ZS3 Ultrasound System, z.one pro Ultrasound System

K171891 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Sep 21, 2017 · Radiology

Device Facts

• Record ID: K171891
• Device Name: ZS3 Ultrasound System, z.one pro Ultrasound System
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Sep 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ZS3 and z.one pro Ultrasound Systems are intended for use by a qualified physician for ultrasound evaluation of Opthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic(cardiac), and vascular); Intraoperative(Neuro); Pediatric; Small organ (thyroid, breast, testes, etc); Neonatal cephalic; Adult 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 full-featured, software-controlled 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 support multiple imaging modes (B-mode, M-mode, PWD, CWD, Color Doppler, 3D/4D, CEUS, ARFI) and connect up to three transducers. Operated by qualified physicians in clinical settings, the systems provide real-time visualization of anatomic structures and fluid flow. Users interact via a soft-menu control interface to adjust settings based on exam-specific defaults or personal preference. The output assists clinicians in diagnostic evaluation and clinical decision-making across various medical specialties, potentially benefiting patients through non-invasive, high-resolution imaging.

Clinical Evidence

No clinical data. The device was evaluated via bench testing only, including acoustic output measurements, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety testing in compliance with recognized standards (e.g., IEC 60601-1, IEC 60601-2-37, ISO 10993-1).

Technological Characteristics

General-purpose diagnostic ultrasound system using zone technology. Features include B-mode, M-mode, PWD, CWD, Color Doppler, 3D/4D, CEUS, and ARFI. Connectivity supports multi-transducer ports. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and NEMA UD 2/UD 3. Patient-contact materials tested per ISO 10993-1. Software developed per IEC 62304.

Indications for Use

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

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 (K151175)
• DC-8 (K170277)
• Voluson S8 (K160184)
• Logiq E9 (K163077)
• M9 (K152543)

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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, stacked on top of each other.

September 21, 2017

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

Shenzhen Mindray Bio-Medical Electronics Co., Ltd % Mr. Zhai Pei Engineer of Technical Regulation Department Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen 518057, Guangdong CHINA

Re: K171891

Trade/Device Name: ZS3 and z.one Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: August 15, 2017 Received: August 21, 2017

Dear Mr. Pei:

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.

Michael D. O'Hara For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

#### K171891

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 Opthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic(cardiac), and vascular); Intraoperative (Neuro); Pediatric; Small organ (thyroid, breast, testes, etc); Neonatal cephalic/Transcrania; Trans-rectal; Trans-vaginal; Trans-esoph.(non-Card); Musculoskeletal(Conventional); Musculoskeletal(Superticial); Cardiac Adult; Cardiac Pediatric; Trans-esoph. (Cardiac); Intra-cardiac; Peripheral vessel.

Type of Use (Select one or both, as applicable)

V Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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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<br>1 Only) | Specific(Track 1 & 3) | B | M | PWD<br>2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other | |
| Ophthalmic | Ophthalmic | P | | P | | P | P | | |
| Fetal Imaging<br>& Other | Fetal | P | P | P | P | P | P | P5, P9 | |
| | Abdominal6 | P | P | P | P | P | P | P5, P9, N11, N12 | |
| | Intra-operative (Specify)7 | P | P | P | | P | P | P5 | |
| | Intra-operative (Neuro) | P | P | P | | P | P | P5 | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | P | | P | P5, P9 | |
| | Small Organ (Thyroid, Breast,<br>Testes, etc.) | P | P | P | | P | P | P5, P8 | |
| | Neonatal Cephalic | P | P | P | P | P | P | P5 | |
| & Other | Adult Cephalic/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 (Conventional) | P | P | P | | P | P | P5, P8 | |
| | Musculo-skeletal (Superficial) | P | P | P | | | P | P5, P8 | |
| | Intravascular | | | | | | | | |
| Cardiac | Cardiac Adult | P1 | P | P | P | P | P | P5, P10 | |
| | Cardiac Pediatric | P | P | P | P | P | P | P5, N10 | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | P | P | P | P | P | P | P5, N10 | |
| | Intra-cardiac | P | P | P | P | P | P | N10 | |
| | Other(Specify) | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | P | P | P | P5, P8, P9 | |
| | 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 | | | | | | | | | |
| | | | | | | Mode of Operation | | | |
| 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 | | | | | | | | | |
| General(Track<br>1 Only) | Specific(Track 1 & 3) | B | M | PWD<br>2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | P | P | P | | |
| | Abdominal6 | P | P | P | P | P | P | N11, N12 | |
| | Intra-operative (Specify)7 | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | | |
| | Small Organ (Thyroid, Breast,<br>Testes, etc.) | | | | | | | | |
| Fetal Imaging<br>& Other | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal (Conventional) | P | P | P | | P | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | P1 | P | P | P | P | P | P10 | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| Cardiac | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other(Specify) | | | | | | | | |
| Peripheral<br>vessel | 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 | | | | | | | | | |
| | | | | | | Mode of Operation | | | |
| 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 | | | | | | | | | |
| General(Track<br>1 Only) | Specific(Track 1 & 3) | B | M | PWD<br>2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | P5 | |
| | Abdominal6 | P | P | P | | P | P | P5, N11 | |
| | Intra-operative (Specify)7 | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | P | P | P | | P | P | P5 | |
| | Small Organ (Thyroid, Breast,<br>Testes, etc.) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| Cardiac | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other(Specify) | | | | | | | | |
| | 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 | | | | | | | | | |
| | | B | M | PWD<br>2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other | |
| 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<br>1 Only) | Specific(Track 1 & 3) | B | M | PWD<br>2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | p5 | |
| | Abdominal6 | P | P | P | | P | P | P5, N11 | |
| | Intra-operative (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, Breast,<br>Testes, etc.) | | | | | | | | |
| Fetal Imaging<br>& Other | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal (Conventional) | P | P | P | | P | P | p5 | |
| | Musculo-skeletal (Superficial) | P | P | P | | P | P | p5 | |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other(Specify) | | | | | | | | |
| Peripheral<br>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 | | | | | | | | | |
| | | | | | | | | | |
| 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<br>1 Only) | Specific(Track 1 & 3) | B | M | PWD<br>2 | CWD | Color<br>Doppler3 | Combined<br>Modes4 | Other | |
| Ophthalmic | Ophthalmic | P | P | P | CWD | P | P | | |
| | Fetal | P | P | P | P | P | P | p5 | |
| | Abdominal6 | P | P | P | P | P | P | P5, N11 | |
| | 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 | |
| Fetal Imaging | Small Organ (Thyroid, Breast,<br>Testes, etc.) | | | | | | | | |
| & Other | Neonatal Cephalic | P | P | P | P | P | P | p5 | |
| | Adult Cephalic/Transcranial | P | P | P | P | P | P | p5 | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | P5, N10 | |
| | Cardiac Pediatric | P | P | P | P | P | P | P5, N10 | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other(Specify) | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | P | P | P | p5 | |
| 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, 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 | | | | | | | | | |
|…