ZONARE ZS3 Diagnostic Ultrasound System

K151175 · Zonare Medical Systems, Inc. · IYN · May 15, 2015 · Radiology

Device Facts

• Record ID: K151175
• Device Name: ZONARE ZS3 Diagnostic Ultrasound System
• Applicant: Zonare Medical Systems, Inc.
• Product Code: IYN · Radiology
• Decision Date: May 15, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

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.

Device Story

ZS3 and z.onepro are full-featured, software-controlled diagnostic ultrasound systems; utilize patented zone technology to collect data for high-resolution, real-time imaging. Input: ultrasound signals via various transducers (linear, curved, phased, trans-esophageal, pencil, intracavitary). Processing: high-voltage burst applied to piezoelectric material; reflected echoes detected and transformed into diagnostic images. Output: real-time ultrasound images/data displayed on integrated 17" or 19" LCD monitors. Used in clinical settings by qualified physicians. Supports multiple modes: B-mode, M-mode, PWD, CWD, Color Doppler, 3D/4D, contrast-enhanced, and tissue elasticity. System integration includes DICOM compliance, Wi-Fi connectivity, and multi-transducer ports. Benefits: provides high-resolution diagnostic visualization for diverse clinical applications; aids in clinical decision-making through real-time imaging and fluid flow analysis.

Clinical Evidence

Bench testing only. No clinical studies were required to support substantial equivalence. Testing included mechanical verification, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), thermal/acoustic output (IEC 60601-2-37), biocompatibility (ISO 10993), and software validation (IEC 62304).

Technological Characteristics

Diagnostic ultrasound system using zone technology. Transducers: linear, curved, phased, trans-esophageal, pencil, intracavitary. Materials: ISO 10993 compliant (including RTV162 and Loctite K64481). Energy: piezoelectric. Connectivity: DICOM, Wi-Fi (802.11b/g). Power: AC or battery. Software: system-integrated, software-controlled.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including ophthalmic, fetal/obstetric, gynecological, abdominal, intra-operative (abdominal, thoracic, vascular, neuro), pediatric, small organ (thyroid, breast, testes), adult/neonatal cephalic, trans-rectal, trans-vaginal, trans-cranial, trans-esophageal (cardiac/non-cardiac), musculoskeletal (conventional/superficial), cardiac (adult/pediatric/fetal), and peripheral vascular applications.

Regulatory Classification

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.

Predicate Devices

• ZONARE's ZS3 Ultrasound System (K150249)

Submission Summary (Full Text)

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

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

May 15, 2015

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

Re: K151175

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

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [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)

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10(k) Number (if known)

#### Device Name

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

### Indications for Use (Describe)

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

| Clinical Application | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------------------|----|---|------|-----|-------------------|--------------------|-----------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>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<br>(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,<br>Breast, Testes, etc.) | P | P | P | P | P | P | p5, 8 |
| | Neonatal Cephalic | P | P | P | P | P | P | p5 |
| Fetal Imaging &<br>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-<br>Card.) | P | P | P | P | P | P | P5 |
| | Musculo-skel.<br>(Conventional) | P | P | P | | P | P | p5,8 |
| | Musculo-skel.<br>(Superficial) | P | P | P | | P | P | p5,8 |
| | Intravascular | | | | | | | |
| | Other<br>(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.

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510(k) Number (if known)

### Device Name

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

### Indications for Use (Describe)

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

| Clinical Application | Mode of Operation | | | | | | | |
|----------------------------|------------------------------------------------|----|---|------|-----|-------------------|--------------------|-----------|
| General<br>(Tracks 1 Only) | Specific<br>(Track I & III) | B | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other5, 8 |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | P | P | P | |
| | Abdominal6 | P | P | P | P | P | P | |
| | Intra-operative<br>(Specify)7 | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | |
| | Pediatric Aux | | | | | | | |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| Fetal Imaging &<br>Other | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | P | P | P | | P | | |
| | Musculo-skel.<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify)<br>(3D/4D)<br>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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other5, 8 |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | P5 |
| | Abdominal6 | P | P | P | | P | P | P5 |
| | Intra-operative<br>(Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | P5 |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.) | | | | | | | |
| Fetal Imaging &<br>Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | | | | | | | |
| | Musculo-skel.<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) (3D/4D) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Peripheral Vascular | P | P | P | | P | P | P5 |
| Peripheral Vessel | Other (Specify) | | | | | | | |

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

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

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

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

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

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

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

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

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

1 :.. : 1

.. I

1 1.1

----

\$10(k) Number (if known)

#### Unknown

Device Name

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

### Indications for Use (Describe)

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

| Clinical Application | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------------------|---|---|------|-----|-------------------|--------------------|-----------|
| | Specific<br>(Tracks 1 & 3) | B | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other5, 8 |
| General<br>(Track 1 Only) | Ophthalmic | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | P | P | P | | P | P | P5 |
| | Abdominal6 | P | P | P | | P | P | P5 |
| | Intra-operative<br>(Abdominal) | P | P | P | | P | P | P5 |
| | Intra-operative<br>(Vascular) | P | P | P | | P | P | P5 |
| | Laparoscopic<br>Pediatric | P | P | P | | P | P | P5 |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | P | P | P | | P | P | P5 |
| | Musculo-skel.<br>(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

