ZONARE ZS3 Diagnostic Ultrasound System by ZONARE MEDICAL SYSTEMS, INC.

The ZS3 and z.one PRO Ultrasound Systems are intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal/obstetric, gynecological; Abdominal (renal, GYN/Pelvic; Intra-operative (abdominal, thoracic, and vascular), Intra-operative neurological; Pediatric: small organ (thyroid, breast, testes, etc), Adult & Neonatal Cephalic; Trans-recinal, Trans-cranial, Trans-sophageal (non-cardiac and cardiac); Musculosketal (conventional & superficial); 3D/4D; Cardiac - Adultí Pediativ Fetal; Echo, Intra-Cardiac; Peripheral vascular; harmonic tissue and contrast imaging and Tissue elasticity.

Device Description

The ZS3 and z.onewo Ultrasound Systems (hereafter referred to as "ZS3 Ultrasound Platform" or "ZS3" for simplicity) 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 platform utilizes ZONARE's patented zone technology which allows the system to collect more data at one time, thereby optimizing image quality.

AI/ML Overview

This document describes the ZONARE Medical Systems, Inc. ZS3 and z.onepro Ultrasound Systems, which were submitted for 510(k) premarket notification (K151175). The submission primarily concerns adding new patient contacting materials to the E9-4 transducer and expanding the indications for use for one transducer (C9-3sp), stating that the core system and other transducers remain unchanged from a previous clearance (K150249).

Here's an analysis of the provided information concerning acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

For this submission, the acceptance criteria are based on compliance with various safety and performance standards for ultrasound systems and the equivalence to a previously cleared predicate device. The reported device performance is presented as "PASS" for all tested categories.

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Mechanical Verification	In accordance with device performance specifications (details not provided)	PASS
Electrical Safety	In accordance with IEC 60601-1	PASS
EMC Testing	In accordance with IEC 60601-1-2	PASS
Thermal & Acoustic Output	In accordance with IEC 60601-2-37, and specific limits for Derated IspTA (720mW/cm² max), Mechanical Index (≤ 1.9 max or Derated IsPPA ≤ 190 W/cm² max), and Ophthalmic use (TI ≤ 1, ISPTA.3 < 50mW/cm², MI < 0.23)	PASS
Biocompatibility	In accordance with ISO 10993 (for patient contacting materials, specifically Momentive RTV162 silicones and Loctite K64481 = Hysol M21-HP added to E9-4 transducer)	PASS
Cleaning & Disinfection	In accordance with FDA Guidance Document (details not provided)	PASS
Software Validation & Verification	In accordance with IEC 62304 and FDA Guidance Document Principles of Software Validation	PASS

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

The document does not explicitly mention a "test set" in the context of a clinical study with a specific sample size. The testing performed is described as "Non-Clinical Testing" and focuses on engineering and regulatory compliance rather than clinical performance evaluation on a patient population.

The data provenance is from non-clinical testing performed by ZONARE Medical Systems, Inc. It is not clinical data and therefore not categorized as retrospective or prospective in the traditional sense of patient studies.

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

This information is not applicable to the provided document. The submission concerns technical and safety compliance of an ultrasound system, not the performance of an algorithm that relies on expert interpretation to establish a ground truth for a test set. There were no "experts" establishing ground truth in the context of clinical device performance for this specific submission as no clinical studies were deemed necessary.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical test set requiring adjudication by experts is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The device is an ultrasound system, not an AI-assisted diagnostic tool described in the typical sense of MRMC studies. The document does not mention any AI components or comparative effectiveness studies of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is an ultrasound system, not an algorithm, and no standalone algorithm performance is discussed.

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

The concept of "ground truth" as typically used in AI/CAD performance evaluations is not directly applicable here. The "truth" for the non-clinical tests is established by adherence to recognized electrical, mechanical, thermal, acoustic, biocompatibility, and software standards, as well as the stated device performance specifications.

8. The Sample Size for the Training Set

This information is not applicable as this is not an AI/ML device that requires a training set.

