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-rectal, Trans-vaginal, Trans-cranial, Trans-esophageal (non-cardiac and cardiac); Musculosketal (conventional & superficial); 3D/4D; Cardiac - Adult/ Pediatric/ Fetal; Echo, Intra-Cardiac; Pelvic; Peripheral vascular; harmonic tissue and contrast imaging and Tissue elasticity.

Device Description

The ZS3 and z.onews 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.

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 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.

AI/ML Overview

This document describes the ZS3 and z.onepro Ultrasound Systems and their transducers, stating they are substantially equivalent to previously cleared devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria from an AI performance perspective, as it is a 510(k) submission for an ultrasound system, not an AI/ML device.

However, I can extract information related to the general device performance and testing completed to ensure its safety and effectiveness, which serves as a form of acceptance criteria for a medical device regulatory submission.

Here's a summary of the non-clinical testing performed for the ZS3 and z.onepro Ultrasound Systems, which implicitly demonstrates their compliance with established standards:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission for an ultrasound system, the "acceptance criteria" are embodied by compliance with recognized medical device standards and the device performance specifications as demonstrated through non-clinical testing. The "device performance" refers to the system passing these tests.

Acceptance Criteria (Test)	Reported Device Performance (Result)
Mechanical Verification	PASS
Electrical Safety (IEC 60601-1)	PASS
EMC Testing (IEC 60601-1-2)	PASS
Thermal and Acoustic Output (IEC 60601-2-37)	PASS
Biocompatibility (ISO 10993)	PASS
Cleaning & Disinfection (FDA Guidance)	PASS
Software Validation & Verification (62304 & FDA Guidance)	PASS

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

This document describes non-clinical testing of a hardware and software system, not an AI/ML algorithm that processes a "test set" of patient data. Therefore, the concept of "sample size for the test set" and "data provenance" in the context of clinical data does not apply here. The testing was carried out through standard engineering and laboratory methods on the physical device and its software.

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

This is not applicable as the submission concerns a physical medical device (ultrasound system) and its compliance with engineering and safety standards, not the diagnostic accuracy of an AI algorithm evaluated against expert consensus. The "ground truth" for these tests are the established standards and specifications themselves.

4. Adjudication method for the test set:

Not applicable for a non-clinical device safety and performance evaluation.

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:

Not applicable. This is a submission for an ultrasound system, not an AI-assisted diagnostic tool. No MRMC study or AI performance evaluation is mentioned.

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

Not applicable as this is a medical device (ultrasound system) submission and not an AI algorithm.

7. The type of ground truth used:

For the non-clinical testing described, the "ground truth" is defined by:

Engineering specifications and device performance requirements: These are internal standards set by the manufacturer for the device's functionality.
International and national standards: Such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993, and EN 62304.
FDA Guidance Documents: For cleaning & disinfection and software validation.

8. The sample size for the training set:

Not applicable as this is not an AI/ML algorithm requiring a training set.

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

Not applicable as this is not an AI/ML algorithm requiring a training set.

In summary, this document relates to the regulatory clearance of an ultrasound imaging system as a medical device. The "acceptance criteria" are compliance with established safety, performance, and manufacturing standards, demonstrated through rigorous non-clinical engineering and biological testing. It does not pertain to the performance evaluation of an AI algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line.

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

March 4, 2015

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

Re: K150249

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: February 2, 2015 Received: February 3, 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.

{1}------------------------------------------------

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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(k) Number (if known)

evice Name

ZS3and z.oneproUltrasound Systems

Indications for Use (Describe)

The ZS3 and z.one PRO Ultrasound Systems are intended for use by a qualified physician for ultrasound evaluation of Ophthalmis; I Ite ZS and Z.ME FRO Utrasound Systems and meiner (borning, thoracic, and vascula), intraseries (research), there and climit reurological, Pediatric: small organ (1172 x 110) ... (113 x 110) ... (17 x 15 x 112 x 11 x 14 x 14 x 14 x 14 x 14 x 14 x 14 x 14 x 14 x 11 x 14 x 11 x 14 x 11 x 11 x 11 x 11 Ileuroogical, Fediante, sinan organ (ary cola, creat, conventional & superficial); 3D/4D; Cardiac - Adult/ Pediative Fetal; I rais-cardias; Pelvic; Peripheral vascular; harmonica tissue and contrast imaging and Tissue elasticity,

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.

