7400 Ultrasound Systems

K190447 · Navigant Consulting - on Behalf of Esaote S.P.A. · IYN · Apr 1, 2019 · Radiology

Device Facts

• Record ID: K190447
• Device Name: 7400 Ultrasound Systems
• Applicant: Navigant Consulting - on Behalf of Esaote S.P.A.
• Product Code: IYN · Radiology
• Decision Date: Apr 1, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Esaote 7400, MyLabOmega, is a compact portable system intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel. The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular, or other anatomical structures, as well as peripheral nerve blocks in Musculoskeletal applications. The ultrasonic medical diagnostic equipment is intended to be connected to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes.

Device Story

The 7400 Ultrasound System (MyLabOmega) is a portable, handle-equipped diagnostic ultrasound device. It processes inputs from various mechanical and electronic probes (convex, linear, phased, Doppler, volumetric) to generate real-time images on an integrated LCD color display. The system supports multiple imaging modes: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D, and 4D. It features a touchscreen with an emulated QWERTY keyboard for data entry and wireless connectivity. Used in clinical settings by healthcare professionals, the device assists in diagnostic studies, biopsy guidance, and needle/catheter placement. The system runs on Windows 10 Enterprise LTSB and includes advanced options like Auto NT, MicroV, Qpack, and 4D Stic. The output allows clinicians to visualize anatomical structures and blood flow, facilitating clinical decision-making and procedural guidance.

Clinical Evidence

No clinical tests were performed. Substantial equivalence is supported by bench testing, including acoustic output measurements (NEMA UD-2, NEMA UD-3), electrical/mechanical safety (IEC 60601-1, IEC 60601-2-37), and electromagnetic compatibility (IEC 60601-1-2).

Technological Characteristics

Portable ultrasound system with LCD display, touchscreen, and wireless capability. Operates on Windows 10 Enterprise LTSB. Supports phased, convex, linear, Doppler, and volumetric probes. Imaging modes: B, M, TEI, MView, Doppler, CFM, AD, TVM, 3D, 4D. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD-2, NEMA UD-3.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal, abdominal, intraoperative, laparoscopic, pediatric, small organ, neonatal, cephalic, transvaginal, musculoskeletal, urological, cardiovascular, and peripheral vessel applications. Includes guidance for biopsy, needle/catheter placement, and peripheral nerve blocks.

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

• 7400 - MyLabAlpha (K161359)

Reference Devices

• 6440 - MyLab 9 eXP (K173291)

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue.

April 1, 2019

Esaote S.p.A. % Allison Scott, RAC Associate Director Navigant Consulting, Inc. 9100 Keystone Crossing, Suite 500 INDIANAPOLIS IN 46240

Re: K190447

Trade/Device Name: 7400 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: March 4, 2019 Received: March 5, 2019

Dear Ms. Scott:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Sincerely,

Michael D. D'Hara

Thalia Mills, 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)

### K190447

Device Name 7400 Ultrasound System

### Indications for Use (Describe)

Esaote 7400, MyLabOmega, is a compact portable system intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel.

The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular, or other anatomical structures, as well as peripheral nerve blocks in Musculoskeletal applications.

The ultrasonic medical diagnostic equipment is intended to be connected to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | | | | | |
|----------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|------------------------------|-----------------|----------------------------------|---------------------------|-----------------|
| | | | | | | Mode of Operations | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(PD) | Combined<br>[4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | P | P | P | P | P | P | P | | P | P: 5, 6 |
| Fetal | P | P | P | P | P | P | P | | P | P: 5, 6 |
| Abdominal | P | P | P | P | P | P | P | | P | P: 5 |
| Intraoperative (Abdominal) | P | P | P | P | P | P | P | | P | P: 5 |
| Intraoperative Neurological | P | P | P | P | P | P | P | | P | P: 5 |
| Pediatric | P | P | P | P | P | P | P | | P | P: 5 |
| Small Organs [1] | P | P | P | P | P | P | P | | P | P (7) |
| Neonatal Cephalic | P | P | P | P | P | P | P | | P | P: 5 |
| Adult Cephalic | P | P | P | P | P | P | P | | P | P: 5 |
| Cardiac [2] | P | P | P | P | P | P | P | P | P | P: 5 |
| Transesophageal (Cardiac) [2] | P | P | P | P | P | P | P | P | P | P: 5 |
| Transesophageal (Non Cardiac) | P | P | P | P | P | P | P | P | P | P: 5, 6 |
| Transrectal | P | P | P | P | P | P | P | | P | P: 5, 6 |
| Transvaginal | P | P | P | P | P | P | P | | P | P: 5 |
| Transurethral | P | P | P | P | P | P | P | | P | P: 5 |
| Intravascular | P | P | P | P | P | P | P | | P | P: 5 |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | P: 5 |
| Laparoscopic | P | P | P | P | P | P | P | | P | P: 5 |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | | P | P: 5 |
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | | P | P: 5 |
| Other (Urological) | P | P | P | P | P | P | P | | P | P: 5 P: 6 |

