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K Number
K150249
Device Name
ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System
Manufacturer
ZONARE MEDICAL SYSTEMS, INC.
Date Cleared
2015-03-04

(29 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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-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.
More Information

K120703, K141641

ZONARE's ZS3 Ultrasound System K120703, ZONARE'S ZS3 & z.one.proUltrasound System K141641

No
The document does not mention AI, ML, deep learning, or any related terms in the device description, intended use, or performance studies. The focus is on the system's hardware, software control, and patented zone technology for image quality optimization.

No.
The device is described as a "diagnostic ultrasound system" intended for "ultrasound evaluation," which means it is used to acquire and display images for diagnosis, not for treatment.

Yes
The 'Device Description' explicitly states: "The ZS3 and z.onews Ultrasound Systems ... are full-featured, general purpose, software controlled, diagnostic ultrasound systems."

No

The device description explicitly states it is a "full-featured, general purpose, software controlled, diagnostic ultrasound systems" and mentions hardware components like transducers and power options, indicating it is not software-only.

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

Here's why:

  • Intended Use: The intended use clearly states that the device is for "ultrasound evaluation" of various anatomical sites. This involves using ultrasound technology to visualize internal structures of the body.
  • Device Description: The description confirms it's a "diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data."
  • Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis on such specimens. It directly images the body.

Therefore, the ZS3 and z.one PRO Ultrasound Systems are diagnostic imaging devices, not IVDs.

N/A

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-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.

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

IYN, IYO, ITX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Diagnostic ultrasound imaging or fluid flow analysis

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-cranial, Trans-esophageal (non-cardiac and cardiac); Musculosketal (conventional & superficial); Cardiac (Adult/ Pediatric/ Fetal, Echo, Intra-Cardiac); 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.
Testing was completed for Mechanical Verification, Electrical Safety, EMC Testing, Thermal and Acoustic Output, Biocompatibility, Cleaning & Disinfection, and Software Validation & Verification, with all tests passing.
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)

ZONARE's ZS3 Ultrasound System K120703, ZONARE'S ZS3 & z.one.proUltrasound System K141641

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

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

2

(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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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 ApplicationsMode of Operation
General
(Track 1 Only)Specific
(Tracks 1 & 3)BMPWD2CWDColor
Doppler3Combined
Modes4Other4,5
OphthalmicOphthalmicPPPP
FetalPPPPPPP5
AbdominalPPPPPPP5
Intra-operative
(Specify)6PPPPPP5
Intra-operative (Neuro)PPPPP5
Laparoscopic
PediatricPPPPPPP5
Pediatric AuxPP5
Small Organ (Thyroid,
Breast, Testes, etc.)PPPPPPP5
Neonatal CephalicPPPPPPP5
Fetal Imaging &
OtherAdult CephalicPPPPPPP5
Trans-rectalPPPPPP5
Trans-vaginalPPPPPP5
Trans-urethral
Trans-esoph. (non-
Card.)PPPPPPP5
Musculo-skel.
(Conventional)PPPPPP5,8
Musculo-skel.
(Superficial)PPPPPP5,8
Intravascular
Other (Specify)
(3D/4D and Contrast)PPPPP1P3
Cardiac AdultP1PPPPP1P5
Cardiac Adult AuxP
Cardiac PediatricPPPPPPP5
Cardiac Pediatric AuxP
CardiacTrans-esoph. (Cardiac)PPPPPPP5
Other (Specify)
(3D/4D)PPPPPP
Other (Intra-Cardiac)*PPPPPP5
Peripheral VesselPPPPPPP8
Peripheral VesselPeripheral Vessel AuxP
Other (Specify)
(3D/4D)PPPPP

...

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 ApplicationMode of OperationOther3,8
General
(Tracks 1 Only)Specific
(Track I & III)BMPWD2CWDColor
Doppler3Combined
Modes4
OphthalmicOphthalmic
FetalPPPPPP
Abdominal6PPPPPP
Intra-operative
(Specify)7
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPP
Pediatric Aux
Small Organ (Thyroid,
Breast, Testes, etc.)
Neonatal Cephalic
Adult Cephalic
Fetal Imaging &
OtherTrans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-
Card.)
Musculo-skel.
(Conventional)PPPP
Musculo-skel.
(Superficial)
Intravascular
Other (Specify)
(3D/4D)PPPPP
contrast
Cardiac AdultP1PPPPP
Cardiac Adult Aux
Cardiac Pediatric
CardiacCardiac Pediatric Aux
Trans-esoph. (Cardiac)
Other (specify) 3D/4D
Other (intra-cardiac) *
Peripheral Vessel
Peripheral VesselPeripheral 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.

. .