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

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FORM FDA 3881 (8/14)

{3}------------------------------------------------

510(k) Number (if known)

Device Name

System: ZS3and Z.oneproUltrasound Systems Transducer: System union of all transducer types

Indications for Use (Describe)

Indications for OSe (Deschibe)
Diagnostic ultrasound Imaging or fluid flow analysis of the human body as follows:

Clinical Applications	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other4,5
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
	Pediatric Aux				P			P5
	Small Organ (Thyroid,Breast, Testes, etc.)	P	P	P	P	P	P	P5
	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 (Specify)(3D/4D and Contrast)	P	P	P		P	P1	P3
	Cardiac Adult	P1	P	P	P	P	P1	P5
	Cardiac Adult Aux				P
	Cardiac Pediatric	P	P	P	P	P	P	P5
	Cardiac Pediatric Aux				P
Cardiac	Trans-esoph. (Cardiac)	P	P	P	P	P	P	P5
	Other (Specify)(3D/4D)	P	P	P	P	P	P
	Other (Intra-Cardiac)*	P	P	P		P	P	P5
	Peripheral Vessel	P	P	P	P	P	P	P8
Peripheral Vessel	Peripheral Vessel Aux				P
	Other (Specify)(3D/4D)	P	P	P		P	P

...

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

Includes B-Mode and Harmonic (contrast) imaging (HI)

1 Includes B-Mode imaging and High Pulse Repettion Rate PWD-Mode (HPRF)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD), and Power Doppler

2 Includes PWD-Modelings and High Pulse Repertion National Power Doppler (PD)
3 Includes Color Doptional Power Doptier (DPD), and Power (PD)

3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Force Dopports (D)
4 Includes B+CD, B+PW, B+CD+PW, B+M, M+CM, B+CD+M+CM, B+Elastorgringin and +ECO trace

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

7 Intra operative includes renal, G x N/Felvic
7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

Freezing and tissue crusts

FORM FDA 3881 (8/14)

Page 1 of 1

P&C PublishIng Services (301) 441-6740 ਸਮਾ

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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

$10(k) Number (if known)

Device Name

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

Indications for Use (Describe)

mulcations of Oce (Doombo)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation					Other3,8
General(Tracks 1 Only)	Specific(Track I & III)	B	M	PWD2	CWD	ColorDoppler3		CombinedModes4
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)	P	P	P		P	P
	contrast
	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

I Includes B-Mode and Harmonic (contrast) imaging (HI)

1 Includes B-MOde and Hambate (Journals) integration Rate PWD-Mode (HPRP)
2 Includes PWD-Mode imaging and High Pulse Repeation PDD), and Rouver Download

1 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power (DD), and Power (PD), and

³ Includes Color Doppler (CD), Directional Power Doppel (DFD), and Fower Dopper (21)
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 Frechand tissue elasticity

Preclinical Tissue Gradient

3 OF 21

PSC Publishing Sorvices (301) 443-674D

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

. .

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

$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.)
	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)
	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

I Includes B-Mode and Harmonic (contrast) imaging (HI)

Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)

Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)

Includes Color Doppier (CD), Directional Fower Doppics (DD), and I DWP Lopper (r 2)
4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD

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

FITC-dextran tissue clearing

FORM FDA 3881 (8/14)

Page I of 1

PSC Publishing Services (301) 443-6740 BR

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

$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
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other5, 8
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P5
	Abdominal6	P	P	P	P	P	P	P5
	Intra-operative(Abdominal)	P	P	P	P	P	P	P5
	Intra-operative(Vascular)	P	P	P	P	P	P	P5
	Laparoscopic
	Pediatric	P	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)	P	P	P		P	P	P5
	Musculo-skel.(Superficial)	P	P	P		P	P	P5
	Intravascular
	Other (Specify) (3D/4D)
	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 PDA 510(k) K141641

