6200 Ultrasound System and 6250 Ultrasound System

K163082 · Esaote, S.p.A. · IYN · Mar 16, 2017 · Radiology

Device Facts

• Record ID: K163082
• Device Name: 6200 Ultrasound System and 6250 Ultrasound System
• Applicant: Esaote, S.p.A.
• Product Code: IYN · Radiology
• Decision Date: Mar 16, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Esaote's Model 6200 is a mainframe ultrasound system diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Intraoperative (Neurological), Laparoscopic and Other: Urologic. The 6200 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. Esaote's Model 6250 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Intraoperative (Neurological), Laparoscopic and Other: Urologic. The 6250 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. The Virtual Navigator software option for Esaote models 6200 and 6250 is intended to support a radiological clinical ultrasound examination (first modality) and follow percutaneous procedures or surgical operations providing additional image information from a second imaging modality (CT, MR, US and PET). The second modality provides additional security in assessing the morphology of the ultrasound image. Virtual Navigator can be used in the following application: Abdominal, Gynecological, Musculoskeletal, Obstetrics, Pediatric, Urologic, Small Organs, Intraoperative (Abdominal), Intraoperative (Neurological), Peripheral Vascular and Transcranial for radiological examinations only. The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information. The Virtual Navigator tracking system is contraindicated for patients, personnel and other people who use an electronic life support device (such as a cardiac pacemaker or defibrillator).

Device Story

Mainframe ultrasound systems (6200/6250) perform diagnostic imaging and fluid flow analysis; inputs include ultrasound transducer signals; system processes data via B-mode, M-mode, Doppler (PW/CW), Color Flow, and Elastosonography; outputs displayed on integrated LCD. Virtual Navigator software fuses real-time ultrasound with secondary modalities (CT, MR, PET) to assist in biopsy/needle guidance and surgical procedures. Used in clinical settings by trained professionals. Output assists clinicians in anatomical assessment and interventional guidance; benefits include improved visualization and procedural accuracy. Upgrades include MyLabRemote, expanded Elastosonography (ElaXto/QElaXto) for intraoperative/abdominal use, and AutoNT (Nuchal Translucency) measurement.

Clinical Evidence

No clinical tests were performed. Substantial equivalence is based on bench testing, including acoustic output measurement, biocompatibility, cleaning/disinfection validation, and thermal/electromagnetic/mechanical safety testing per IEC and NEMA standards.

Technological Characteristics

Mainframe ultrasound systems with LCD color display. Imaging modes: B-mode, M-mode, PW/CW Doppler, Color Flow, Tissue Velocity Mapping, 3D/4D, and Elastosonography. Connectivity: Digital storage and network capabilities. Safety standards: IEC 60601-1, IEC 60601-2-37, NEMA UD 2, NEMA UD 3. Software includes Virtual Navigator for image fusion.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in cardiac, vascular, abdominal, fetal, pediatric, small organ, musculoskeletal, and neurological applications. Includes guidance for biopsy and needle placement. Virtual Navigator indicated for radiological exams to provide secondary image fusion (CT, MR, US, PET). Contraindicated for patients/personnel with electronic life support devices (pacemakers/defibrillators).

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

• 6200 - MyLabTwice (K153277)
• 6250 - MyLabClass C (K153277)

Reference Devices

• Acuson S3000 (K130881)
• FibroScan 502 (K150239)
• Aplio 500/400/300 V6.0 (K151451)
• Arietta 70/S70/V70 (K134016)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.

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

March 16, 2017

Esaote S.p.A. % Allison Scott, RAC Managing Consultant Navigant Consulting, Inc. 9001 Wesleyan Road. Suite 200 INDIANAPOLIS IN 46268

Re: K163082

Trade/Device Name: 6200 Ultrasound System and 6250 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 13, 2017 Received: February 14, 2017

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. 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.

{1}------------------------------------------------

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'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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

K163082

Device Name

6200 Ultrasound System and 6250 Ultrasound System

# Indications for Use (Describe)

Esaote's Model 6200 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transrectal, Pediatric, Intraoperative (Abdominal), Intraoperative (Neurological), Laparoscopic and Other: Urologic.

The 6200 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Esaote's Model 6250 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transrectal, Pediatric, Intraoperative (Abdominal), Intraoperative (Neurological), Laparoscopic and Other: Urologic.