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

This information is not applicable as this is not an AI/ML device and therefore no training set was used.

In summary, this document is a 510(k) premarket notification for an ultrasound system, primarily focusing on modifications that maintain substantial equivalence to an already cleared device. The "studies" are non-clinical engineering and regulatory compliance tests, not clinical performance studies involving patient data or AI algorithms.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is enclosed within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

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

May 15, 2015

ZONARE Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K151175

Trade/Device Name: ZS3 and z.onepro Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: April 30, 2015 Received: May 1, 2015

Dear Mr. Job:

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,

Robert A Ochs

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

Enclosure

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

(k) Number (if known)

K151175 Device Name

ZS3and z.oneproUltrasound 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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10(k) Number (if known)

Device Name

System: ZS3and z.onepro Ultrasound Systems Transducer: System union of all transducer types

Indications for Use (Describe)

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

Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other5, 8
Ophthalmic	Ophthalmic	P		P		P	P
	Fetal	P	P	P	P	P	P	P5
	Abdominal	P	P	P	P	P	P	P5
	Intra-operative(Specify)6	P	P	P		P	P	P5
	Intra-operative (Neuro)	P		P		P	P	P5
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P5
	Small Organ (Thyroid,Breast, Testes, etc.)	P	P	P	P	P	P	p5, 8
	Neonatal Cephalic	P	P	P	P	P	P	p5
Fetal Imaging &Other	Adult Cephalic	P	P	P	P	P	P	P5
	Trans-rectal	P	P	P		P	P	P5
	Trans-vaginal	P	P	P		P	P	p5
	Trans-urethral
	Trans-esoph. (non-Card.)	P	P	P	P	P	P	P5
	Musculo-skel.(Conventional)	P	P	P		P	P	p5,8
	Musculo-skel.(Superficial)	P	P	P		P	P	p5,8
	Intravascular
	Other(3D/4D and Contrast)	P	P	P		P	P
	Cardiac Adult	P1	P	P	P	P	P	p5
	Cardiac Pediatric	P	P	P	P	P	P	P5
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)	P	P	P	P	P	P	P5
	Intra-cardiac	P	P	P	N	P	N
	Other (3D/4D)	P	P	P	P	P	P
	Peripheral Vessel	P	P	P	P	P	P	p5,8
	Other (3D/4D)	P	P	P		P	P

N = new system indication; P = previously cleared by FDA 510(k) K141641

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+CD, B+PW, B+CD+PW, B+M, M+CM, B+CD+M+CM, B+Elastorgraphy, B+CBUS, and

5 Color M-Mode (CM)

8 Freehand tissue elasticity

6 Abdominal includes renal, GYN/Pelvic

7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

PSC Publishing Services (301) 443-6740 BR

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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510(k) Number (if known)

Device Name

System: ZS3and z.oneproUltrasound Systems Transducer: Curvilinear Transducer C4-1

Indications for Use (Describe)

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

Clinical Application	Mode of Operation
General(Tracks 1 Only)	Specific(Track I & III)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other5, 8
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P
	Abdominal6	P	P	P	P	P	P
	Intra-operative(Specify)7
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P
	Pediatric Aux
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
	Adult Cephalic
Fetal Imaging &Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)	P	P	P		P
	Musculo-skel.(Superficial)
	Intravascular
	Other (Specify)(3D/4D)contrast	P	P	P		P	P
	Cardiac Adult	P1	P	P	P	P	P
	Cardiac Adult Aux
	Cardiac Pediatric
Cardiac	Cardiac Pediatric Aux
	Trans-esoph. (Cardiac)
	Other (specify) 3D/4D
	Other (intra-cardiac)*
	Peripheral Vessel
Peripheral Vessel	Peripheral Vessel Aux
	Other (Specify) 3D/4D

N = new indication; P=previously cleared by FDA 510(k) K141641

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)

Includes Color Dopper (OD), Directional Privation Percent (CD, Della represent (CD, DPD, PD, or BD)