I Includes B-Mode and Harmonic (contrast) imaging (HI)

Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (IPPR) P

Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)

" Includes Color Doppler (CD), Directional Power (Dr D), and I Photosophia (CD, DPD, PD, or BD)

Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could repressed (CD, DPD,

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

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

4 Freehand tissue elasticity

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740 ER

S OF 21

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

ﻨﺘ

.. . I

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ﻨﺘ

| |

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

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, 6
Ophthalmic	Ophthalmic	P		P		P	P
	Fetal	P	P	P	P	P	P	P5
	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	P3
Fetal Imaging &Other	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)							P5
	Cardiac Adult	P	P	P	P	P	P	P5
	Cardiac Pediatric	P	P	P	P	P	P	P5
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)(3D/4D)							P5
	Peripheral Vascular	P	P	P	P	P	P	P5
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)

· Includes B-Mode and Hathlonic (constally maging (117)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (TPRF)

" Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power (Doppler (PD)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), where CD could represe

³ Includes Color Dopler (CD), Directional Power Doppler (DFD), and Frower Dopper (r Dy

Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or B

S Color M-Mode (CM)

6 Abdominal Includes renal, GYN/Pelvic

· Abdominal includes lenat, C I NA CIVIC
¹ Intra operative include abdominal, thoracic (cardiao) and vascular (PV)

8 Freehand tissue elasticity

ORM FDA 3881 (8/14)

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

6 OF 21

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

0(k) Number (if known)

Device Name

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

Indications for Use (Describe)

maloutions for See (Decriae)
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

Includes B-Mode and Harmonic (contrast) imaging (HI)

Includes B-Mode and Hamonic (Chicker) Intellect Inners (If(IPRF)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (APRF)

1 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power (Dopler (PD)
3 Includes Color Doppler (CD), Directional Power (DPD), and Power (PD)

³ Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppier (12)

Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PW+CM, B+CD+PWD where CD could repressent (CD,

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

· Abdominal Includes leinal, C I N/FCriti
? Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

8 Preehand tissue elasticity

FORM FDA 3881 (8/14)

7 OF 21

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

0(k) Number (if known)

Device Name

System: ZS3and z.oneproUltrasound 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
General(Track I Only)	Specific(Tracks 1 & 3)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other5
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	P	P	P	P	P	P	P1
	Abdominal6	P	P	P	P	P	P	P5
	Intra-operative(Specify)7
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P5
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic	P	P	P	P	P	P	P5
	Adult Cephalic/ transcranial	P	P	P	P	P	P	P5
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-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 Color Doppier (CD), Directorial Politics), BPDJ and Porce CD could represent (CD, DPD, PD, or BD)

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

Abdominal Muscles Toned, C 1107 GYRO

Extra exercises include abdominal, thoracic (central

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

8 Freehand tissue elasticity

8 OF 21

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

(0(k) Number (if known)

Device Name

System: ZS3and z.oneproUltrasound Systems

System: 233and 2.02em Utrasouncs Co., Ltd. Model #V11-3BE Transducer (off-the-shelf) (Endo-Cavity Transducer E9-3)

Indications for Use (Describe)

macations of See (Doombo)
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
Generalapplication	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)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral vascular	Peripheral vascular
	Other (Specify)

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

1 Includes B-Mode and Harmonic (contrast) imaging (HI)

' Includes B-MOde and Halfionic (Collitiatif) imaging (11)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (TPRF)

3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power (Dopler (PD)
3 Includes Color Doppler (CD), Directional Power Doppler (DD) prices CD could repress

1 Includes Color Doppier (CD), Directional Power Doppies (DED), and Ports Countin (CD, DPD, PD, or BD)
4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+M+CM, B+CD+PWD where CD could r

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

Antra operative include abdominal, thoracic (cardiac) and vascular (PV)

8 Frechand tissue elasticity

FORM FDA 3881 (8/14)

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

10(k) Number (if known)

Device Name

....

System: ZS3and z.oneproUltrasound 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					Other⁵
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD²	CWD	ColorDoppler³		CombinedModes⁴
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	p³
	Abdominal
	Intra-operative(Specify)⁷
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
	Adult Cephalic
Fetal Imaging &Other	Trans-rectal	P	P	P		P	P	p³
	Trans-vaginal	P	P	P		P	P	p³
	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
	Other (Specify)
Peripheral Vessel	Other (Specify)

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

Includes B-Mode and Harmonic (contrast) imaging (HI)

1 Includes B-Mode and Hartionic (Contract) integring (PT)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (IPPR)

3 Includes Color Doppler (CD), Directional Power Doppier (DPD), and Power (Doppler (PD)
3 Includes Color Doppler (CD), Directional Power Doption of CD could represses

³ Includes Color Doppler (CD), Directional Power Dopper (DED), and I Dopper (LD)
† Includes B+M, B+M+CM, B+CD+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, P

3 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

Abdominar metades rember inal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

10 OF 21

| | - |

117

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

i :: :|

| … : :

-- । 4-1

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

0(k) Number (if known)

Device Name

System: ZS3and 2.0neproUltrasound 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	ColorDoppler3	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 Vessel	Peripheral vascular

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

1 Includes B-Mode and Harmonic (contrast) imaging (HI)

· Includes B-Mode and Halltonic (contrast) naughts (xx)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)

" Includes Color Doppler (CD), Directional Power (Depler (DPD), and Power Dopler (PD)
3 Includes Color Doppler (CD), Directional Power (Deply, and Power (Dopler (PD)

1 Includes Color Doppier (CD), Directional Power Dopper (DFD), and I one Louis Leagues (2)

Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

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

® Freehand tissue elasticity

FORM FDA 3881 (8/14)

PSC Publishing Boryices (301) 443-6740

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017 See PRA Statement below. __

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

0(k) Number (if known)

Device Name

System; ZS3and z.oneuroUltrasound 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	PWD1	CWD	ColorDoppler2	CombinedModes3	Others5, 8
Ophthalmio	Ophthalmic	P	P	P		P	P	P5
	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	P5
	Neonatal Cephalic	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	P5,8
	Musculo-skel.(Superficial)	P	P	P		P	P	P5,8
	Intravascular
	Other (Specify)8(3D/4D)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
	Peripheral Vascular	P	P	P		P	P	P5,8
Peripheral Vessel	Other (Specify)3D/4D

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

I Includes B-Mode and Harmonic (contrast) imaging (HI)

4 Includes B-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
2 Includes PWD-Mode imaging and High Pulse Repention Rate PWD-Arch

1 Includes Color Doppler (CD), Directional Power Doppler (DDD), and Power (DD)
3 Includes Color Doppler (CD), Directional Power Doppler (DD)), and Power (DD)

1 Includes Color Doppler (CD), Directional Power Dopper (DFD), and I owler Dopper (22)
4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

Abdonimal includes (chai, C x +7) erric

8 Freehand tissue elasticity

Image /page/13/Picture/23 description: The image shows a graph with the title "Soil Temperature vs Time of Day". The graph plots soil temperature on the y-axis and time of day on the x-axis. The graph shows a curve that increases from 6 am to 2 pm, and then decreases from 2 pm to 6 am.

PSC Publishing Services (301) 443-6740 Bir

{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	Specific(Tracks 1 & 3)	B	M	PWD2	ColorDoppler3	CombinedModes4	Other5, 8
General(Track I Only)	Ophthalmic
Ophthalmic	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
Fetal Imaging &Other	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 Vascular	P	P	P	P	P	P5
Peripheral Vessel	Other (Specify)						P8

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

I Includes B-Mode and Harmonic (contrast) imaging (HI)

1 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate POD, and Bower Domb

1 Includes PWD-Mode maging and High Fuse Repear (CBD), and Portions of CDPDF (PD), and Porto Coppler (PD), and Portugion

1 Includes Color Doplier (CD), Directional Power Dopper (DED), and I ones Doppier (CD, DPD, PD, or BD)

Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PW+CM, B+CD+PWD where CD could

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

Abdominal lacitudos reliar, C 1 1 x 1 x 1 x 1 x 1 x 1 vascular (PV)

8 Freehand tissue clasticity

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

| … !!