11

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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<br>(Track 1) | Specific<br>(Tracks I & III) | B | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other5, 8 |
| Ophthalmic | Ophthalmic | P | | P | | P | P | |
| | Fetal | P | P | P | P | P | P | P5 |
| Fetal Imaging &<br>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,<br>Breast, Testes, etc.) | | | | | | | |
| | Neonatal Cephalic | P | P | P | P | P | P | P5 |
| | Adult Cephalic/ trans<br>cranial | P | P | P | P | P | P | P5 |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | | | | | | | |
| | Musculo-skel.<br>(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)<br>(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<br>(Track 1) | Specific<br>(Tracks 1 & 3) | B | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other5 |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | P5 |
| | Abdominal6 | P | P | P | | P | P | P5 |
| | Intra-operative<br>(Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | P5 |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging &<br>Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | | | | | | | |
| | Musculo-skel.<br>(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<br>(Tracks 1 & 3) | B | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other5 |
| General<br>(Track 1 Only) | Ophthalmic | | | | | | | 8 |
| Ophthalmic | Fetal | P | P | P | P | P | P | P5 |
| | Abdominal6 | P | P | P | P | P | P | P5 |
| | Intra-operative<br>(Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P5 |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.) | | | | | | | |
| Fetal Imaging &<br>Other | Neonatal Cephalic | P | P | P | P | P | P | P5 |
| | Adult Cephalic/ trans<br>cranial | P | P | P | P | P | P | P5 |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | | | | | | | |
| | Musculo-skel.<br>(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)<br>(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<br>Doppler3 | Combined<br>Modes4 | Other5, 8 |
| (Track I Only) | (Track I & III) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | P5 |
| | Abdominal | | | | | | | |
| | Intra-operative<br>(Specify)7 | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| General<br>application | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | P5 |
| | Trans-vaginal | P | P | P | | P | P | P5 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | | | | | | | |
| | Musculo-skel.<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify)<br>(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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other5, 8 |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | P5 |
| | Abdominal | | | | | | | |
| | Intra-operative<br>(Specify)7 | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging &<br>Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | P5 |
| | Trans-vaginal | P | P | P | | P | P | P5 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | | | | | | | |
| | Musculo-skel.<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify)<br>(3D/4D) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| Cardiac | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-Cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Peripheral vascular | | | | | | | |
| Peripheral Vessel | Other (Specify) | | | | | | | |

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

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

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

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

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

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

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

8 Freehand tissue elasticity

10 OF 21

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

11:11

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

--- | 补水

:

..

-I

1111

-

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

0(k) Number (if known)

### Device Name

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

### Indications for Use (Describe)

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

| Clinical Application | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------------------|---|---|------|-----|------------------|--------------------|-----------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD2 | CWD | Color<br>Doppler | Combined<br>Modes4 | Other5, 8 |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | P | P | P | | P | P | P5 |
| | Abdominal | | | | | | | |
| | Intra-operative<br>(Specify)7 | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Thyroid,<br>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-<br>Card.) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | | | | | | | |
| | Musculo-skel.<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify)<br>(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<br>(Track I Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>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<br>(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,<br>Breast, Testes, etc.) | P | P | P | P | P | P | P5, 8 |
| | Neonatal Cephalic | P | P | P | P | P | P | P5 |
| Fetal Imaging &<br>Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | P | P | P | P | P | P | P5, 8 |
| | Musculo-skel.<br>(Superficial) | P | P | P | P | P | P | P5, 8 |
| | Intravascular | | | | | | | |
| | Other (Specify)8<br>(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)<br>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<br>Doppler3 | Combined<br>Modes4 | Other5, 8 |
| General<br>(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<br>(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,<br>Breast, Testes, etc.) | P | P | P | P | P | P | p5, 8 |
| | Neonatal Cephalic | P | P | P | P | P | P | p5 |
| | Adult Cephalic | | | | | | | |
| Fetal Imaging &<br>Other | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | P | P | P | P | P | P | p5, 8 |
| | Musculo-skel.<br>(Superficial) | P | P | P | P | P | P | p5, 8 |
| | Intravascular | | | | | | | |
| | Other (Specify)8<br>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<br>p8 |
| Peripheral Vessel | Other (Specify)<br>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<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other5, 8 |
| Ophthalmic | Ophthalmic | P | P | P | P | P | P | |
| Fetal Imaging &<br>Other | Fetal | P | P | P | P | P | P | P5 |
| | Abdominal6 | P | P | P | P | P | P | P5 |
| | Intra-operative<br>(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,<br>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-<br>Card.) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | P | P | P | P | P | P | P5,8 |
| | Musculo-skel.<br>(Superficial) | P | P | P | P | P | P | P5, 8 |
| | Intravascular | | | | | | | |
| | Other (Specify)8<br>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)<br>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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other5, 8 |
| Ophthalmic | Ophthalmic | P | P | P | | P | P | |
| Fetal Imaging &<br>Other | Fetal | P…