrast agent for LVO)
	11 CEUS (Contrast agent for Liver)
12 ARFI

System:	ZS3, z.one pro Ultrasound System
Transducer:	Phased (Sector) Array Transducer P9-3ic ( St.Jude EP ViewFlex PLUS ICE Catheter model # VF-
	PM Part #09-2005 (off the shelf)
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	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal6
	Intra-operative (Specify)7
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Thyroid, Breast,Testes, etc.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac	P	P	P	P	P	P	N10
	Other (Specify)

Peripheralvessel	Peripheral vessel
	Other (Specify)
	N=new system indication; P=previously cleared by FDA;
	1 Includes B-Mode and Harmonic (Contrast) imaging (HI)
	2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
	3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
	4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD)
5 Color M-Mode (CM)
	6 Abdominal includes renal, GYN/Pelvic
	7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) )
8 Freehand tissue elasticity
9 3D/4D
	10 CEUS (Contrast agent for LVO)
	11 CEUS (Contrast agent for Liver)
12 ARFI
						Mode of Operation
System:	ZS3, z.one pro Ultrasound System
Transducer:	A2CW (Common name Pencil Probe)
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application
General(Track1 Only)	Specific(Track 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal6
	Intra-operative (Specify)7
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric				P
	Small Organ (Thyroid, Breast,Testes, etc.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult				P
	Cardiac Pediatric				P
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other(Specify)
	Peripheralvessel	Peripheral vessel
		Other (Specify)
		N=new system indication; P=previously cleared by FDA;
	1 Includes B-Mode and Harmonic (Contrast) imaging (HI)
	2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
	3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
	4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD)
5 Color M-Mode (CM)
	6 Abdominal includes renal, GYN/Pelvic
	7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) )
8 Freehand tissue elasticity
9 3D/4D
	10 CEUS (Contrast agent for LVO)
	11 CEUS (Contrast agent for Liver)
12 ARFI

System:	ZS3, z.one pro Ultrasound System
Transducer:	A5CW (Common name Pencil Probe)
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
General(Track				PWD		Color	Combined
1 Only)	Specific(Track 1 & 3)	B	M	2	CWD	Doppler3	Modes4	Other
Ophthalmic	Ophthalmic
	Fetal
	Abdominal®
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric				P
	Small Organ (Thyroid, Breast,
Fetal Imaging	Testes, etc.)
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other(Specify)
Peripheral	Peripheral vessel				P
vessel	Other(Specify)
	N=new system indication; P=previously cleared by FDA;
	1 Includes B-Mode and Harmonic (Contrast) imaging (HI)
	2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
	3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
	4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD)
5 Color M-Mode (CM)
	6 Abdominal includes renal, GYN/Pelvic
	7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) )
8 Freehand tissue elasticity
9 3D/4D
	10 CEUS (Contrast agent for LVO)
	11 CEUS (Contrast agent for Liver)
12 ARFI

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mind 同篇

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mind

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System:	ZS3, z.one pro Ultrasound System
Transducer:	Curvilinear Transducer C9-3sp
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	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	p5
	Abdominal6	P	P	P		P	P	PS, N11
	Intra-operative (Specify)7.1、7.3	P	P	P		P	P	p5
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	p5
	Small Organ (Thyroid, Breast,
Fetal Imaging	Testes, etc.)
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P		P	P	p5
	Musculo-skeletal (Superficial)	P	P	P		P	P	p5
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other(Specify)
Peripheral	Peripheral vessel	P	P	P		P	P	p5
vessel	Other (Specify)
	N=new system indication: P=previously cleared by FDA;
	1 Includes B-Mode and Harmonic (Contrast) imaging (HI)
	2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
	3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
	4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD)
5 Color M-Mode (CM)
	6 Abdominal includes renal, GYN/Pelvic
	7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) )
8 Freehand tissue elasticity
9 3D/4D
	10 CEUS (Contrast agent for LVO)
	11 CEUS (Contrast agent for Liver)
12 ARFI