1 - :

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:: --

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

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					Other5, 8
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD2	CWD	ColorDoppler3		CombinedModes4
Ophthalmic	Ophthalmic	P	P	P	P	P	P
Fetal Imaging &Other	Fetal	P	P	P	P	P	P	P5
	Abdominal	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 Vascular	P	P	P	P	P	P	P5
Peripheral Vessel	Other (Specify)							P8
	3D/4D

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

I Includes B-Mode and Harmonic (contrast) imaging (HI)

Includes B-Mode and Hamonio (contains) and High Pulse Repetition Rate PWD-Modes (RPRF)

includes Color Doppier (CD), Directional Power Doppler (DPD), and Power Doppler (D)

" Includes Color Doppier (CD), Directurial I own Dopper (DB), and Porto Lover Learner (CD, DPD, PD, or BD)
1 Includes B+M, B+CM, B+CD+M+CM, B+CD+PW+CM, B+CD+PWD where CD cou

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

Image /page/15/Picture/17 description: The image shows a simple line drawing of a shape. The shape is roughly rectangular with rounded corners on the right side. The lines are dashed on the top, bottom, and left sides, while the right side is a solid line.

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

(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
	Specific	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other5, 8
General(Track 1 Only)	Ophthalmic
Fetal Imaging &Other	Ophthalmic	P	P	P		P	P	P5
	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	P5
	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
	Intravascular (Cardiac)
	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	P5
	Other (Specify)

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

Includes B-Mode and Harmonic (contrast) imaging (HI)

Includes BWD-Mode imaging and High Pulse Repectition Rate PWD-Mode (HPRP)

3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)

Includes Color Doppier (CD), Directorial Town Doppior (DTD), and Foresent (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)

8 Freehand tissue clasticity

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

ﺍ ﺗﺮ ... ﺍ

: |

ー・イサイト・

ﻢ ﺑﺎﺑﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

ー

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. .

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

10(k) Number (if known)

Device Name

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

Indications for Use (Describe)

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

Clinical Application		Mode of Operation					Other5, 8
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD2	CWD	ColorDoppler3		CombinedModes4
Ophthalmic	Ophthalmic	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	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)8
	3D/4D
Cardiao	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 the FDA 510(k) K141641

I Includes B-Mode and Harmonic (contrast) imaging (HI)

includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (FPRF)
2 Includes PWD-Mode imaging and High Pulse Repetition Raters Derry

් Includes PWL-Mode Imaging Ind Engles Aspendon Rate TWD Today (DTV)
¹ Includes Color Doptier (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
¹ Includes B+M, B

Includes B+M, B+M+C

3 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

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

8 Freehand tissue clasticity

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

0(k) Number (if known)

Device Name

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

Indications for Use (Describe)

maloutierie lor as a maging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
				PWD2	CWD	Color	Combined	Other5, 8
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M			Doppler	Modes4
		Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic
	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
Cardiac	Intravascular (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)

Includes B-MOGE and High Pulse Repetition Rate PWD-Mode (HPRF)
2 Includes PWD-Mode imaging and High Pulse Repetition Rate Perus Democra

1 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (CD), popular (CD), popular (CD), popular (CD), popular (CD), popular paras

1 Includes Color Dopbier (CD), Dittectional Power Doppler (DFD), alle Fower Dopper (1 9
1 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or

5 Color M-Mode (CM)

COLOR LY-Mode (CMY)
6. Abdominal includes range

6 Abdominal includes renal, GYN/Pelvic Abdominal metudes remat, Criat, Criat, Crardiac) and vascular (PV)

8 Frechand tissue elasticity

FORM FDA 3881 (8/14)

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

0(k) Number (If known)

Device Name

System: ZS3and z.oneproUltrasound Systems System: 2552010 2.016-2014 2500115
Transducer: St. Jude EP ViewFlex PLUS ICE Catheter model # VF-PM Part #09-2005 (off the shelf) (P9-3ic)

