ZS3 and z.one pro Ultrasound Systems

K192410 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Dec 19, 2019 · Radiology

Device Facts

• Record ID: K192410
• Device Name: ZS3 and z.one pro Ultrasound Systems
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Dec 19, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic(cardiac); Intraoperative (Neuro); Laparoscopic; Pediatic; Small organ (thyroid, breast, testes, etc); Neonatal cephalic/ Transcranial; Trans-rectal; Trans-vaginal; Trans-esoph.(non-Card); Musculoskeletal (Conventional); Musculoskeletal (Superficial);Cardiac Adult; Cardiac Pediatric; Trans-esoph. (Cardiac); Intra-cardiac; Peripheral vessel.

Device Story

The ZS3 and z.one pro are software-controlled, general-purpose diagnostic ultrasound systems. They acquire and display high-resolution, real-time ultrasound data using zone technology to collect more data simultaneously for optimized image quality. The systems are operated by qualified physicians in clinical settings. They support multiple imaging modes (B-mode, M-mode, PWD, CWD, Color Doppler, and combined modes) and connect up to three transducers. The system processes received ultrasonic echoes to generate anatomical and fluid flow displays. It includes advanced features like 2D SWI, CEUS, and needle visualization. The output is viewed by clinicians to perform measurements and calculations, aiding in diagnostic decision-making and patient evaluation.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including acoustic output measurements, biocompatibility testing (ISO 10993-1), and compliance with electrical/mechanical safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304).

Technological Characteristics

Ultrasound imaging system using zone technology. Materials: RTV 162 (mucilage glue) in transducers. Connectivity: Wireless Ethernet routers/bridges. Software: IEC 62304 compliant. Safety: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37. Power: Battery or AC. Transducers: C4-1, C6-2, P4-1c, C9-3, C10-3, L8-3, L14-5w, L10-5, L14-5sp, L30-8, P7-3c, C12-4lp, E9-3, E9-4, E9-3 3D, C8-3 3D, P4-1c, P9-3ic, A2CW, A5CW, C9-3sp, C6-1, C18-5, P8-3mTEE.

Indications for Use

Indicated for ultrasound evaluation of ophthalmic, fetal, abdominal (renal, GYN/pelvic), intra-operative (abdominal, thoracic/cardiac, vascular), neuro-intraoperative, laparoscopic, pediatric, small organ (thyroid, breast, testes), neonatal cephalic, transcranial, trans-rectal, trans-vaginal, trans-esophageal (non-cardiac/cardiac), musculoskeletal (conventional/superficial), adult/pediatric cardiac, intra-cardiac, and peripheral vessel 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

• ZS3, z.one pro (K171891)

Reference Devices

• Noblus (K160559)
• Resona 7 (K171233)
• Logiq P9 (K181783)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 19, 2019

ShenZhen Mindray Bio-Medical Electronics Co., Ltd. % Jiang Haosen Engineer of Technical Regulation Keji 12th Road South, High-tech Industrial Park, Shenzhen, Guangdong 518057 CHINA

#### Re: K192410

Trade/Device Name: ZS3 and z.one pro Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: November 15, 2019 Received: November 18, 2019