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System:	ZS3, z.one pro Ultrasound System
Transducer:	Curvillinear Transducer C6-1
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	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	N³
	Abdominal®	N	N	N		N	N	N³, Nº1
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N-
	Small Organ (Thyroid, Breast,
Fetal Imaging	Testes, etc.)
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other(Specify)
Peripheral	Peripheral vessel	N	N	N		N	N	N-
vessel	Other (Specify)
	N=new system indication; P=previously cleared by FDA;
	1 Includes B-Mode and Harmonic (Contrast) imaging (HI)
	2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
	3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
	4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, PD, PD, PD,
5 Color M-Mode (CM)
	6 Abdominal includes renal, GYN/Pelvic
	7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) )
8 Freehand tissue elasticity
9 3D/4D
	10 CEUS (Contrast agent for LVO)
	11 CEUS (Contrast agent for Liver)
12 ARFI

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						Mode of Operation
Clinical Application	General(Track1 Only)	Specific(Track 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
	Ophthalmic	Ophthalmic	N		N		N	N	N5
		Fetal	N	N	N		N	N	N5
		Abdominal6	N	N	N		N	N	N5, N11
		Intra-operative (Specify)7.1, 7.3
		Intra-operative (Neuro)
		Laparoscopic
		Pediatric
		Small Organ (Thyroid, Breast,Testes, etc.)	N	N	N		N	N	N5
Fetal Imaging& Other		Neonatal Cephalic
		Adult Cephalic
		Trans-rectal
		Trans-vaginal
		Trans-urethral
		Trans-esoph. (non-Card.)
		Musculo-skeletal (Conventional)	N	N	N		N	N	N5
		Musculo-skeletal (Superficial)	N	N	N		N	N	N5
		Intravascular
		Cardiac Adult
		Cardiac Pediatric
		Intravascular (Cardiac)
Cardiac		Trans-esoph. (Cardiac)
		Intra-cardiac
		Other (Specify)
Peripheralvessel		Peripheral vessel	N	N	N		N	N	N5
		Other (Specify)
N=new system indication; P=previously cleared by FDA;
1 Includes B-Mode and Harmonic (Contrast) imaging (HI)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD)
5 Color M-Mode (CM)
6 Abdominal includes renal, GYN/Pelvic
7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) )
8 Freehand tissue elasticity
9 3D/4D
10 CEUS (Contrast agent for LVO)
11 CEUS (Contrast agent for Liver)
12 ARFI

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mind/ 道瑞

System:	ZS3, z.one pro Ultrasound System
Transducer:	Tran-Esophageal Transducer P8-3mTEE
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	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic
	Fetal
	Abdominal6
	Intra-operative (Specify)7
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Thyroid, Breast,Testes, etc.)
Fetal Imaging& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)	N	N	N	N	N	N	N5
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)	N	N	N	N	N	N	N5, N10
	Intra-cardiac
	Other (Specify)
Peripheralvessel	Peripheral vessel
	Other (Specify)
	N=new system indication; P=previously cleared by FDA;
	1 Includes B-Mode and Harmonic (Contrast) imaging (HI)
	2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
	3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
	4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD)
5 Color M-Mode (CM)
	6 Abdominal includes renal, GYN/Pelvic
	7 Intra operative include ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) )
8 Freehand tissue elasticity
9 3D/4D
	10 CEUS (Contrast agent for LVO)
	11 CEUS (Contrast agent for Liver)
12 ARFI

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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.

1. Submitter:

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

Tel: +86 755 8188 5604 Fax: +86 755 2658 2680

Contact Person:

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

Date Prepared: June 12, 2017

2. Device Name: ZS3 and z.one pro Ultrasound Systems

Classification

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

3. Device Description:

The exam dependent default settings for the ZS3 and z.one pro allow the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control

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enables the advanced user to set the system based on image appearance preference. The architecture of the ZS3 and z.one pro Ultrasound Systems support system integration to a variety of upgradable options and features. Up to three transducers can be connected to the multi-transducer port permitting easy transducer transition. The system can be operated on either battery or AC power.