Indications for Use (Describe)

maloakono for boo (d 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	Other4,5
Ophthalmic	Ophthalmic
	Fetal
	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
	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			P	P	P	P
	Other (Specify)	P	P
	Peripheral vascular
Peripheral Vessel	Other (Specify)

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

Includes B-Mode and Harmonic (contrast) imaging (HI)

2 Includes B-MDBC and Hamonio (ochtran) naught (115) Pulse Repotition Rate PWD-Mode (FIPRF)

Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
Includes Color Doppier (CD), Directional Power Dopplet (DD), and I Phor Doption (PD)
4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DP

5 Color M-Mode (CM)

COLOR M-Mode (Only)
6. Abdominal includes renal

6 Abdominal includes renal, GYN/Pelvic 7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

18 OF 21

.. . . . .

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ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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

10(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	Other5
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Specify)7
	Intra-operative (Neuro)
	Laparoscopic				P
	Pediatric
	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
Peripheral Vessel	Other (Specify)

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

Includes B-Mode and Harmonic (contrast) imaging (HI)

1 Includes B-WD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)
1 Includes PWD-Mode imaging and High Pulse Repetition RDTD and Reward Desum

Includes PWD-Mode Integring and I righ Fulso Reporter (DPD), and Power Doppler (PD)
3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power (CD)
Includes Color Doppier (CD), Directions Power Dopper (Dr D), and Ponto Lopping Project (CD, DPD, PD, or BD)
1 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could repr

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

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

8 Freehand tissue clasticity

Form Approved: OMB No. 0910-0120

. 141. .

Expiration Date: January 31, 2017 See PRA Statement below.

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

0(k) Number (if known)

Device Name

ﮯ، ﺗﮭ

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	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Specify)⁷
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric				P
	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)
	Cardiac Adult
Cardiac	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 PDA 510(k) K141641

1 Includes B-Mode and Harmonic (contrast) imaging (HI)

2 Includes B-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRP)

1 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (DPD)

1 Includes Color Dopbier (CD), Difectional Power Dopper (Dr DJ, alles Form Bopplet (19)
1 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, PD,

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

Abuonninal metudes lemal, en inal croracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

Image /page/21/Picture/17 description: The image shows a simple, hand-drawn illustration of a circle. The circle is not perfectly round, and the lines are somewhat uneven, suggesting it was drawn quickly or without precision. The interior of the circle is mostly empty, with a few faint markings or smudges visible.

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

. . . . .

.. |

।

ﺜ

. .

ﺔ ﺍﻟﻤ

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

10(k) Number (if known)

Device Name

System: ZS3and z.oneproUltrasound 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 Adult
Cardiac	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

I Includes B-Mode and Harmonic (contrast) imaging (HI)

Includes BWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)

3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power (DD)
3 Includes Color Doppler (CD), Directional Power Dopper (DPD), and Power (CD)

' Includes Color Doppier (CD), Directional Fower Dopper (Driver Dopper (DD, DRD, PD, Dr BD)
4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could repressent (CD, DPD, P

S Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

8 Prechand tissue elasticity

21 OF 21

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Image /page/23/Picture/0 description: The image shows the logo for Zonare. The logo consists of a stylized eye-like graphic above the word "ZONARE" in a bold, sans-serif font. The eye graphic is made up of several curved lines in shades of blue and purple, creating a sense of movement and depth. The word "ZONARE" is in a dark blue color, matching the overall color scheme of the logo.

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, RA/QAPhone: (650) 316-3106Facsimile: (650) 967-9056E-mail: sgeerdes@zonare.com
Date Prepared:	October 21, 2014
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 K120703ZONARE'S ZS3 & z.one.proUltrasound System K141641

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

{24}------------------------------------------------

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 Platform(ZONARE Medical Systems)	ZS3(ZONARE Medical Systems)	ZS3 and z.one pro UltrasoundSystems
510(k) Number	Current Submission	K120703	K141641
Intended Use	Diagnostic ultrasound imaging or fluid flow analysis of the human body.	Same	Same
Indications for Use	The z.onepro 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-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 and Tissue elasticity.	Same	Same
Design	Diagnostic zone technology ultrasound based platform	Same	Same
Safety Standards	IEC 60601-1IEC 60601-2-37IEC 60601-1-2ISO 10993-1, -5, 10, -12AIUM, NEMA UD 2, NEMA UD3	Same	Same
Patient Contact Materials	Complies with ISO 10993	Same	Same
Mode of Operations	B-Mode, M-Mode, PWD Mode, CWD, CD Mode, Elastorgraphy, Contrast Enhanced, 3D/4D, ECG (for cardiac cycle referenced timing only)Combined Modes include B+CD, B+PW, B+CD+PW. B+M. M+CM. B+CD+M+CM	Same	Same
Item	ZS3 Ultrasound Platform(ZONARE Medical Systems)	ZS3(ZONARE Medical Systems)	ZS3 and z.onepro Ultrasound Systems
Measurements	B+Elastorgraphy and + ECG TraceB-Mode (2D): Depth, Distance, Circ/Area/ VolumeM-Mode: Depth, Distance, HRPWD (Manual): Velocity, Velocity Pairs, RI, Accl, S/D, A/B, PI, HR/ PWD (AutoTrace: RI, PI, Accl, S/D, HR, AT, TAMX and TAMN	Same	Same
Principle of Operation	Applying high voltage burst to the Piezoelectric material in the transducer and detect reflected echo to construct the diagnostic image	Same	Same
Acoustic Output	Track 3:MI, TIS, TIC, TIB (TI Range 0-6.0)Derated ISPTA: 720mW/cm² maximum,Mechanical Index ≤ 1.9 maximum or Derated ISPPA < 190 W/cm² maxOphthalmic use:TI = Max (TIS_as, TIC) ≤ 1;ISPTA.3 ≤ 50mW/cm2; and MI ≤ 0.23	Same	Same
Transducer Types	Linear ArrayCurved Linear ArrayPhased ArrayTrans-esophagealPencil ProbeIntracavitary	Same	Same
Transducer Frequency	1.0 - 20.0 MHz	Same	Same
DICOM Compliant	Yes	Same	Same
Special Procedures User Interface	Yes	Same	Same
Display Monitor/Monitor Arm	ZS3: Color 19" Liquid Crystal Display (LCD)/ 2 arm articulation plus tilt and swivelz.one pro: Color 17" Liquid Crystal Display (LCD)/ Tilt and swivel	Color 19" Liquid Crystal Display (LCD)/ 2 arm articulation plus tilt and swivel	Same
Scanner	Integrated	Same	Same
Transducer Port(s)	Multi-Transducer Port (Three)	Same	Same
Dimensions/ Weight	Height, max (in operational use) 157.5cm (62in)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 (144lb)	Same	Same
Power Requirements	100-240V options, ~ 50-60Hz, 6A max	Same	same
Rechargeable Battery	Yes (up to 3.0 hour operation per charge)	Same	same
Wireless Capability	Yes (IEEE 802.11b/g, Wi-Fi compliant)	Same	Same

Comparison of ZONARE ZS3 Ultrasound Platform to the Predicate Devices

{25}------------------------------------------------

{26}------------------------------------------------

Image /page/26/Picture/0 description: The image shows the logo for Zonare. The logo consists of a stylized eye-like design above the word "ZONARE" in all capital letters. The eye-like design is made up of several curved lines in shades of blue and purple. The word "ZONARE" is in a bold, sans-serif font and is also in blue.

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 device	PASS
	performance specifications
Electrical Safety	In accordance with IEC 60601-1	PASS
EMC Testing	In accordance with IEC 60601-	PASS
	1-2
Thermal and Acoustic Output	In accordance with IEC 60601-	PASS
	2-37
Biocompatibility	In accordance with ISO 10993	PASS
Cleaning & Disinfection	In accordance with FDA	PASS
	Guidance Document
Software Validation &	In accordance with 62304 and	PASS
Verification	FDA Guidance Document
	Principles of Software
	Validation

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

Conclusion

The ZS3 and z.one, Ultrasound Systems are substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to ZONARE's ZS3 and z.one 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.