ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System

K150249 · Zonare Medical Systems, Inc. · IYN · Mar 4, 2015 · Radiology

Device Facts

• Record ID: K150249
• Device Name: ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System
• Applicant: Zonare Medical Systems, Inc.
• Product Code: IYN · Radiology
• Decision Date: Mar 4, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

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-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 and optimize image quality. Input: reflected ultrasound echoes from piezoelectric transducers. Transformation: high-voltage bursts applied to transducers; reflected signals processed to construct real-time images. Output: high-resolution ultrasound images and fluid flow analysis displayed on integrated LCD monitor. Used in clinical settings by qualified physicians. Supports multiple imaging modes (B-Mode, M-Mode, PWD, CWD, Color Doppler, 3D/4D, contrast, tissue elasticity). Features multi-transducer ports, battery/AC power, and DICOM connectivity. Output assists clinicians in diagnostic evaluation of various anatomical structures and blood flow, potentially improving diagnostic accuracy and patient management.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing, including 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 platform using zone technology. Transducer frequency range: 1.0-20.0 MHz. Modes: B, M, PWD, CWD, Color Doppler, 3D/4D, contrast, tissue elasticity. Connectivity: DICOM, Wi-Fi (IEEE 802.11b/g). Power: AC or battery (up to 3 hours). Patient contact materials comply with ISO 10993. Safety standards: IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2.

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, musculoskeletal, 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 ZS3 Ultrasound System (K120703)
• ZONARE ZS3 & z.one.pro Ultrasound System (K141641)

Reference Devices

• St. Jude EP ViewFlex PLUS ICE Catheter (K031066)
• St. Jude EP ViewFlex PLUS ICE Catheter (K073709)

Submission Summary (Full Text)

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

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

March 4, 2015

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

Re: K150249

Trade/Device Name: ZS3 and z.onepro Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: February 2, 2015 Received: February 3, 2015

Dear Mr. Job:

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

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

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

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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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(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)

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FORM FDA 3881 (8/14)

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510(k) Number (if known)

Device Name

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

#### Indications for Use (Describe)

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

| Clinical Applications | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------------------|----|---|------|-----|-------------------|--------------------|----------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other4,5 |
| Ophthalmic | Ophthalmic | P | | P | | P | P | |
| | Fetal | P | P | P | P | P | P | P5 |
| | Abdominal | P | P | P | P | P | P | P5 |
| | Intra-operative<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 |
| | Pediatric Aux | | | | 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 |
| 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 (Specify)<br>(3D/4D and Contrast) | P | P | P | | P | P1 | P3 |
| | Cardiac Adult | P1 | P | P | P | P | P1 | P5 |
| | Cardiac Adult Aux | | | | P | | | |
| | Cardiac Pediatric | P | P | P | P | P | P | P5 |
| | Cardiac Pediatric Aux | | | | P | | | |
| Cardiac | Trans-esoph. (Cardiac) | P | P | P | P | P | P | P5 |
| | Other (Specify)<br>(3D/4D) | P | P | P | P | P | P | |
| | Other (Intra-Cardiac)* | P | P | P | | P | P | P5 |
| | Peripheral Vessel | P | P | P | P | P | P | P8 |
| Peripheral Vessel | Peripheral Vessel Aux | | | | P | | | |
| | Other (Specify)<br>(3D/4D) | P | P | P | | P | P | |

...

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

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

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

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

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

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

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

8 Freehand tissue elasticity

Freezing and tissue crusts

**FORM FDA 3881 (8/14)**

Page 1 of 1

P&C PublishIng Services [phone] ਸਮਾ

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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#### \$10(k) Number (if known)

#### Device Name

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

#### Indications for Use (Describe)

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

| Clinical Application | | Mode of Operation | | | | | Other3,8 | |
|----------------------------|------------------------------------------------|-------------------|---|------|-----|-------------------|----------|--------------------|
| General<br>(Tracks 1 Only) | Specific<br>(Track I & III) | B | M | PWD2 | CWD | Color<br>Doppler3 | | Combined<br>Modes4 |
| 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) | P | P | P | | P | P | |
| | contrast | | | | | | | |
| | Cardiac Adult | P1 | P | P | P | P | P | |
| | Cardiac Adult Aux | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Cardiac Pediatric Aux | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (specify) 3D/4D | | | | | | | |
| | Other (intra-cardiac) * | | | | | | | |
| | Peripheral Vessel | | | | | | | |
| Peripheral Vessel | Peripheral Vessel Aux | | | | | | | |
| | Other (Specify) 3D/4D | | | | | | | |

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

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

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

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

³ Includes Color Doppler (CD), Directional Power Doppel (DFD), and Fower Dopper (21)
¹ Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

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

8 Frechand tissue elasticity

Preclinical Tissue Gradient

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PSC Publishing Sorvices (301) 443-674D

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

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\$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.) | | | | | | | |
| | 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) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Peripheral Vascular | P | P | P | | P | P | P5 |
| Peripheral Vessel | Other (Specify) | | | | | | | |

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

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

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

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

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

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

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

8 Freehand tissue elasticity

FITC-dextran tissue clearing

FORM FDA 3881 (8/14)

21

Page I of 1

PSC Publishing Services [phone] BR

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#### \$10(k) Number (if known)

#### Unknown

Device Name

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

#### Indications for Use (Describe)

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

| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------------------------|-------------------|---|------|-----|-------------------|--------------------|-----------|
| 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 | P | P5 |
| | Abdominal6 | P | P | P | P | P | P | P5 |
| | Intra-operative<br>(Abdominal) | P | P | P | P | P | P | P5 |
| | Intra-operative<br>(Vascular) | P | P | P | P | P | P | P5 |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | 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) | P | P | P | | P | P | P5 |
| | Musculo-skel.<br>(Superficial) | P | P | P | | P | P | P5 |
| | Intravascular | | | | | | | |
| | Other (Specify) (3D/4D) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| Cardiac | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Peripheral Vascular | P | P | P | | P | P | P5 |
| Peripheral Vessel | Other (Specify) | | | | | | | |

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

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

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

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

" Includes Color Doppler (CD), Directional Power (Dr D), and I Photosophia (CD, DPD, PD, or BD)
* Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could repressed (CD, DPD,

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

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

4 Freehand tissue elasticity

FORM FDA 3881 (8/14)

Page 1 of 1

#### PSC Publishing Services [phone] ER

S OF 21

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

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#### 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, 6 |
| Ophthalmic | Ophthalmic | P | | P | | P | P | |
| | Fetal | P | P | P | P | P | P | P5 |
| | Abdominal6 | P | P | P | P | P | P | P5 |
| | Intra-operative (specify) | P | P | P | | P | P | P5 |
| | Intra-operative (Neuro) | P | P | P | | P | P | P5 |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P5 |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.) | | | | | | | |
| | Neonatal Cephalic | P | P | P | P | P | P | P3 |
| Fetal Imaging &<br>Other | 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) | | | | | | | P5 |
| | Cardiac Adult | P | P | P | P | P | P | P5 |
| | Cardiac Pediatric | P | P | P | P | P | P | P5 |
| | Intravascular (Cardiac) | | | | | | | |
| Cardiac | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify)<br>(3D/4D) | | | | | | | P5 |
| | Peripheral Vascular | P | P | P | P | P | P | P5 |
| Peripheral Vessel | Other (Specify) 3D/4D | | | | | | | |

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

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

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

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

³ Includes Color Dopler (CD), Directional Power Doppler (DFD), and Frower Dopper (r Dy
* Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or B

S Color M-Mode (CM)

6 Abdominal Includes renal, GYN/Pelvic

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

8 Freehand tissue elasticity

ORM FDA 3881 (8/14)

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

6 OF 21

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0(k) Number (if known)

Device Name

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

#### Indications for Use (Describe)

maloutions for See (Decriae)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | Mode of Operation | | | | | | | |
|--------------------------|------------------------------------------------|---|---|------|-----|-------------------|--------------------|--------|
| General<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

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

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

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

³ Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppier (12)
* Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PW+CM, B+CD+PWD where CD could repressent (CD,

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

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

8 Preehand tissue elasticity

FORM FDA 3881 (8/14)

7 OF 21

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

0(k) Number (if known)

#### Device Name

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

### Indications for Use (Describe)

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

| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------------------------|-------------------|---|------|-----|-------------------|--------------------|--------|
| General<br>(Track I Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other5 |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | P | P | P | P | P | P | P1 |
| | Abdominal6 | P | P | P | P | P | P | P5 |
| | Intra-operative<br>(Specify)7 | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | 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 | 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 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

2. Extra exercises include abdominal, thoracic (central

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

8 Freehand tissue elasticity

8 OF 21

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

#### (0(k) Number (if known)

Device Name

System: ZS3and z.oneproUltrasound Systems

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

Indications for Use (Describe)

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

| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------------------------|-------------------|---|------|-----|-------------------|--------------------|-----------|
| General<br>(Track I Only) | Specific<br>(Track I & III) | B | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other5, 8 |
| Ophthalmic | Ophthalmic | | | | | | | |
| General<br>application | 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) | | | | | | | |
| | (3D/4D) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral vascular | Peripheral vascular | | | | | | | |
| | Other (Specify) | | | | | | | |

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

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

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

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

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

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

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

8 Frechand tissue elasticity

FORM FDA 3881 (8/14)

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 Application | | Mode of Operation | | | | | Other⁵ | |
|---------------------------|------------------------------------------------|-------------------|---|------|-----|-------------------|--------|--------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD² | CWD | Color<br>Doppler³ | | Combined<br>Modes⁴ |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | p³ |
| | Abdominal | | | | | | | |
| | Intra-operative<br>(Specify)⁷ | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| Fetal Imaging &<br>Other | Trans-rectal | P | P | P | | P | P | p³ |
| | Trans-vaginal | P | P | P | | P | P | p³ |
| | 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 | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral Vessel | Other (Specify) | | | | | | | |

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

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

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

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

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

3 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

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

8 Freehand tissue elasticity

==

10 OF 21

- | | - |

..

117

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

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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 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 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 Vessel | Peripheral vascular | | | | | | | |

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

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

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

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

1 Includes Color Doppier (CD), Directional Power Dopper (DFD), and I one Louis Leagues (2)
* Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

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

® Freehand tissue elasticity

#### FORM FDA 3881 (8/14)

PSC Publishing Boryices [phone]

Form Approved: OMB No. 0910-0120

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

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

#### 0(k) Number (if known)

#### Device Name

#### System; ZS3and z.oneuroUltrasound Systems Transducer: Linear Transducer L10-5

#### Indications for Use (Describe)

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

| Clinical Application | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------------------|---|---|------|-----|-------------------|--------------------|------------|
| General<br>(Track I Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD1 | CWD | Color<br>Doppler2 | Combined<br>Modes3 | Others5, 8 |
| Ophthalmio | Ophthalmic | P | P | P | | P | P | P5 |
| | Fetal | P | P | P | | P | P | P5 |
| | Abdominal6 | P | P | P | | P | P | P5 |
| | Intra-operative<br>(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,<br>Breast, Testes, etc.) | P | P | P | | P | P | P5 |
| | Neonatal Cephalic | 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 | P5,8 |
| | Musculo-skel.<br>(Superficial) | 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 | P5,8 |
| Peripheral Vessel | Other (Specify)<br>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 [phone] 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<br>(Tracks 1 & 3) | B | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other5, 8 |
|---------------------------|------------------------------------------------|---|---|------|-----|-------------------|--------------------|-----------|
| General<br>(Track I Only) | Ophthalmic | | | | | | | |
| Ophthalmic | Fetal | P | P | P | | P | P | P5 |
| | Abdominal6 | P | P | P | | P | P | P5 |
| | Intra-operative<br>(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,<br>Breast, Testes, etc.) | P | P | P | | P | P | P8 |
| | Neonatal Cephalic | 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 | P5, 8 |
| | Musculo-skel.<br>(Superficial) | 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 | 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 - :

.. | + }

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

0(k) Number (if known)

#### Device Name

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

#### Indications for Use (Describe)

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

| Clinical Application | | Mode of Operation | | | | | Other5, 8 | |
|---------------------------|------------------------------------------------|-------------------|---|------|-----|-------------------|-----------|--------------------|
| General<br>(Track 1 Only) | Specific<br>(Track 1 & 3) | B | M | PWD2 | CWD | Color<br>Doppler3 | | Combined<br>Modes4 |
| Ophthalmic | Ophthalmic | P | P | P | P | P | P | |
| Fetal Imaging &<br>Other | Fetal | P | P | P | P | P | P | P5 |
| | Abdominal | 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 |
|…