4. Intended Use:

The ZS3 and z.one pro Ultrasound Systems are intended for use by a qualified physician for ultrasound evaluation of Opthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic(cardiac), and vascular); Intraoperative(Neuro); Pediatric; Small organ (thyroid, breast, testes, etc); Neonatal cephalic; Adult Cephalic/Transcranial; Trans-rectal; Trans-vaginal; Trans-esoph.(non-Card); Musculoskeletal(Conventional); Musculoskeletal(Superficial); Cardiac Adult; Cardiac Pediatric; Trans-esoph. (Cardiac); Intra-cardiac; Peripheral vessel.

5. Summary of Modifications and New Added Features

This submission is modification to ZS3 and z.one pro Ultrasound Systems previously cleared in K151175.

The following is a brief overview of the modifications and new added features.

Newly added transducers C6-1, C18-5, P8-3mTEE
■ Newly added features ARFI CEUS (Contrast agent for Liver) Add CEUS (Contrast agent for LVO) function to transducers C10-3, P8-3TEE, P9-3ic and P8-3mTEE Smart OB Smart NT Auto EF Auto IMT Stress Echo Anatomical M Needle-Guided bracket NGB-022(cleared in K141010)

6. Comparison to Predicate Devices:

The modified ZS3 and z.one pro Ultrasound Systems are comparable with and substantially equivalent to these predicate devices:

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PredicateDevice	Manufacturer	Model	510(k)Number
1	Zonare	ZS3, z.one pro	K151175
2	Mindray	DC-8	K170277
3	GE Healthcare	Voluson S8	K160184
4	GE Healthcare	Logiq E9	K163077
5	Mindray	M9	K152543

The modified ZS3 and z.one pro Ultrasound Systems employ 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 has the same intended use as the predicated device ZS3/z.one ■ pro(K151175)

Items	Subject DeviceZS3/z.one pro	Predicate deviceZS3/z.one pro(K151175)
Intended Use	The ZS3 and z.one pro UltrasoundSystems are intended for use by aqualified physician for ultrasoundevaluation ofOpthalmic;Fetal;Abdominal (renal, GYN/Pelvic);Intra-operative (abdominal,thoracic(cardiac), and vascular);Intra-operative (Neuro);Pediatric;Small organ (thyroid, breast,testes, etc); Neonatal cephalic;Adult Cephalic/Transcranial;Trans-rectal;Trans-vaginal;Trans-esoph.(non-Card);Musculoskeletal(Conventional);Musculoskeletal(Superficial);	The ZS3 and z.one proUltrasound Systems areintended for use by aqualified physician forultrasoundevaluation ofOphthalmic;Fetal/obstetric,gynecological;Abdominal(renal,GYN/Pelvic);Intra-operative (abdominal,thoracic, and vascular),Intra-operativeneurological;Pediatric: small organ(thyroid, breast,testes, etc),Adult & Neonatal Cephalic;Trans-rectal

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Cardiac Adult;Cardiac Pediatric;Trans-esoph. (Cardiac);Intra-cardiac;Peripheral vessel.	Trans-vaginal,Trans-cranial,Trans-esophageal(non-cardiac and cardiac);Musculosketal(conventional &superficial);3D/4D;Cardiac - Adult/ Pediatric/Fetal;Echo, Intra-Cardiac;Pelvic;Peripheral vascular;harmonic tissue andcontrast imaging andTissue elasticity
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. The patient contact materials of the new added transducers and needle-guided bracket are tested under ISO 10993-1.
The acoustic power levels of modified ZS3 and z.one pro are below the limits of FDA, . which are the same as the predicated device ZS3 and z.one pro (K151175).
The modified ZS3 and z.one pro are designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device ZS3 and z.one pro (K151175).
The modified ZS3 and z.one pro have the same imaging modes as the predicated devices.
The new added features of modified ZS3 and z.one pro are the same as the predicated devices.
. The modified ZS3 and z.one pro have similar transducers with the predicated devices.

7. Non-clinical Tests:

ZS3 and z.one pro Ultrasound Systems have 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: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

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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
. ISO14971: Medical devices - Application of risk management to medical devices
. UD 2: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
. UD 3: Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
ISO 10993-1: Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

8. Clinical Tests:

Not Applicable.

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 ZS3 and z.one pro Ultrasound Systems are substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.