The ZS3 and z.one pro Ultrasound Systems are intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic(cardiac); Intraoperative (Neuro); Laparoscopic; Pediatic; Small organ (thyroid, breast, testes, etc); Neonatal 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.

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

This document describes the 510(k) premarket notification for the ZS3 and z.one pro Ultrasound Systems. This is a notification of intent to market a medical device, asserting its substantial equivalence to previously cleared devices. Therefore, the information provided focuses on demonstrating this equivalence through non-clinical testing and comparison to predicates, rather than extensive clinical studies or formal acceptance criteria for an AI/CADe device.

Based on the provided information, the device is an ultrasound system and not an AI/CADe device. As such, the typical acceptance criteria and study design for AI/CADe devices (multireader multi-case studies, ground truth establishment by multiple experts, defined performance metrics like sensitivity/specificity, etc.) are not applicable to this submission.

The acceptance criteria here pertain to the ultrasound system's performance and safety standards, and the "study" proving acceptance is a series of non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is an ultrasound system and not an AI/CADe device, the acceptance criteria are based on compliance with recognized safety and performance standards for ultrasound equipment. The "reported device performance" is implicitly that the device conforms to these standards.

Acceptance Criteria Category	Specific Standard/Requirement	Reported Device Performance (Implicit)
Electrical Safety	AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod).	Conforms with all applicable parts.
Electromagnetic Compatibility (EMC)	IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests	Conforms with all applicable parts.
Safety for Ultrasonic Devices	IEC 60601-2-37 Edition 2.1 2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment	Conforms with all applicable parts.
Software Life Cycle Processes	IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes	Conforms with all applicable parts.
Risk Management	ISO 14971 Second edition 2007-03-01 Medical devices - Application of risk management to medical devices	Conforms with all applicable parts.
Acoustic Output	NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic ultrasound equipment revision 3.	Acoustic power levels are below FDA limits.
Biocompatibility	AAMI / ANSI / ISO 10993-1:2009/(R)2013, biological evaluation of medical devices - part 1: evaluation and testing within a risk management process.	Conforms with all applicable parts.
Cleaning and Disinfection	(Implicitly tested and found conforming)	Effectiveness evaluated and conforms.
Thermal & Mechanical Safety	(Implicitly tested and found conforming)	Safety evaluated and conforms.

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

This document describes a 510(k) submission for an ultrasound imaging system. As such, it does not involve a "test set" or "data provenance" in the sense of a machine learning model's evaluation data. Instead, validation is based on non-clinical tests (electrical safety, acoustic output, biocompatibility, etc.) performed on the physical device and its components, in accordance with recognized industry standards. The data provenance would be the results from these engineering and biological safety tests. The specific "sample size" of devices or components tested is not detailed in this summary but is generally part of standard engineering verification and validation.

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

Not applicable. This is not an AI/CADe device, and therefore, an expert-established "ground truth" for a diagnostic test set is not relevant to its 510(k) submission. The "ground truth" for a device like this is its adherence to safety and performance standards.

4. Adjudication Method for the Test Set:

Not applicable, as there is no "test set" in the context of diagnostic interpretation that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This is an ultrasound imaging system, not an AI/CADe device designed to assist human readers, so such a study is not relevant.

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

Not applicable. This is not an AI/CADe device.

7. The Type of Ground Truth Used:

The "ground truth" for this device's acceptance is its compliance with established safety and performance standards for diagnostic ultrasound equipment, as detailed in section 7 ("Non-clinical Tests") of the 510(k) summary. This includes standards for electrical safety, acoustic output, biocompatibility, and software development, rather than clinical outcomes or expert consensus on image interpretation.

8. The Sample Size for the Training Set:

Not applicable. This is a hardware/software medical device (ultrasound system), not an AI/CADe system that undergoes machine learning training with a specific "training set."

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

Not applicable, as there is no "training set" for this type of device. The specifications and performance are established through engineering design, quality control, and adherence to regulatory standards.

Summary

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

December 19, 2019

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

Re: K192410

Trade/Device Name: ZS3 and z.one pro Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: November 15, 2019 Received: November 18, 2019

Dear Jiang Haosen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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 medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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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Indications for Use

510(k) Number (if known) K192410

Device Name

ZS3 and z.one pro Ultrasound Systems

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
✔ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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(Track 1Only)	Specific(Track 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic	P		P		P	P
	Fetal	P	P	P	P	P	P	P5, P9
	Abdominal6	P	P	P	P	P	P	P5, P9, P11, P12, N13
	Intra-operative (Specify)7	P	P	P		P	P	P5
	Intra-operative (Neuro)	P	P	P		P	P	P5
	Laparoscopic	N	N	N		N	N	N5, N11
	Pediatric	P	P	P	P	P	P	P5, P9
	Small Organ (Thyroid,Breast, Testes, etc.)	P	P	P		P	P	P5, p8
Fetal Imaging &Other	Neonatal Cephalic	P	P	P	P	P	P	P5
	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	P	P5, p8
	Intravascular
	Cardiac Adult	P1	P	P	P	P	P	P5, P10
	Cardiac Pediatric	P	P	P	P	P	P	p5 p10

Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)	P	P	P	P	P	P	P5, p10
	Intra-cardiac	P	P	P	P	P	P	P10, N5
	Other(Specify)
	Peripheral vessel	P	P	P	P	P	P	P5, P8, P9
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
13 2D SWI
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	Mode of Operation
General(Track 1Only)	Specific(Track 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	N5
	Abdominal6	P	P	P	P	P	P	P11, P12, N5,N13
	Intra-operative (Specify)7
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	N5
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic/Transcranial
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P	P	P		P		N5
	Musculo-skeletal(Superficial)
	Intravascular
	Cardiac Adult	P1	P	P	P	P	P	P10, N5
Cardiac	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other(Specify)
Peripheral vessel	Peripheral vessel	N	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
13 2D SWI

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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	Mode of Operation
General(Track 1Only)	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, p11
	Intra-operative (Specify)7
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	p5
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic/Transcranial
	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 vessel	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
13 2D SWI

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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 (Track 1Only)	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, p11
	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.)	N	N	N		N	N	N5
Fetal Imaging &Other	Neonatal Cephalic
	Adult Cephalic/Transcranial
	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
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other(Specify)
	Peripheral vessel	P	P	P		P	P	p5
	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:	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(Track 1Only)	Specific(Track 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic	P		P		P	P
	Fetal	P	P	P	P	P	P	p5
	Abdominal6	P	P	P	P	P	P	p5, p11
	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
	Small Organ (Thyroid,Breast, Testes, etc.)
Fetal Imaging &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, p10
	Cardiac Pediatric	P	P	P	P	P	P	p5, p10
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other(Specify)
Peripheral vessel	Peripheral vessel	P	P	P	P	P	P	p5
	Other(Specify)
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						Mode of Operation
General(Track 1						Color	Combined
Only)	Specific(Track 1 & 3)	B	M	PWD2	CWD	Doppler3	Modes4	Other
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P5, P9
	Abdominal6	P	P	P		P	P	P5, P9, P11
	Intra-operative (Specify)7
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P5, P9
	Small Organ (Thyroid,
	Breast, Testes, etc.)
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic/
Other	Transcranial
	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 vessel	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, 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
13 2D SWI
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(Track 1	Specific(Track 1 & 3)	B	M	PWD2	CWD	Color	Combined	Other
Only)						Doppler3	Modes4
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	p5
	Abdominal6	P	P	P	P	P	P	p5, p11
	Intra-operative (Specify)7
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	p5
	Small Organ (Thyroid,
	Breast, Testes, etc.)
Fetal Imaging &	Neonatal Cephalic	P	P	P	P	P	P	p5
Other	Adult	P	P	P	P	P	P	p5
	Cephalic/TranscranialTrans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
	(Conventional)
	Musculo-skeletal
	(Superficial)
	Intravascular
	Cardiac Adult	P1	P	P	P	P	P	p5, p10
	Cardiac Pediatric	P	P	P	P	P	P	p5
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other(Specify)
Peripheral vessel	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, 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
13 2D SWI
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(Track 1
Only)	Specific(Track 1 & 3)	B	M	PWD2	CWD	ColorDoppler³	CombinedModes⁴	Other
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	p⁵
	Abdominal⁶	N	N	N		N	N	N⁵
	Intra-operative (Specify)⁷
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic/Transcranial
	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 vessel	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:	Endo-Cavity Transducer E9-4
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application						Mode of Operation
General(Track 1Only)	Specific(Track 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	p5
	Abdominal6	N	N	N		N	N	N5
	Intra-operative (Specify)7
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic/Transcranial
	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
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other(Specify)
	Peripheral vessel
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
13 2D SWI
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(Track 1Only)	Specific(Track 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P5, P9
	Abdominal6	N	N	N		N	N	N5, N9
	Intra-operative (Specify)7
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic/Transcranial
	Trans-rectal	P	P	P		P	P	P5, P9
	Trans-vaginal	P	P	P		P	P	P5, P9
	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
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:	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(Track 1Only)	Specific(Track 1 & 3)	B	M	PWD2	CWD	ColorDoppler³	CombinedModes4	Other
Ophthalmic	Ophthalmic	P	P	P		P	P
	Fetal	P	P	P		P	P	p5
	Abdominal6	P	P	P		P	P	p5, p11
	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
	Neonatal Cephalic	P	P	P		P	P	p5
Fetal Imaging &Other	Adult Cephalic/Transcranial
	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)
Peripheral vessel	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
13 2D SWI
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(Track 1Only)	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, p11
	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
	Small Organ (Thyroid,Breast, Testes, etc.)	P	P	P		P	P	p5, p8
	Neonatal Cephalic	P	P	P		P	P	p5
Fetal Imaging &Other	Adult Cephalic/Transcranial
	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)
Peripheral vessel	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
13 2D SWI
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(Track 1Only)	Specific(Track 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
	Ophthalmic	P		P		P	P	p5
	Fetal	P	P	P		P	P	p5
	Abdominal6	P	P	P		P	P	p5, p11
	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
	Small Organ (Thyroid,Breast, Testes, etc.)	P	P	P		P	P	p5, p8
	Neonatal Cephalic	P	P	P		P	P	p5
Fetal Imaging &Other	Adult Cephalic/Transcranial
	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)
Peripheral vessel	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
13 2D SWI
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	Specific(Track 1 & 3)	B	M	PWD2	CWD	Color Doppler3	Combined Modes4	Other
General(Track 1 Only)	Ophthalmic	P		P		P	P
Fetal Imaging & Other	Fetal	P	P	P		P	P	p5
	Abdominal6	P	P	P		P	P	p5, p11
	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
	Neonatal Cephalic	P	P	P		P	P	p5
	Adult Cephalic/Transcranial
	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
Cardiac	Intravascular
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other(Specify)
	Peripheral vessel	P	P	P		P	P	p5, p8
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
13 2D SWI
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
	Specific(Track 1 & 3)	B	M	PWD2	CWD	Color Doppler3	Combined Modes4	Other
General(Track 1Only)	Ophthalmic	P		P		P	P
Fetal Imaging &Other	Fetal	P	P	P		P	P	p5
	Abdominal6	P	P	P		P	P	p5, p11
	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
	Neonatal Cephalic	P	P	P		P	P	p5
	Adult Cephalic/Transcranial
	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	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other(Specify)
	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
13 2D SWI
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(Track 1Only)	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.)
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic/Transcranial
	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
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)	P	P	P	P	P	P	P5, P10
	Intra-cardiac
	Other(Specify)
	Peripheral vessel
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
General(Track 1Only)	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/Transcranial
	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	P	P	P	P	P	P	P10, N5
	Other (Specify)
	Peripheral vessel
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
13 2D SWI