88

3 ... ::

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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 ApplicationMode of Operation
General
(Track 1 Only)Specific
(Tracks 1 & 3)BMPWD2CWDColor
Doppler3Combined
Modes4Other5, 8
OphthalmicOphthalmic
FetalPPPPPP5
Abdominal6PPPPPP5
Intra-operative
(Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPP5
Small Organ (Thyroid,
Breast, Testes, etc.)
Neonatal Cephalic
Fetal Imaging &
OtherAdult 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
CardiacIntravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral VascularPPPPPP5
Peripheral VesselOther (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)

21

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 ApplicationMode of Operation
General
(Track 1 Only)Specific
(Tracks 1 & 3)BMPWD2CWDColor
Doppler3Combined
Modes4Other5, 8
OphthalmicOphthalmic
FetalPPPPPPP5
Abdominal6PPPPPPP5
Intra-operative
(Abdominal)PPPPPPP5
Intra-operative
(Vascular)PPPPPPP5
Laparoscopic
PediatricPPPPPPP5
Small Organ (Thyroid,
Breast, Testes, etc.)
Neonatal Cephalic
Fetal Imaging &
OtherAdult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-
Card.)
Musculo-skel,
(Conventional)PPPPPP5
Musculo-skel.
(Superficial)PPPPPP5
Intravascular
Other (Specify) (3D/4D)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
CardiacTrans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral VascularPPPPPP5
Peripheral VesselOther (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

: '.

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 ApplicationMode of Operation
General
(Track 1)Specific
(Tracks I & III)BMPWD2CWDColor
Doppler3Combined
Modes4Other5, 6
OphthalmicOphthalmicPPPP
FetalPPPPPPP5
Abdominal6PPPPPPP5
Intra-operative (specify)PPPPPP5
Intra-operative (Neuro)PPPPPP5
Laparoscopic
PediatricPPPPPPP5
Small Organ (Thyroid,
Breast, Testes, etc.)
Neonatal CephalicPPPPPPP3
Fetal Imaging &
OtherAdult Cephalic/ trans
cranialPPPPPPP5
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-
Card.)
Musculo-skel.
(Conventional)
Musculo-skel.
(Superficial)
Intravascular
Other (Specify)P5
Cardiac AdultPPPPPPP5
Cardiac PediatricPPPPPPP5
Intravascular (Cardiac)
CardiacTrans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
(3D/4D)P5
Peripheral VascularPPPPPPP5
Peripheral VesselOther (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 ApplicationMode of Operation
General
(Track 1)Specific
(Tracks 1 & 3)BMPWD2CWDColor
Doppler3Combined
Modes4Other5
OphthalmicOphthalmic
FetalPPPPPP5
Abdominal6PPPPPP5
Intra-operative
(Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPP5
Small Organ (Thyroid,
Breast, Testes, etc.)
Neonatal Cephalic
Fetal Imaging &
OtherAdult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-
Card.)
Musculo-skel.
(Conventional)
Musculo-skel.
(Superficial)
Intravascular
Other (Specify) (3D/4D)PPPPPP5
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
CardiacTrans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral VascularPPPPPP5
Peripheral VesselOther (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 ApplicationMode of Operation
General
(Track I Only)Specific
(Tracks 1 & 3)BMPWD2CWDColor
Doppler3Combined
Modes4Other5
OphthalmicOphthalmic
Fetal Imaging &
OtherFetalPPPPPPP1
Abdominal6PPPPPPP5
Intra-operative
(Specify)7
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPP5
Small Organ (Thyroid,
Breast, Testes, etc.)
Neonatal CephalicPPPPPPP5
Adult Cephalic/ trans
cranialPPPPPPP5
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-
Card.)
Musculo-skel.
(Conventional)
Musculo-skel.
(Superficial)
Intravascular
Other (Specify)
CardiacCardiac AdultP1PPPPPP5
Cardiac PediatricPPPPPPP5
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
(3D/4D)contrastPPPPPP5
Peripheral VesselPeripheral VascularPPPPPPP5
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

  1. 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 ApplicationMode of Operation
General
(Track I Only)Specific
(Track I & III)BMPWD2CWDColor
Doppler3Combined
Modes4Other5, 8
OphthalmicOphthalmic
General
applicationFetalPPPPPP5
Abdominal
Intra-operative
(Specify)7
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Thyroid,
Breast, Testes, etc.)
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPPP5
Trans-vaginalPPPPPP5
Trans-urethral
Trans-esoph. (non-
Card.)
Musculo-skel.
(Conventional)
Musculo-skel.
(Superficial)
Intravascular
Other (Specify)
(3D/4D)
CardiacCardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vascularPeripheral 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)

gr

11

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 ApplicationMode of OperationOther⁵
General
(Track 1 Only)Specific
(Tracks 1 & 3)BMPWD²CWDColor
Doppler³Combined
Modes⁴
OphthalmicOphthalmic
FetalPPPPPp³
Abdominal
Intra-operative
(Specify)⁷
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Thyroid,
Breast, Testes, etc.)
Neonatal Cephalic
Adult Cephalic
Fetal Imaging &
OtherTrans-rectalPPPPPp³
Trans-vaginalPPPPPp³
Trans-urethral
Trans-esoph. (non-
Card.)
Musculo-skel.
(Conventional)
Musculo-skel.
(Superficial)
Intravascular
Other (Specify)
(3D/4D)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
CardiacTrans-esoph. (Cardiac)
Intra-Cardiac
Other (Specify)
Peripheral vascular
Other (Specify)
Peripheral VesselOther (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 :: :|

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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 ApplicationMode of Operation
General
(Track 1 Only)Specific
(Tracks 1 & 3)BMPWD2CWDColor
Doppler3Combined
Modes4Other5, 8
OphthalmicOphthalmic
Fetal Imaging &
OtherFetalPPPPPP5
Abdominal
Intra-operative
(Specify)7
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Thyroid,
Breast, Testes, etc.)
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPPP5
Trans-vaginalPPPPPP5
Trans-urethral
Trans-esoph. (non-
Card.)
Musculo-skel.
(Conventional)
Musculo-skel.
(Superficial)
Intravascular
Other (Specify)
(3D/4D)PPPPPP5
CardiacCardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral VesselPeripheral 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 ApplicationMode of Operation
General
(Track I Only)Specific
(Tracks 1 & 3)BMPWD1CWDColor
Doppler2Combined
Modes3Others5, 8
OphthalmioOphthalmicPPPPPP5
FetalPPPPPP5
Abdominal6PPPPPP5
Intra-operative
(Specify)7PPPPPP5
Intra-operative (Neuro)PPPPPP5
Laparoscopic
PediatricPPPPPP5
Small Organ (Thyroid,
Breast, Testes, etc.)PPPPPP5
Neonatal CephalicPPPPPP5
Adult Cephalic
Fetal Imaging &
OtherTrans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-
Card.)
Musculo-skel.
(Conventional)PPPPPP5,8
Musculo-skel.
(Superficial)PPPPPP5,8
Intravascular
Other (Specify)8
(3D/4D)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
CardiacTrans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral VascularPPPPPP5,8
Peripheral VesselOther (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 | CWD | Color
Doppler3 | Combined
Modes4 | 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)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 |
| 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

BE

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

| … !!

1 - :

.. | + }

:

. İ

:: --

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 ApplicationMode of OperationOther5, 8
General
(Track 1 Only)Specific
(Track 1 & 3)BMPWD2CWDColor
Doppler3Combined
Modes4
OphthalmicOphthalmicPPPPPP
Fetal Imaging &
OtherFetalPPPPPPP5
AbdominalPPPPPPP5
Intra-operative
(Specify)7PPPPPPP5
Intra-operative (Neuro)PPPPPPP5
Laparoscopic
PediatricPPPPPPP5
Small Organ (Thyroid,
Breast, Testes, etc.)PPPPPPP5
Neonatal CephalicPPPPPPP5
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-
Card.)
Musculo-skel.
(Conventional)PPPPPPP5,8
Musculo-skel.
(Superficial)PPPPPPP5,8
Intravascular
Other (Specify)8
3D/4D
CardiacCardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral VascularPPPPPPP5
Peripheral VesselOther (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 ApplicationMode of Operation
SpecificBMPWD2CWDColor
Doppler3Combined
Modes4Other5, 8
General
(Track 1 Only)Ophthalmic
Fetal Imaging &
OtherOphthalmicPPPPPP5
FetalPPPPPP5
Abdominal6PPPPPP5
Intra-operative
(Specify)7PPPPPP5
Intra-operative (Neuro)PPPPPP5
Laparoscopic
PediatricPPPPPP5
Small Organ (Thyroid,
Breast, Testes, etc.)PPPPPP5
Neonatal CephalicPPPPPP5
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-
Card.)
Musculo-skel.
(Conventional)PPPPPP5, 8
Musculo-skel.
(Superficial)PPPPPP5, 8
Intravascular (Cardiac)
Other (Specify)8
3D/4D
CardiacCardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral VesselPeripheral VascularPPPPPP5
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 ApplicationMode of OperationOther5, 8
General
(Track 1 Only)Specific
(Tracks 1 & 3)BMPWD2CWDColor
Doppler3Combined
Modes4
OphthalmicOphthalmicPPPP
Fetal Imaging &
OtherFetalPPPPPP5
Abdominal6PPPPPP5
Intra-operative (Specify)7PPPPPP5
Intra-operative (Neuro)PPPPP5
Laparoscopic
PediatricPPPPPP5
Small Organ (Thyroid,
Breast, Testes, etc.)PPPPPP5
Neonatal CephalicPPPPPP5
Fetal Imaging &
OtherAdult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel.
(Conventional)PPPPPP5,8
Musculo-skel. (Superficial)PPPPPP5,8
Intravascular
Other (Specify)8
3D/4D
CardiaoCardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral VesselPeripheral VascularPPPPPP5
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 ApplicationMode of Operation
PWD2CWDColorCombinedOther5, 8
General
(Track 1 Only)Specific
(Tracks 1 & 3)BMDopplerModes4
OphthalmicOphthalmic
Fetal
Abdominal
Intra-operative
(Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Thyroid,
Breast, Testes, etc.)
Neonatal Cephalic
Fetal Imaging &
OtherAdult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-
Card.)PPPPPPP5
Musculo-skel.
(Conventional)
Musculo-skel.
(Superficial)
Intravascular
Other (Specify)
(3D/4D)
Cardiac Adult
Cardiac Pediatric
CardiacIntravascular (Cardiac)
Trans-esoph. (Cardiac)PPPPPPP5
Intra-cardiac
Other (Specify)
Peripheral Vessel
Peripheral VesselOther (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 ApplicationMode of Operation
General
(Track 1 Only)Specific
(Tracks 1 & 3)BMPWD2CWDColor
Doppler3Combined
Modes4Other4,5
OphthalmicOphthalmic
Fetal
Abdominal
Intra-operative
(Specify)7
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Thyroid,
Breast, Testes, etc.)
Neonatal Cephalic
Fetal Imaging &
OtherAdult 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
CardiacIntravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiacPPPP
Other (Specify)PP
Peripheral vascular
Peripheral VesselOther (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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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 ApplicationMode of Operation
General
(Track 1 Only)Specific
(Tracks 1 & 3)BMPWD2CWDColor
Doppler3Combined
Modes4Other5
OphthalmicOphthalmic
Fetal
Abdominal
Intra-operative
(Specify)7
Intra-operative (Neuro)
LaparoscopicP
Pediatric
Small Organ (Thyroid,
Breast, Testes, etc.)
Neonatal Cephalic
Adult Cephalic
Fetal Imaging &
OtherTrans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-
Card.)
Musculo-skel.
(Conventional)
Musculo-skel.
(Superficial)
Intravascular
Intra-luminal
Other (Specify)
(3D/4D)
Cardiac AdultP
Cardiac PediatricP
CardiacIntravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Intra-Cardiac)
Peripheral vascular
Peripheral VesselOther (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 ApplicationMode of Operation
General
(Track 1 Only)Specific
(Tracks 1 & 3)BMPWD²CWDColor
Doppler³Combined
Modes⁴Other⁵, ⁸
OphthalmicOphthalmic
Fetal
Abdominal
Intra-operative
(Specify)⁷
Intra-operative (Neuro)
Laparoscopic
PediatricP
Small Organ (Thyroid,
Breast, Testes, etc.)
Neonatal Cephalic
Fetal Imaging &
OtherAdult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-
Card.)
Musculo-skel.
(Conventional)
Musculo-skel.
(Superficial)
Intravascular
Other (Specify)
(3D/4D)
Cardiac Adult
CardiacCardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Intra-Cardiac)
Peripheral VesselPeripheral vascularP
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.

  1. . . . . .

.. |

।

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 ApplicationMode of Operation
General
(Track I Only)Specific
(Track I & III)BMPWD2CWDColor
Doppler3Combined
Modes4Other5, 8
OphthalmicOphthalmic
FetalNNNNNNN5
AbdominalNNNNNNN5
Intra-operative
(Abdominal)7NNNNNNN5
Intra-operative
(Vascular)NNNNNNN5
Laparoscopic
PediatricNNNNNNN5
Small Organ (Thyroid,
Breast, Testes, etc.)
Neonatal Cephalic
General
applicationAdult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-
Card.)
Musculo-skel.
(Conventional)NNNNNNN5
Musculo-skel.
(Superficial)NNNNNNN5
Intravascular
Other (Specify)
(3D/4D)
Cardiac Adult
CardiacCardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vascularPeripheral vascularNNNNNNN5
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

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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 Avenue
Mountain View, CA 94043 | | |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------|-------------------------------------|
| Contact Person: | Steve Geerdes
Director, RA/QA
Phone: (650) 316-3106
Facsimile: (650) 967-9056
E-mail: sgeerdes@zonare.com | | |
| Date Prepared: | October 21, 2014 | | |
| 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 K120703
ZONARE'S ZS3 & z.one.proUltrasound System K141641 | | |

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

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 Ultrasound
Systems |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------|
| 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 60601-1
IEC 60601-2-37
IEC 60601-1-2
ISO 10993-1, -5, 10, -12
AIUM, 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 Trace
B-Mode (2D): Depth, Distance, Circ/Area/ Volume
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 | 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