The 6250 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

The Virtual Navigator software option for Esaote models 6200 and 6250 is intended to support a radiological clinical ultrasound examination (first modality) and follow percutanes or surgical operations providing additional image information from a second imaging modality (CT, MR, US, PET and others). The second modality provides additional security in assessing the morphology of the ultrasound image. Virtual Navigator can be used in the following application: Abdominal, Gynecological, Musculos, Pediatric, Urologic, Small Organs, Intraoperative (Abdominal), Intraoperative (Neurological), Peripheral Vascular and Transcranial for radiological examinations only. The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information.

The Virtual Navigator tracking system is contraindicated for patients, operators, personnel and other people who use an electronic life support device (such as a cardiac pacemaker or defibrillator).

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)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

6200
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo

| Mode of Operations | | | | | | | | | | | |
|----------------------------------------------------------------------------------------------|--------------------|---|-----|-----|------------------|------------------------------|-----------------|---------------------------------|---------------------------|-----------------------------|------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | P | P | P | P | P | P | P | | P | P: 5, 6, 7, 11 | |
| Fetal | P | P | P | P | P | P | P | | P | P: 5, 6, 7, 8, 10, 11 N: 12 | |
| Abdominal | P | P | P | P | P | P | P | | P | P: 5, 6, 7, 8 N: 11 | |
| Intraoperative (Abdominal) | P | P | P | P | P | P | P | | P | P: 5, 6, 7 N: 8, 11 | |
| Intraoperative Neurological | P | P | P | P | P | P | P | | P | P: 5, 6, 7, 11 | |
| Pediatric | P | P | P | P | P | P | P | | P | P: 5, 6, 7, 8, 11 | |
| Small Organs [1] | P | P | P | P | P | P | P | | P | P: 5, 6, 7 | |
| Neonatal Cephalic | P | P | P | P | P | P | P | | P | P: 5, 6, 7 | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P(9) | P: 5, 6, 7 | |
| Cardiac [2] | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Transesophageal (Cardiac) | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Transesophageal (Non Cardiac) | P | P | P | P | P | P | P | | P | P: 5, 6, 7 | |
| Transrectal | P | P | P | P | P | P | P | | P | P: 5, 6, 7, 8, 11 | |
| Transvaginal | P | P | P | P | P | P | P | | P | P: 5, 6, 7, 8, 11 | |
| Transurethral | P | P | P | P | P | P | P | | P | P: 5, 6, 7, 11 | |
| Intravascular | P | P | P | P | P | P | P | | P | P: 5, 6, 7 | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | P: 5, 6, 7, 8, 11 | |
| Laparoscopic | P | P | P | P | P | P | P | | P | P: 5, 6, 7, 8, 11 | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | | P | P: 5, 6, 7, 8, 11 | |
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | | P | P: 5, 6, 7, 8, 11 | |
| Other (Urological) | P | P | P | P | P | P | P | | P | P: 5, 6, 7, 8, 11 | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | P | P | P | P | P | P | P | P | P | P | |
| Fetal | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 11 | |
| Abdominal | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 8, 10, 11 | |
| Intraoperative (Abdominal) | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 8 N: 11 | |
| Intraoperative Neurological | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 N: 8, 11 | |
| Pediatric | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 11 | |
| Small Organs [1] | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 8, 11 | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Cardiac [2] | P | P | P | P | P | P | P | P | P(9) | P: 5, 6, 7 | |
| Transesophageal (Cardiac) | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Transesophageal (Non Cardiac) | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Transrectal | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 8, 11 | |
| Transvaginal | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 8, 11 | |
| Transurethral | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 11 | |
| Intravascular | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 8, 11 | |
| Laparoscopic | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Musculo-skeletal Conventional [3] | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 8, 11 | |
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 8, 11 | |
| Other (Urological) | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 8, 11 | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | P | P | P | P | P | P | P | | | | |
| Fetal | P | P | P | | P | P | P | | | P: 5, 6, 7 | |
| Abdominal | P | P | P | | P | P | P | | | P: 5, 6, 7 | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric<br>Small Organs [1] | P | P | P | | P | P | P | | | P: 5, 6, 7 | |
| Neonatal Cephalic | P | P | P | | P | P | P | | | P: 5, 6, 7 | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | P | P | P | | P | P | P | | P | P: 5, 6, 7 | |
| Transesophageal (Cardiac)<br>Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | P: 5, 6, 7 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | | P | P: 5, 6, 7 | |
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | | P | P: 5, 6, 7 | |
| Other (Urological) | | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Fetal | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 10 | |