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						Mode of Operation
General(Track 1Only)	Specific(Track 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic
	Fetal
	Abdominal6
	Intra-operative (Specify)7
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric				P
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic/Transcranial
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Cardiac Adult				P
	Cardiac Pediatric				P
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other(Specify)
Peripheral vessel	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
13 2D SWI
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 1Only)	Specific(Track 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic
	Fetal
	Abdominal6
	Intra-operative (Specify)7
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric				P
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic/
	Transcranial
	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
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
13 2D SWI
System:	ZS3, z.one pro Ultrasound System
Transducer:	Curvilinear Transducer C9-3sp
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:Intended Use:
Clinical Application						Mode of Operation
General(Track 1Only)	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, p11
	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.)
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic/Transcranial
	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
	IntravascularCardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other(Specify)
	Peripheral vessel	P	P	P		P	P	p5
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 elasticity9 3D/4D
10 CEUS (Contrast agent for LVO)
11 CEUS (Contrast agent for Liver)
12 ARFI
13 2D SWI
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(Track 1Only)	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, p11
	Intra-operative (Specify)7
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric		P	P	P		P	P	p5
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic/Transcranial
	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 vessel		P	P	P		P	P	p5
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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System:	ZS3, z.one pro Ultrasound System
Transducer:	Curvillinear Transducer C18-5
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
General(Track 1Only)	Specific(Track 1 & 3)	B	M	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, p11
	Intra-operative (Specify)7	N	N	N		N	N	N5
	Intra-operative (Neuro)	N	N	N		N	N	N5
	Laparoscopic
	Pediatric	N	N	N		N	N	N5
	Small Organ (Thyroid,Breast, Testes, etc.)	P	P	P		P	P	p5
	Neonatal Cephalic	N	N	N		N	N	N5
Fetal Imaging &Other	Adult Cephalic/Transcranial
	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 vessel	P	P	P		P	P	p5
	Other (Specify)
Peripheral vessel	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
13 2D SWI