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| SP2442<br>Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Tissue Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | | | | | | | | |
|--------------------------------------------------------------------------------------------------------|----------------------|---|-----|-----|------------------|------------------------------|------------------------|-------------------|-----------------------------------|------------------------|-----------------|---|--|---|---|---|--|---|------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(PD) | Combined<br>[4] | Tissue<br>Mapping | Ophthalmic | | | | | | | | | | |
| Ophthalmic | | | | | | | | | Fetal | | | | | | | | | | |
| Fetal | | | | | | | | | Abdominal | P | P | P | | P | P | P | | P | P: 5 |
| Abdominal | | | | | | | | | Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | Intraoperative Neurological | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | Pediatric | P | P | P | | P | P | P | | P | P: 5 |
| Pediatric | | | P | P | P | P | P | | Small Organs [1] | P | P | P | | P | P | P | | P | P: 5 |
| Small Organs [1] | | | | | | | | | Neonatal Cephalic | | | | | | | | | | |
| Neonatal Cephalic | | | P | P | P | P | P | | Adult Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | Cardiac [2] | P | P | P | | P | P | P | | P | P: 5 |
| Cardiac [2] | | | P | P | P | P | P | | Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | Transrectal | | | | | | | | | | |
| Transrectal | | | | | | | | | Transvaginal | | | | | | | | | | |
| Transvaginal | | | | | | | | | Transurethral | | | | | | | | | | |
| Transurethral | | | | | | | | | Intravascular | | | | | | | | | | |
| Intravascular | | | | | | | | | Peripheral Vascular | P | P | P | | P | P | P | | P | P: 5 |
| Peripheral Vascular | | | P | P | P | P | P | | Laparoscopic | | | | | | | | | | |
| Laparoscopic | | | | | | | | | Musculo-skeletal Conventional [3] | P | P | P | | P | P | P | | P | P: 5 |
| Musculo-skeletal Conventional | | | | | | | | | Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | P: 5 |
| Other (Urological) | | | | | | | | | | | | | | | | | | | |

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| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Tissue Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
|--------------------------------------------------------------------------------------------------------------------|--------------------|---|-----|-----|------------------|------------------------------|------------------------|----------------------------------|-------------------------------|---------------------------|-----------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | E | E | E | | E | E | E | | E | E: 5 | |
| Small Organs [1] | E | E | E | | E | E | E | | E | E: 5 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | E | E | E | | E | E | E | | E | E: 5 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | E | E | E | | E | E | E | | E | E: 5 | |
| Musculo-skeletal Superficial [3] | E | E | E | | E | E | E | | E | E: 5 | |
| Other (Urological) | | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(PD) | Combined<br>[4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | |
| Ophthalmic | P | P | P | | P | P | P | | | | |
| Fetal | P | P | P | | P | P | P | | | P: 5 | |
| Abdominal | P | P | P | | P | P | P | | P | P: 5 | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | P: 5 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | | P | P: 5 | |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | P: 5 | |
| Other (Urological) | P | P | P | | P | P | P | | P | P: 5 | |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(PD) | Combined<br>[4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | | P | P: 5 | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | P: 5 | |
| Small Organs [1] | P | P | P | | P | P | P | | P | P: 5 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | P | P | P | | P | P | P | | P | P: 5 | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | P: 5 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | | |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | | | | | | |
| Clinical Application | Mode of Operations | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Tissue Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) |
| Ophthalmic | | P | P | P | P | P | P | P | | | |
| Fetal | | P | P | P | P | P | P | P | | | P: 5 |
| Abdominal | | P | P | P | P | P | P | P | | | P: 5 |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | P | | | P: 5 |
| Small Organs [1] | | P | P | P | P | P | P | P | | | P: 5 |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | P | P | P | P | | | P: 5 |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | | P | P | P | P | P | P | P | | | P: 5 |
| Musculo-skeletal Superficial [3] | | P | P | P | P | P | P | P | | | P: 5 |
| Other (Urological) | | P | P | P | P | P | P | P | | | P: 5 |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:<br>Mode of Operations | | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Tissue Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | P | P | P | | | | | | | | |
| Fetal | | | P | | P | P | P | | P | P: 5 | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | P | P | | P | P | P | | P | P: 5 | |
| Transvaginal | | P | P | | P | P | P | | P | P: 5 | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | | |
| Other (Urological) | | P | P | | P | P | P | | P | P: 5 | |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | | | | | | |
| Clinical Application | Mode of Operations | | | | | | | | Other (specify) | | |
| | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(PD) | Combined<br>[4] | Tissue Velocity<br>Mapping (TVM) | | Harmonic<br>Imaging (TEI) | |
| Ophthalmic | E | E | E | | E | E | E | | E | E: 5 | |
| Fetal | E | E | E | | E | E | E | | E | E: 5 | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | E | E | E | | E | E | E | | E | E: 5 | |
| Transvaginal | E | E | E | | E | E | E | | E | E: 5 | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | | |
| Other (Urological) | E | E | E | | E | E | E | | E | E: 5 | |
| | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(PD) | Combined<br>[4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | |
| Clinical Application | Mode of Operations | | | | | | | | | | |
| Ophthalmic | P | P | P | | P | P | P | | | | |
| Fetal | P | P | P | | P | P | P | | | | |
| Abdominal | P | P | P | | P | P | P | | P | P: 5 | |
| Intraoperative (Abdominal) | P | P | P | | P | P | P | | P | P: 5 | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | P: 5 | |
| Small Organs [1] | P | P | P | | P | P | P | | P | P: 5 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | P: 5 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | | P | P: 5…