#### Dear Jiang Haosen:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K192410

Device Name

ZS3 and z.one pro Ultrasound 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; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic(cardiac); Intraoperative (Neuro); Laparoscopic; Pediatic; Small organ (thyroid, breast, testes, etc); Neonatal cephalic/ Transcranial; Trans-rectal; Trans-vaginal; Trans-esoph.(non-Card); Musculoskeletal (Conventional); Musculoskeletal (Superficial);Cardiac Adult; Cardiac Pediatric; Trans-esoph. (Cardiac); Intra-cardiac; Peripheral vessel.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| <div> <span style="font-size: 16px;">✔</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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| System: | ZS3, z.one pro Ultrasound System | | | | | | | | |
|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----|---|------|-----|-------------------|--------------------|-----------------------|--|
| Transducer: | System union of all transducer types | | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | | |
| General(Track 1<br>Only) | Specific(Track 1 & 3) | B | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other | |
| Ophthalmic | Ophthalmic | P | | P | | P | P | | |
| | Fetal | P | P | P | P | P | P | P5, P9 | |
| | Abdominal6 | P | P | P | P | P | P | P5, P9, P11, P12, N13 | |
| | Intra-operative (Specify)7 | P | P | P | | P | P | P5 | |
| | Intra-operative (Neuro) | P | P | P | | P | P | P5 | |
| | Laparoscopic | N | N | N | | N | N | N5, N11 | |
| | Pediatric | P | P | P | P | P | P | P5, P9 | |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.) | P | P | P | | P | P | P5, p8 | |
| Fetal Imaging &<br>Other | Neonatal Cephalic | P | P | P | P | P | P | P5 | |
| | Adult Cephalic/<br>Transcranial | P | P | P | P | P | P | P5 | |
| | Trans-rectal | P | P | P | | P | P | P5, P9 | |
| | Trans-vaginal | P | P | P | | P | P | P5, P9 | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | P | P | P | P | P | P | P5 | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | | P | P | P5, p8 | |
| | Musculo-skeletal<br>(Superficial) | P | P | P | | P | P | P5, p8 | |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | P1 | P | P | P | P | P | P5, P10 | |
| | Cardiac Pediatric | P | P | P | P | P | P | p5 p10 | |
| | | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | P | P | P | P | P | P | P5, p10 | |
| | Intra-cardiac | P | P | P | P | P | P | P10, N5 | |
| | Other(Specify) | | | | | | | | |
| | Peripheral vessel | P | P | P | P | P | P | P5, P8, P9 | |
| Peripheral vessel | Other(Specify) | | | | | | | | |
| | N=new system indication; P=previously cleared by FDA; | | | | | | | | |
| | 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 ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | | | | | | | | | |
| 8 Freehand tissue elasticity | | | | | | | | | |
| 9 3D/4D | | | | | | | | | |
| 10 CEUS (Contrast agent for LVO) | | | | | | | | | |
| 11 CEUS (Contrast agent for Liver) | | | | | | | | | |
| 12 ARFI | | | | | | | | | |
| 13 2D SWI | | | | | | | | | |
| System: | ZS3, z.one pro Ultrasound System | | | | | | | | |
| Transducer: | Curvillinear Transducer C4-1 | | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | | |
| General(Track 1<br>Only) | Specific(Track 1 & 3) | B | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | P | P | P | N5 | |
| | Abdominal6 | P | P | P | P | P | P | P11, P12, N5,N13 | |
| | Intra-operative (Specify)7 | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | N5 | |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| Fetal Imaging &<br>Other | Adult Cephalic/<br>Transcranial | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | | P | | N5 | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | P1 | P | P | P | P | P | P10, N5 | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other(Specify) | | | | | | | | |
| Peripheral vessel | Peripheral vessel | N | N | N | N | N | N | N5 | |
| | Other(Specify) | | | | | | | | |
| | N=new system indication; P=previously cleared by FDA; | | | | | | | | |
| | 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 ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | | | | | | | | | |
| 8 Freehand tissue elasticity | | | | | | | | | |
| 9 3D/4D | | | | | | | | | |
| 10 CEUS (Contrast agent for LVO) | | | | | | | | | |
| 11 CEUS (Contrast agent for Liver) | | | | | | | | | |
| 12 ARFI | | | | | | | | | |
| 13 2D SWI | | | | | | | | | |

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| System: | ZS3, z.one pro Ultrasound System | | | | | | | |
|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|---|---|------|-----|-------------------|--------------------|---------|
| Transducer: | Curvillinear Transducer C6-2 | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | |
| General(Track 1<br>Only) | Specific(Track 1 & 3) | B | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | p5 |
| | Abdominal6 | P | P | P | | P | P | p5, p11 |
| | Intra-operative (Specify)7 | | | | | | | |
| | 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/<br>Transcranial | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other(Specify) | | | | | | | |
| Peripheral vessel | Peripheral vessel | P | P | P | | P | P | p5 |
| | Other (Specify) | | | | | | | |
| | N=new system indication; P=previously cleared by FDA; | | | | | | | |
| | 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 ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | | | | | | | | |
| 8 Freehand tissue elasticity | | | | | | | | |
| 9 3D/4D | | | | | | | | |
| 10 CEUS (Contrast agent for LVO) | | | | | | | | |
| 11 CEUS (Contrast agent for Liver) | | | | | | | | |
| 12 ARFI | | | | | | | | |
| 13 2D SWI | | | | | | | | |