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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(Track 1Only)	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.)
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic/Transcranial
	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
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)	P	P	P	P	P	P	p5, p10
	Intra-cardiac
	Other (Specify)
	Peripheral vessel
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
13 2D SWI
System:	ZS3, z.one pro Ultrasound System
Transducer:	L30-8
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application								Mode of Operation
General(Track 1Only)	Specific(Track 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic	N		N		N	N
	Fetal
	Abdominal6
	Intra-operative (Specify)7
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Thyroid,Breast, Testes, etc.)	N	N	N		N	N	N5
	Neonatal Cephalic	N	N	N		N	N	N5
Fetal Imaging &Other	Adult Cephalic/Transcranial
	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)
Peripheral vessel		Peripheral vessel	N	N	N		N	N
	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
13 2D SWI
System:	ZS3, z.one pro Ultrasound System
Transducer:	P7-3c
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:Intended Use:
Clinical Application
General(Track 1Only)	Specific(Track 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	N	N5
	Abdominal6	N	N	N	N	N	N	N5, N11
	Intra-operative (Specify)7
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N5
	Small Organ (Thyroid,Breast, Testes, etc.)
Fetal Imaging &Other	Neonatal Cephalic	N	N	N	N	N	N	N5
	Adult Cephalic/Transcranial	N	N	N	N	N	N	N5
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Cardiac Adult	N	N	N	N	N	N	N5, N10
	Cardiac Pediatric	N	N	N	N	N	N	N5
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral vessel	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
13 2D SWI
System:	ZS3, z.one pro Ultrasound System
Transducer:	C12-4lp
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
	General(Track 1Only)	Specific(Track 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other
Ophthalmic	Ophthalmic
	Fetal
	Abdominal6
	Intra-operative (Specify)7
	Intra-operative (Neuro)
	Laparoscopic	N	N	N		N	N	N5, N11
	Pediatric
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic/Transcranial
	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 vessel	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
13 2D SWI

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K192410

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 8807.92(c).

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 6183 Fax: +86 755 2658 2680

Contact Person:

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

Date Prepared: August 30, 2019

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. Indications for Use:

The ZS3 and z.one pro Ultrasound Systems are intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic (cardiac), and vascular); Intraoperative (Neuro); Laparoscopic; 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 K171891.

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

Newly added transducers ■ L30-8, P7-3c, C12-4lp
. Newly added features 2D SWI CEUS QI Needle OPT TTOA HD Scope Add CM (Color M-Mode) function to transducers C4-1, P9-3ic Protocol MV slope measurement

Newly added Exam Mode . Vascular for C4-1; Small Parts for C9-3; Abdominal for E9-3, E9-4 and E9-3 3D; Intra-operative, Pediatric and NeoHead for C18-5 . Material changed for some previous licensed transducers Mucilage glue is changed from RTV 167 to RTV 162 for transducer C4-1, C6-2, P4-1c, C9-3, C10-3, L8-3, L14-5w, L10-5, L14-5sp.

. Newly added accessories Gel Warmer; wireless Ethernet Routers and Bridges

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6. Comparison to Predicate Devices:

Predicate Device	Manufacturer	Model	510(k)Number
1. Primarypredicate device	Mindray	ZS3, z.one pro	K171891
2. Referencedevice	Hitachi	NoblusTM	K160559
3. Referencedevice	Mindray	Resona 7	K171233
4. Referencedevice	GE Healthcare	Logiq P9	K181783

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

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 indications for use and basic operating modes as the predicate devices.

. Subject device has the same indications for use as the predicated device ZS3/z.one pro(K171891); laparoscopic as the predicated device NOBLUS™ (K160559)
The patient contact materials of the new added transducers, material changed transducers and newly added intra-operative application for previous licensed transducers 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 (K171891).
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 (K171891).
. 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.
1 The modified ZS3 and z.one pro have similar transducers with the predicated devices.

7. Non-clinical Tests:

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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 ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod).
. IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
. IEC 60601-2-37 Edition 2.1 2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
. IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes
. ISO 14971 Second edition 2007-03-01 Medical devices - Application of risk management to medical devices
. NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic ultrasound equipment revision 3.
AAMI / ANSI / ISO 10993-1:2009/(R)2013, biological evaluation of medical devices - part 1: evaluation and testing within a risk management process.

8. Clinical Tests:

Not Applicable. The subject of this submission. ZS3 and z.one pro Ultrasound Systems. do not require clinical studies to support substantial equivalence.

Conclusion:

Indications for Use 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.

Image /page/32/Picture/12 description: The image shows the text "Page 4 of 4" at the top, indicating it is the last page of a document. Below that, the number "007-004" is displayed in a large, bold font. This number likely serves as a document or page identifier. The overall layout is simple and focuses on clearly presenting the page number and document ID.

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.