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

1 -

1 ... 11

-- | | | | | | | | |

. 11

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$10(k) Number (if known)

Device Name

System: ZS3and z.oneproUltrasound Systems Transducer: Curvilinear Transducer C6-2

Indications for Use (Describe)

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other5, 8
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P5
	Abdominal6	P	P	P		P	P	P5
	Intra-operative(Specify)
	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-skel.(Conventional)
	Musculo-skel.(Superficial)
	Intravascular
	Other (Specify) (3D/4D)
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
	Peripheral Vascular	P	P	P		P	P	P5
Peripheral Vessel	Other (Specify)

N = new indication; P=previously cleared by FDA 510(k) K141641

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

? Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

1 :.. : 1

.. I

1 1.1

$10(k) Number (if known)

Unknown

Device Name

System: ZS3and z.oneproUltrasound Systems Transducer: Curvilinear Transducer C9-3

Indications for Use (Describe)

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

Clinical Application	Mode of Operation
	Specific(Tracks 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other5, 8
General(Track 1 Only)	Ophthalmic
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	P	P	P		P	P	P5
	Abdominal6	P	P	P		P	P	P5
	Intra-operative(Abdominal)	P	P	P		P	P	P5
	Intra-operative(Vascular)	P	P	P		P	P	P5
	LaparoscopicPediatric	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-skel.(Conventional)	P	P	P		P	P	P5
	Musculo-skel.(Superficial)	P	P	P		P	P	P5
	Intravascular
	Other (Specify) (3D/4D)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral Vessel	Peripheral Vascular	P	P	P		P	P	P5
	Other (Specify)

N = new indication; P=previously cleared by FDA 510(k) K141641

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)

Includes B+M, B+M+CM, M+CM, B+CD+PW+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 abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

FORM FDA 3881 (8/14)

5 OF 21

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

0(k) Number (if known)

Device Name

System: ZS3and z.oneproUltrasound Systems Transducer: Phased (Sector) Array Transducer C10-3

Indications for Use (Describe)

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

Clinical Application		Mode of Operation
General(Track 1)	Specific(Tracks I & III)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other5, 8
Ophthalmic	Ophthalmic	P		P		P	P
	Fetal	P	P	P	P	P	P	P5
Fetal Imaging &Other	Abdominal6	P	P	P	P	P	P	P5
	Intra-operative (specify)	P	P	P		P	P	P5
	Intra-operative (Neuro)	P	P	P		P	P	P5
	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-skel.(Conventional)
	Musculo-skel.(Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult	P	P	P	P	P	P	P5
	Cardiac Pediatric	P	P	P	P	P	P	P5
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)(3D/4D)
Peripheral Vessel	Peripheral Vascular	P	P	P	P	P	P	P5
	Other (Specify) 3D/4D

N = new indication; P=previously cleared by the FDA 510(k) K141641

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)

1 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 abdominal, thoracic (cardiac) and vascular (PV)

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

0(k) Number (if known)

Device Name

System: ZS3and z.oneproUltrasound Systems Transducer: Curvilinear Transducer C8-3 (3D)

Indications for Use (Describe)

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

Clinical Application	Mode of Operation
General(Track 1)	Specific(Tracks 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other5
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P5
	Abdominal6	P	P	P		P	P	P5
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P5
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)
	Musculo-skel.(Superficial)
	Intravascular
	Other (Specify) (3D/4D)	P	P	P		P	P	P5
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
	Peripheral Vascular	P	P	P		P	P	P5
Peripheral Vessel	Other (Specify)

N = new indication; P=previously cleared by FDA 510(k) K141641

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)

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 abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

FORM FDA 3881 (8/14)

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

0(k) Number (if known)

Device Name

System: ZS3and z.onemoUltrasound Systems Transducer: Phase (Sector) Array Transducer P4-1c

Indications for Use (Describe)

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

Clinical Application		Mode of Operation
	Specific(Tracks 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other5
General(Track 1 Only)	Ophthalmic							8
Ophthalmic	Fetal	P	P	P	P	P	P	P5
	Abdominal6	P	P	P	P	P	P	P5
	Intra-operative(Specify)
	Intra-operative (Neuro)
	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-skel.(Conventional)
	Musculo-skel.(Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult	P1	P	P	P	P	P	P5
	Cardiac Pediatric	P	P	P	P	P	P	P5
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)(3D/4D)contrast	P	P	P		P	P	P5
Peripheral Vessel	Peripheral Vascular	P	P	P	P	P	P	P5
	Other (Specify)

N = new indication; P=previously cleared by the FDA 510(k) K141641

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)

" 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 abdominal, thoracic (cardiac) and vascular (PV)

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

0(k) Number (if known)

Device Name

System: ZS3and z.oneproUltrasound Systems

Gystelli 2004 2:00 PM 210 Blectronics Co., Ltd. Model #V11-3BE Transducer (off-the-shelf) (Endo-Cavity Transducer E9-3)

Indications for Use (Describe)

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

Clinical Application	Mode of Operation
General	Specific	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other5, 8
(Track I Only)	(Track I & III)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P5
	Abdominal
	Intra-operative(Specify)7
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
Generalapplication	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-skel.(Conventional)
	Musculo-skel.(Superficial)
	Intravascular
	Other (Specify)(3D/4D)
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
	Peripheral vascular
Peripheral vascular	Other (Specify)

N = new indication; P-previously cleared by FDA 510(k) K141641

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 abdominal, thoracic (cardiac) and vascular (PV)

Freehand tissue elasticity

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

10(k) Number (if known)

Device Name

System: ZS3and z.onewoUltrasound Systems Transducer: Endo-Cavity Transducer E9-4

Indications for Use (Describe)

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

Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other5, 8
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P5
	Abdominal
	Intra-operative(Specify)7
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
Fetal Imaging &Other	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-skel.(Conventional)
	Musculo-skel.(Superficial)
	Intravascular
	Other (Specify)(3D/4D)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-Cardiac
	Other (Specify)
	Peripheral vascular
Peripheral Vessel	Other (Specify)

N = new indication; P=previously cleared by FDA 510(k) K141641

I 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 abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

10 OF 21

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. -

11:11

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------…!

--- | 补水

-I

1111

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

0(k) Number (if known)

Device Name

System: ZS3and Z.oneproUltrasound Systems Transducer: Endo-Cavity Transducer E9-3 (3D)

Indications for Use (Describe)

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

Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD2	CWD	ColorDoppler	CombinedModes4	Other5, 8
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	P	P	P		P	P	P5
	Abdominal
	Intra-operative(Specify)7
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Thyroid,Breast, Testes, etc.)
	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-skel.(Conventional)
	Musculo-skel.(Superficial)
	Intravascular
	Other (Specify)(3D/4D)	P	P	P		P	P	P5
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
	Peripheral vascular
Peripheral Vessel	Other (Specify)

N = new indication; P=previously cleared by FDA 510(k) K141641

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)

1 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 abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

11 OF 21

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. . ..

0(k) Number (if known)

Device Name

System: ZS3and z.onenroUltrasound Systems Transducer: Linear Transducer L10-5

Indications for Use (Describe)

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

Clinical Application	Mode of Operation
General(Track I Only)	Specific(Tracks 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other5, 8
Ophthalmic	Ophthalmic	P	P	P	P	P	P	P5
	Fetal	P	P	P	P	P	P	P5
	Abdominal6	P	P	P	P	P	P	P5
	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.)	P	P	P	P	P	P	P5, 8
	Neonatal Cephalic	P	P	P	P	P	P	P5
Fetal Imaging &Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)	P	P	P	P	P	P	P5, 8
	Musculo-skel.(Superficial)	P	P	P	P	P	P	P5, 8
	Intravascular
	Other (Specify)8(3D/4D)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral Vessel	Peripheral Vascular	P	P	P	P	P	P	P5, 8
	Other (Specify)3D/4D

N = new indication; P=previously cleared by the FDA 510(k) K141641

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)

Includes B+M, B+M+CM, M+CM, B+CD+PW+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 abdominal, thoracic (cardiac) and vascular (PV)

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

10(k) Number (if known)

Device Name

System: ZS3and z.oneproUltrasound Systems Transducer: Linear Transducer L8-3

Indications for Use (Describe)

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

Clinical Application	Mode of Operation
	Specific	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other5, 8
General(Track I Only)	(Tracks 1 & 3)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	p5
	Abdominal6	P	P	P	P	P	P	p5
	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.)	P	P	P	P	P	P	p5, 8
	Neonatal Cephalic	P	P	P	P	P	P	p5
	Adult Cephalic
Fetal Imaging &Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)	P	P	P	P	P	P	p5, 8
	Musculo-skel.(Superficial)	P	P	P	P	P	P	p5, 8
	Intravascular
	Other (Specify)83D/4D
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
	Peripheral Vascular	P	P	P	P	P	P	p5p8
Peripheral Vessel	Other (Specify)3D/4D

N = new indication; P=previously cleared by the FDA 510(k) K141641

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 abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

16-11

-.. !

1 -11

::::

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

0(k) Number (if known)

Device Name

System: ZS3and z.oneproUltrasound Systems Transducer: Linear Transducer L14-5sp

Indications for Use (Describe)

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	Other5, 8
Ophthalmic	Ophthalmic	P	P	P	P	P	P
Fetal Imaging &Other	Fetal	P	P	P	P	P	P	P5
	Abdominal6	P	P	P	P	P	P	P5
	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.)	P	P	P	P	P	P	P5
	Neonatal Cephalic	P	P	P	P	P	P	P5
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)	P	P	P	P	P	P	P5,8
	Musculo-skel.(Superficial)	P	P	P	P	P	P	P5, 8
	Intravascular
	Other (Specify)83D/4D
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral Vessel	Peripheral Vascular	P	P	P	P	P	P	P5
	Other (Specify)3D/4D

N = new indication; P=previously cleared by the FDA 510(k) K141641

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 abdominal, thoracic (cardiac) and vascular (PV)

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

: |

| 中川 ור

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11:11

(0(k) Number (if known)

Device Name

System: ZS3and z.oneproUltrasound Systems Transducer: Linear Transducer L14-5w

Indications for Use (Describe)

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other5, 8
Ophthalmic	Ophthalmic	P	P	P		P	P
Fetal Imaging &Other	Fetal	P	P	P		P	P	P5
	Abdominal6	P	P	P		P	P	P5
	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	P8
	Neonatal Cephalic	P	P	P		P	P	P5
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)	P	P	P		P	P	P5, 8
	Musculo-skel.(Superficial)	P	P	P		P	P	P5,8
Cardiac	Intravascular (Cardiac)
	Other (Specify)83D/4D
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral Vessel	Peripheral Vascular	P	P	P		P	P	P5P8
	Other (Specify)3D/4D

N = new indication; P=previously cleared by the FDA 510(k) K141641

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 abdominal, thoracic (cardiac) and vascular (PV)

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

0(k) Number (if known)

Device Name

System: ZS3and z.oneproUltrasound Systems Transducer: Linear Transducer L20-5

Indications for Use (Describe)

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other5, 8
Ophthalmic	Ophthalmic	P		P		P	P
	Fetal	P	P	P		P	P	p5
	Abdominal6	P	P	P		P	P	p5
	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
	Neonatal Cephalic	P	P	P		P	P	p5
Fetal Imaging &Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)	P	P	P		P	P	p5, 8
	Musculo-skel. (Superficial)	P	P	P		P	P	p5, 8
	Intravascular
	Other (Specify)83D/4D
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral Vessel	Peripheral Vascular	P	P	P		P	P	p5
	Other (Specify)3D/4D							p8

N = new indication; P=previously cleared by the FDA 510(k) K141641

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 abdominal, thoracic (cardiac) and vascular (PV)

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

0(k) Number (if known)

Device Name

System: ZS3and z.oneproUltrasound Systems Transducer: Tran-Esophageal Transducer: P8-3TEE

Indications for Use (Describe)

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other 5, 8
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Specify)?
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)	P	P	P	P	P	P	P5
	Musculo-skel.(Conventional)
	Musculo-skel.(Superficial)
	Intravascular
	Other (Specify)(3D/4D)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)	P	P	P	P	P	P	P5
	Intra-cardiac
	Other (Specify)
	Peripheral Vessel
Peripheral Vessel	Other (Specify)

N = new indication; P=previously cleared by FDA 510(k) K141641

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 abdominal, thoracic (cardiac) and vascular (PV)

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

0(k) Number (if known)

Device Name

System: ZS3and z.oneproUltrasound Systems

Dyatem: 205and 2.000px 21:00 PM 2019 Catheter model # VF-PM Part #09-2005 (off the shelf) (P9-3ic)

Indications for Use (Describe)

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

	Clinical Application =========================================================================================================================================================
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other 5, 8
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Specify)'
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
	Adult Cephalic
Fetal Imaging &	Trans-rectal
Other	Trans-vaginal
	Trans-urethral
	Trans-esoph, (non-
	Card.)
	Musculo-skel.
	(Conventional)
	Musculo-skel.
	(Superficial)
	Intravascular
	Other (Specify)
	(3D/4D)
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)	P	P	P	P	P	P
	Peripheral vascular
Peripheral Vessel	Other (Specify)

N = new indication; P=previously cleared by FDA 510(k) K141641, St Jude K031066 & K073709;

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)

1 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 abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

11 11

| ·

1 . . . !!

| … ::

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

1141

....

1 .. 1111

0(k) Number (if known)

Device Name

System: ZS3and z.oneproUltrasound Systems Transducer: A2CW (Common name Pencil Probe)

Indications for Use (Describe)

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Specify)7
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric				P
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
	Adult Cephalic
Fetal Imaging &Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel(Conventional)
	Musculo-skel(Superficial)
	Intravascular
	Intra-luminal
	Other (Specify)(3D/4D)
	Cardiac Adult				P
	Cardiac Pediatric				P
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Intra-Cardiac)
	Peripheral vascular
	Other (Specify)
Peripheral Vessel

N = new indication; P=previously cleared by FDA 510(k) K141641

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)

³ Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

.. I

1 11.1

114

10(k) Number (if known)

Device Name

System: ZS3and z.oneproUltrasound Systems Transducer: A5CW (Common name Pencil Probe)

Indications for Use (Describe)

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

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other5, 8
	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	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-skel.(Conventional)
	Musculo-skel.(Superficial)
	Intravascular
	Other (Specify)(3D/4D)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Intra-Cardiac)
Peripheral Vessel	Peripheral vascular				P
	Other (Specify)

N = new indication; P=previously cleared by FDA 510(k) K141641

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 abdominal, thoracic (cardiac) and vascular (PV)

FORM FDA 3881 (8/14)

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

0(k) Number (if known)

Device Name

System: ZS3and z.onenroUltrasound Systems Transducer: Curvilinear Transducer C9-3sp

Indications for Use (Describe)

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

Clinical Application	Mode of Operation
General(Track I Only)	Specific(Track I & III)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other5, 8
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	N	N5
	Abdominal	N	N	N	N	N	N	N5
	Intra-operative(Abdominal)7	N	N	N	N	N	N	N5
	Intra-operative(Vascular)	N	N	N	N	N	N	N5
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N5
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
Generalapplication	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)	N	N	N	N	N	N	N5
	Musculo-skel.(Superficial)	N	N	N	N	N	N	N5
	Intravascular
	Other (Specify)(3D/4D)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral vascular	Peripheral vascular	N	N	N	N	N	N	N5
	Other (Specify)

N = new indication; P=previously cleared by FDA 510(k) K141641

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)

Includes Color Doppier (CD), Directional Lond. Bepper (CD could represent (CD, DPD, PD, or BD)

S Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

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Image /page/23/Picture/0 description: The image shows the logo for Zonare. The logo consists of the word "ZONARE" in large, bold, blue letters. Above the word is a graphic of curved lines in shades of blue and purple, arranged in a circular pattern. The logo is simple and modern, with a focus on the company name.

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92 510(k).

General Information

Applicant:	ZONARE Medical Systems, Inc.420 N. Bernardo AvenueMountain View, CA 94043
Contact Person:	Steve GeerdesDirector QA/RAPhone: (650) 316-3106Facsimile: (650) 967-9056E-mail: sgeerdes@zonare.com
Date Prepared:	Revised May 14, 2015
Trade Name(s):	ZS3 Ultrasound Systemz.onepro Ultrasound System
Common Name:	Diagnostic Ultrasound System with Accessories
Classification:	II
ClassificationName(s):	Ultrasonic PulsedDoppler ImagingSystem	Ultrasonic PulsedEcho Imaging System	Diagnostic UltrasoundTransducer
RegulationNumber:	21 CFR 892.1550	892.1560	892.1570
Product Code:	IYN	IYO	ITX
ClassificationPanel:	Radiology
Predicate Devices:	ZONARE's ZS3 Ultrasound System		K150249

Device Description

The exam dependent default settings for the ZS3 allows 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

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based on image appearance preference. The architecture of the ZS3 Ultrasound Platform supports system integration to a variety of upgradable options and features. Up to three ZONARE transducers can be connected to the multi-transducer port permitting easy transducer transition. The ZS3 Ultrasound Platform can be operated on either battery or AC power.

Intended Use

The device is intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal/obstetric, gynecological; Abdominal (renal, GYN/Pelvic; Intra-operative (abdominal, thoracic, and vascular), Intra-operative neurological; Pediatric: small organ (thyroid, breast, testes, etc), Adult & Neonatal Cephalic; Trans-rectal, Trans-cranial, 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 and contrast imaging and Tissue elasticity.

Item	ZS3 Ultrasound PlatformZS3 and z.onepro Ultrasound Systems(ZONARE Medical Systems)	ZS3 Ultrasound platform(ZONARE Medical Systems)
510(k) Number	Current Submission	K150249
Intended Use	Diagnostic ultrasound imaging or fluid flow analysis of thehuman body.	Same
Indications forUse	The z.onepro is intended for use by a qualified physician forultrasound evaluation of Ophthalmic; 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, Trans-vaginal,Trans-cranial, Trans-esophageal (non-cardiac and cardiac);Musculoskeletal (conventional & superficial); 3D/4D; Cardiac- Adult/ Pediatric/ Fetal; Echo, Intra-Cardiac; Pelvic;Peripheral vascular; harmonic tissue and contrast imaging andTissue elasticity.	Same
Design	Diagnostic zone technology ultrasound based platform	Same
Safety Standards	IEC 60601-1IEC 60601-2-37IEC 60601-1-2ISO 10993-1, -5, 10, -12AIUM, NEMA UD 2, NEMA UD3	Same
Patient ContactMaterials	Complies with ISO 10993	Same(However, two materials have been added toE9-4 transducer. Momentive RTV162silicones and Loctite K64481 = Hysol M21-HP colored light gray). Both found to complywith ISO 10993
Mode ofOperations	B-Mode, M-Mode, PWD Mode, CWD, CD Mode,Elastorgraphy, Contrast Enhanced, 3D/4D, ECG (for cardiaccycle referenced timing only) Combined Modes include	Same

Comparison of ZONARE ZS3 Ultrasound Platform to the Predicate Devices

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Item	ZS3 Ultrasound Platform	ZS3 Ultrasound platform
	ZS3 and z.one pro Ultrasound Systems	(ZONARE Medical Systems)
	(ZONARE Medical Systems)
	B+CD, B+PW, B+CD+PW, B+M, M+CM, B+CD+M+CM,B+Elastorgraphy, B+CEUS, and + ECG Trace
Measurements	B-Mode (2D): Depth, Distance, Circ/Area/ Volume	Same
	M-Mode: Depth, Distance, HR
	PWD (Manual): Velocity, Velocity Pairs, RI, Accl, S/D, A/B,
	PI, HR/ PWD (AutoTrace: RI, PI, Accl, S/D, HR, AT, TAMXand TAMN
Principle of	Applying high voltage burst to the Piezoelectric material in the	Same
Operation	transducer and detect reflected echo to construct the diagnostic
	image
Acoustic Output	Track 3:MI, TIS, TIC, TIB (TI Range 0-6.0)	Same
	Derated IspTA: 720mW/cm2 maximum,
	Mechanical Index ≤ 1.9 maximum or Derated IsPPA ≤ 190
	W/cm2 max
	Ophthalmic use:
	TI = Max (TIS as, TIC) ≤ 1;ISPTA.3 < 50mW/cm2; and MI < 0.23
Transducer Types	Linear Array	Same
	Curved Linear Array
	Phased Array
	Trans-esophageal
	Pencil Probe
	Intracavitary
Transducer	1.0 - 20.0 MHz	Same
Frequency

DICOM	Yes	Same
Compliant
Special	Yes	Same
Procedures User
Interface
Display Monitor/	ZS3: Color 19" Liquid Crystal Display (LCD)/ 2 arm	Same
Monitor Arm	articulation plus tilt and swivel
	z.one pro: Color 17" Liquid Crystal Display (LCD)/ Tilt and
	swivel
Scanner	Integrated	Same
Transducer	Multi-Transducer Port (Three)	Same
Port(s)
Dimensions/	Height, max (in operational use) 157.5cm (62in)	Same
Weight	Height, min (in operational use) 128cm (50.5in)Height min (displayed lower for transport) 104cm (41in)
	Width: 51cm (21.1in)
	Depth: 72cm (28.2)
	Weight: 65.3kg (1441b)

Power	100-240V options, ~ 50-60Hz, 6A max	Same
Requirements
Rechargeable	Yes (up to 3.0 hour operation per charge)	Same
Battery
Wireless	Yes (IEEE 802.11b/g, Wi-Fi compliant)	Same

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Item	ZS3 Ultrasound Platform	ZS3 Ultrasound platform(ZONARE Medical Systems)
Capability	ZS3 and z.onepro Ultrasound Systems(ZONARE Medical Systems)

Summary of Non-Clinical Testing Performed:

The ZS3 and z.onewo Ultrasound Systems were tested in accordance with FDA Guidance Document -Manufacturer's Seeking Clearance for Ultrasound Systems and Transducers. The following testing was completed:

Test	Method	Result
Mechanical Verification	In accordance with deviceperformance specifications	PASS
Electrical Safety	In accordance with IEC 60601-1	PASS
EMC Testing	In accordance with IEC 60601-1-2	PASS
Thermal and Acoustic Output	In accordance with IEC 60601-2-37	PASS
Biocompatibility	In accordance with ISO 10993	PASS
Cleaning & Disinfection	In accordance with FDAGuidance Document	PASS
Software Validation &Verification	In accordance with 62304 andFDA Guidance DocumentPrinciples of SoftwareValidation	PASS

NOTE: ZONARE's ZS3 Ultrasound Platform and transducers do not require clinical studies to support the determination of substantial equivalence.

Conclusion

The ZS3 platform system and (Software and Hardware) remain unchanged from the last 510k clearance K150249. The only change with this submission is the addition of new patient contacting materials Listed in comparison chart above. The two materials have been added to E9-4 transducer. Momentive RTV 162 silicones and Loctite K64481 = Hysol M21-HP colored light gray). Both found to comply with ISO 10993. Ultrasound Systems are substantially equivalent in design, intended use. principles of operation, technological characteristics and safety features to ZONARE's ZS3 and zone ultra Ultrasound Systems. There are no new no new issues of safety and/or effectiveness introduced by the modification proposed when used as instructed.

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.