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| System: | ZS3, z.one pro Ultrasound System | | | | | | | | |
|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----------------------|---|------|------|-------------------|--------------------|--------------------|---------|
| Transducer: | Curvillinear Transducer C9-3 | | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | | |
| General (Track 1<br>Only) | Specific(Track 1 & 3) | B | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | p5 | |
| | Abdominal6 | P | P | P | | P | P | p5, p11 | |
| | Intra-operative<br>(Specify)7.1, 7.3 | P | P | P | | P | P | p5 | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | p5 | |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.) | N | N | N | | N | N | N5 | |
| Fetal Imaging &<br>Other | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic/<br>Transcranial | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | | P | P | p5 | |
| | Musculo-skeletal<br>(Superficial) | P | P | P | | P | P | p5 | |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| Cardiac | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other(Specify) | | | | | | | | |
| | Peripheral vessel | P | P | P | | P | P | p5 | |
| | Peripheral vessel | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| | N=new system indication; P=previously cleared by FDA; | | | | | | | | |
| | 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 ( 7.1 abdominal, 7.2 thoracic (Cardiac) and 7.3 vascular (PV) ) | | | | | | | | | |
| 8 Freehand tissue elasticity | | | | | | | | | |
| 9 3D/4D | | | | | | | | | |
| 10 CEUS (Contrast agent for LVO) | | | | | | | | | |
| 11 CEUS (Contrast agent for Liver) | | | | | | | | | |
| 12 ARFI | | | | | | | | | |
| System: | ZS3, z.one pro Ultrasound System | | | | | | | | |
| Transducer: | Convex Transducer C10-3 | | | | | | | | |
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
| Clinical Application | | | | | | Mode of Operation | | | |
| General(Track 1<br>Only) | Specific(Track 1 & 3) | B | M | PWD2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other | |
| Ophthalmic | Ophthalmic | P | | P | | P | P | | |
| | Fetal | P | P | P | P | P | P | p5 | |
| | Abdominal6 | P | P | P | P | P | P | p5, p11 | |
| | Intra-operative (Specify)7 | P | P | P | P | P | P | p5 | |
| | Intra-operative (Neuro) | P | P | P | P | P | P | p5 | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | P | P | P | p5 | |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.) | | | | | | | | |
| Fetal Imaging &<br>Other | Neonatal Cephalic | P | P | P | P | P | P | p5 | |
| | Adult Cephalic/<br>Transcranial | P | P | P | P | P | P | p5 | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | p5, p10 | |
| | Cardiac Pediatric | P | P | P | P | P | P | p5, p10 | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other(Specify) | | | | | | | | |
| Peripheral vessel | Peripheral vessel | P | P | P | P | P | P | p5 | |
| | Other(Specify) | | | | | | | | |
| System: | ZS3, z.one pro Ultrasound System | | | | | | | | |
| Transducer: | Curvillinear Transducer C8-3 3D | | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | |
| Clinical Application | | | | | | Mode of Operation | | | |
| General(Track 1 | | | | | | Color | Combined | | |
| Only) | Specific(Track 1 & 3) | B | M | PWD2 | CWD | Doppler3 | Modes4 | Other | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | P5, P9 | |
| | Abdominal6 | P | P | P | | P | P | P5, P9, P11 | |
| | Intra-operative (Specify)7 | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P5, P9 | |
| | Small Organ (Thyroid, | | | | | | | | |
| | Breast, Testes, etc.) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| Fetal Imaging & | Adult Cephalic/ | | | | | | | | |
| Other | Transcranial | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral…