ZONARE ZS3 Diagnostic Ultrasound System

• K Number: K151175
• Device Name: ZONARE ZS3 Diagnostic Ultrasound System
• Manufacturer: ZONARE MEDICAL SYSTEMS, INC.
• Date Cleared: 2015-05-15 ( 14 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

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.

Predicate Devices

K150249

Reference Devices

St Jude K031066, K073709

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related concepts, and the description focuses on traditional ultrasound technology and image acquisition methods.

Therapeutic

No
The device is described as a "diagnostic ultrasound system" and its intended use is for "ultrasound evaluation," indicating it is used for diagnosis rather than treatment.

Diagnostic

Yes
The "Device Description" explicitly states that the systems are "diagnostic ultrasound systems."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "full-featured, general purpose, software controlled, diagnostic ultrasound systems" and mentions testing including "Mechanical Verification, Electrical Safety, EMC Testing, Thermal and Acoustic Output, Biocompatibility, Cleaning & Disinfection". These are all characteristics of a hardware-based medical device with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The ZS3 and z.one PRO Ultrasound Systems are diagnostic ultrasound systems. They use sound waves to create images of internal body structures. This is an in vivo (within the living body) diagnostic method, not in vitro.
• Intended Use: The intended use clearly describes imaging various anatomical sites within the body.
• Device Description: The description focuses on the ultrasound technology and image acquisition.

Therefore, the ZS3 and z.one PRO Ultrasound Systems fall under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ZS3 and z.one PRO Ultrasound Systems are intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal/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.

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

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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-esophageal (non-cardiac and cardiac); Musculoskeletal (conventional & superficial); Cardiac (Adult/ Pediatric/ Fetal); Pelvic; Peripheral vascular.

Indicated Patient Age Range

Adult, Pediatric, Fetal, Neonatal

Intended User / Care Setting

Qualified physician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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:

• Mechanical Verification: In accordance with device performance 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 FDA Guidance Document (PASS)
• Software Validation & Verification: In accordance with 62304 and FDA Guidance Document Principles of Software Validation (PASS)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K150249

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

St Jude K031066, K073709

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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.

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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"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."

3

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	Color
Doppler3	Combined
Modes4	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 [phone] BR

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

4

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	Color
Doppler3	Combined
Modes4	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

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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	Color
Doppler3	Combined
Modes4	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

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1 1.1

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$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	Color
Doppler3	Combined
Modes4	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
	Laparoscopic
Pediatric	P	P	P		P	P	P5
	Small Organ (Thyroid,
Breast, Testes, etc.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-
Card.)
	Musculo-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	Color
Doppler3	Combined
Modes4	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/ trans
cranial	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	Color
Doppler3	Combined
Modes4	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	Color
Doppler3	Combined
Modes4	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/ trans
cranial	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	Color
Doppler3	Combined
Modes4	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
General
application	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	Color
Doppler3	Combined
Modes4	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

:

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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	Color
Doppler	Combined
Modes4	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	Color
Doppler3	Combined
Modes4	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	Color
Doppler3	Combined
Modes4	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)8
3D/4D
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
	Peripheral Vascular	P	P	P	P	P	P	p5
p8
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

:

l

::::

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	Color
Doppler3	Combined
Modes4	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)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
	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

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

1

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	Color
Doppler3	Combined
Modes4	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)8
3D/4D
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral Vessel	Peripheral Vascular	P	P	P		P	P	P5
P8
	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	Color
Doppler3	Combined
Modes4	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)8
3D/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	Color
Doppler3	Combined
Modes4	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	Color
Doppler3	Combined
Modes4	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						Others, 8
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD2	CWD	Color
Doppler3	Combined
Modes4
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

11

-|

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	Color
Doppler3	Combined
Modes4	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	Color
Doppler3	Combined
Modes4	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
General
application	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)

23

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 Avenue
Mountain View, CA 94043 | | |
|----------------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------------------|-------------------------------------|
| Contact Person: | Steve Geerdes
Director QA/RA
Phone: [phone]
Facsimile: [phone]
E-mail: [e-mail] | | |
| Date Prepared: | Revised May 14, 2015 | | |
| Trade Name(s): | ZS3 Ultrasound System
z.onepro Ultrasound System | | |
| Common Name: | Diagnostic Ultrasound System with Accessories | | |
| Classification: | II | | |
| Classification
Name(s): | Ultrasonic Pulsed
Doppler Imaging
System | Ultrasonic Pulsed
Echo Imaging System | Diagnostic Ultrasound
Transducer |
| Regulation
Number: | 21 CFR 892.1550 | 892.1560 | 892.1570 |
| Product Code: | IYN | IYO | ITX |
| Classification
Panel: | Radiology | | |
| Predicate Devices: | ZONARE's ZS3 Ultrasound System | | K150249 |

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.

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
ZS3 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 the
human body. | 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 |
  | Design | Diagnostic zone technology ultrasound based platform | Same |
  | Safety Standards | IEC 60601-1
  IEC 60601-2-37
  IEC 60601-1-2
  ISO 10993-1, -5, 10, -12
  AIUM, NEMA UD 2, NEMA UD3 | Same |
  | Patient Contact
  Materials | Complies with ISO 10993 | Same
  (However, two materials have been added to
  E9-4 transducer. Momentive RTV162
  silicones and Loctite K64481 = Hysol M21-
  HP colored light gray). Both found to comply
  with ISO 10993 |
  | 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 | Same |

Comparison of ZONARE ZS3 Ultrasound Platform to the Predicate Devices

25

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, TAMX
and 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