| Abdominal | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Small Organs [1] | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Other (Urological) | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 11 | |
| Fetal | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 10, 11 | |
| Abdominal | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 11 | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 11 | |
| Small Organs [1] | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 11 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 11 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 11 | |
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 11 | |
| Other (Urological) | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 11 | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | P | P | P | | P | P | P | | | | |
| Fetal | P | P | P | | P | P | P | | P | P: 5, 6, 7, 11 | |
| Abdominal | P | P | P | | P | P | P | | P | P: 5, 6, 7, 8, 10, 11 | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | P: 5, 6, 7, 11 | |
| Small Organs [1] | P | P | P | | P | P | P | | P | P: 5, 6, 7, 11 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | P | P | P | | P | P | P | | P | P: 5, 6, 7 | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | P: 5, 6, 7, 11 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | | P | P: 5, 6, 7, 11 | |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | P: 5, 6, 7, 11 | |
| Other (Urological) | P | P | P | | P | P | P | | P | P: 5, 6, 7 | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(PD) | Combined<br>[4] | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | |
| Ophthalmic | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 11 | |
| Fetal | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 10, 11 | |
| Abdominal | P | P | P | P | P | P | P | P | P | | |
| Intraoperative (Abdominal) | | | | | | | P | | | | |
| Intraoperative Neurological | | | | | | | P | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 11 | |
| Small Organs [1] | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 11 | |
| Neonatal Cephalic | | | | | | | P | | | | |
| Adult Cephalic | | | | | | | P | | | | |
| Cardiac [2] | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Transesophageal (Cardiac) | | | | | | | P | | | | |
| Transesophageal (Non Cardiac) | | | | | | | P | | | | |
| Transrectal | | | | | | | P | | | | |
| Transvaginal | | | | | | | P | | | | |
| Transurethral | | | | | | | P | | | | |
| Intravascular | | | | | | | P | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 11 | |
| Laparoscopic | | | | | | | P | | | | |
| Musculo-skeletal Conventional [1] | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 11 | |
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 11 | |
| Other (Urological) | P | P | P | P | P | P | P | P | P | P: 5, 6, 7, 11 | |
| Mode of Operations | | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Color 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 | P: 5, 6, 7, 11 | |
| Abdominal | P | P | P | P | P | P | P | | P | P: 5, 6, 7, 10, 11 | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | P | P | P | P | P | P | P | | P | P: 5, 6, 7 N: 11 | |
| Pediatric | P | P | P | P | P | P | P | | P | P: 5, 6, 7, 11 | |
| Small Organs [1] | P | P | P | P | P | P | P | | P | P: 5, 6, 7, 11 | |
| Neonatal Cephalic | P | P | P | P | P | P | P | | P | P: 5, 6, 7 | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | P | P | P | P | P | P | P | | P (9) | P: 5, 6, 7 | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | P: 5, 6, 7, 11 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | | P | P: 5, 6, 7, 11 | |
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | | P | P: 5, 6, 7, 11 | |
| Other (Urological) | | | | | | | | | | | |
| New indication; P: Previously cleared by FDA; E:Added under Appendix E | | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | P | P | P | | P | P | P | | | P: 5, 6, 7, 11 | |
| Fetal | P | P | P | | P | P | P | | P | P: 5, 6, 7, 11 E: 8 | |
| Abdominal | P | P | P | | P | P | P | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | P: 5, 6, 7, 11 | |
| Small Organs [1] | P | P | P | | P | P | P | | P | P: 5, 6, 7, 11 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | P | P | P | | P | P | P | | P | P: 5, 6, 7 | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | P: 5, 6, 7, 11 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | | P | P: 5, 6, 7, 11 | |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | P: 5, 6, 7, 11 | |
| Other (Urological) | P | P | P | | P | P | P | | P | P: 5, 6, 7, 11 | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Fetal | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Abdominal | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Small Organs [1] | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Other (Urological) | P | P | P | P | P | P | P | P | P | P: 5, 6, 7 | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | P | P | P | | P | P | P | | | | |
| Fetal | P | P | P | | P | P | P | | P | P: 5, 6, 7, 11 | |
| Abdominal | P | P | P | | P | P | P | | P | P: 5, 6, 7, 8, 10, 11 | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | P | P | P | | P | P | P | | P | P: 5, 6, 7 N: 8, 11 | |
| Pediatric | P | P | P | | P | P | P | | P | P: 5, 6, 7, 11 | |
| Small Organs [1] | P | P | P | | P | P | P | | P | P: 5, 6, 7, 8, 11 | |
| Neonatal Cephalic | P | P | P | | P | P | P | | P | P: 5, 6, 7 | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | P | P | P | | P | P | P | | P | P: 5, 6, 7 | |
| Transesophageal (Cardiac) | | | | | | | | |…