MYLABTWICE, MODEL 6200
Device Facts
| Record ID | K100931 |
|---|---|
| Device Name | MYLABTWICE, MODEL 6200 |
| Applicant | Esaote, S.p.A. |
| Product Code | IYN · Radiology |
| Decision Date | Jun 25, 2010 |
| 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 used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), 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. The Virtual Navigator is a MyLab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasound session. The second modality provides additional security in assessing the morphology of the ultrasound image. Virtual Navigator can be used in the following application: Abdominal, Musculo-skeletal, Urologic, and Vascular. 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 should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.
Device Story
6200 System is a mainframe ultrasound imaging system for diagnostic general ultrasound studies. It processes ultrasonic pulse echo and Doppler signals to generate B-Mode, M-Mode, Color Flow, and Tissue Velocity images. The system features a touch screen control panel, LCD display, and supports various linear, convex, and phased array probes. It is operated by clinicians in clinical settings. The Virtual Navigator optional license enables fusion imaging by overlaying data from a second modality (CT or MR) onto the real-time ultrasound image to assist in anatomical assessment and biopsy guidance. The system provides visual output to the clinician to aid in diagnosis, needle placement, and peripheral nerve blocks. It benefits patients by providing enhanced anatomical visualization and guidance for interventional procedures.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Mainframe ultrasound system; supports B-Mode, M-Mode, Doppler, Color Flow, Tissue Velocity Mapping, and Tissue Enhancement Imaging. Connectivity via standard probe ports. Manufactured under ISO 9001:2000 and ISO 13485. Software/firmware-controlled interface with touch screen input. Virtual Navigator license for multi-modality image fusion.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis in patients requiring Cardiac, Transesophageal, Peripheral Vascular, Neonatal/Adult Cephalic, Small organ, Musculoskeletal, Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative, Laparoscopic, and Urologic studies. Contraindicated for use of Virtual Navigator tracking system on/around patients with cardiac pacemakers or life-supporting equipment.
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
Related Devices
- K103152 — 6250 ULTRASOUND SYTEMS · Esaote, S.p.A. · Jan 7, 2011
- K153277 — 6200 Ultrasound System and 6250 Ultrasound System · Esaote, S.p.A. · May 4, 2016
- K133905 — 6200 / 6250 ULTRASOUND SYSTEM · Esaote, S.p.A. · Apr 15, 2014
- K163082 — 6200 Ultrasound System and 6250 Ultrasound System · Esaote, S.p.A. · Mar 16, 2017
- K173291 — 6440 Ultrasound System · Esaote, S.p.A. · Jan 12, 2018
Submission Summary (Full Text)
{0}------------------------------------------------
(10093)
Esaote, S.p.A.
# JUN 2 5 2010
# Special 510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR1807.92(a).
807.92(a)(1)
# Submitter Information
Esaote S.p.,A Via Siffredi 58 16153 Genova Italy
Contact Person:
Allison Scott 317.569.9500 x106 ascott@ansongroup.com
Date:
April 2, 2010
807.92(a)(2)
Trade Name:
6200 System
Common Name: Ultrasound Imaging System
Ultrasonic pulse Doppler imaging system 892.1550 Classification Name(s):
Ultrasonic pulsed echo imaging system 892.1560
90IYN; 90IYO Classification Number:
## 807.92(a)(3)
# Predicate Device(s)
K051837, K060827, K081386
6100
Esaote, S.p.A.
{1}------------------------------------------------
Special 510(k) Summary 6200 System Esaole. S.p.A.
## 807.92 (a)(4)
# Device Description
The 6100 is a mainframe ultrasound system, used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The system is equipped with a LCD Color Display, a control panel and is capable of operating Linear, Convex, and Phased array probes.
The 6100 system has been cleared by FDA via K051837, K060827 and K081386.
The modified 6100, with respect to the cleared version 6100 via K051837, K060827 and K081386, is due to the improvements of the system. These modifications, that do not affect the intended use or alter the fundamental scientific technology of the device, are the following:
- a. New keyboard (control panel), where some control keys (knobs and keys) have been replaced by a touch screen.
- b. New plastic housing of the system both to include the touch screen and to give a new style
- c. New keyboard group PCBs lay out to interface the touch screen and to match the new organization of the panel keys.
- d. Software/Firmware modification to translate the touch screen information for the software: main software characteristics and performances have not been changed.
The 6200 is the model name of the modified 6100. The set of probes of the 6100 is exactly the same.
The 6200 system is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.
# 807.92(a)(5)
# Intended Use(s)
Esaote's Model 6200 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), 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.
{2}------------------------------------------------
Special 510ck) Summar 6 200 St stept I-saote. S.p. V
The Virtual Navigator is a MyLab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasound session. The second modality provides additional security in assessing the morphology of the ultrasound image.
Virtual Navigator can be used in the following application: Abdominal, Musculo-skeletal, Urologic, and Vascular.
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 should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.
## 807.92(a)(6)
# Technological Characteristics
The modifications reflected in this Special 510(k) for the 6200 are intended to improve the system's performance. The modifications have not altered the fundamental scientific technology or the intended use of the unmodified version of the 6100 cleared via K051837, K060827 and K081386.
{3}------------------------------------------------
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
' JUN 25 2010
EASOTE, S.P.A. % Ms. Allison Scott, RAC Regulatory Affairs Associate The Anson Group 11460 Meridian St., Ste 150 CARMEL IN 46032
Re: K100931
Trade/Device Name: 6200 Ultrasound Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: May 28, 2010 Received: June 1, 2010
Dear Ms. Scott:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the 6200 Ultrasound Imaging System, as described in your premarket notification:
## Transducer Model Number
| PA230 | C5-2 R13 |
|-------|----------|
| PA240 | CA123 |
| PA122 | CA430 |
| PA023 | CA431 |
| LA332 | CA541 |
| LA435 | CA631 |
| LA522 | 2CW |
| LA523 | 5CW |
| LA923 | HF CW |
{4}------------------------------------------------
Page 2 - Ms. Scott
| EC123 | IOE323 |
|--------|--------|
| EC1123 | LP323 |
| TRT33 | BC431 |
| TEE022 | BL433 |
| TEE132 | BE1123 |
. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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); 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.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.
Sincerely yours,
Robert R. Be-ker/ (for)
Donald St. Pierre
Donald St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
{5}------------------------------------------------
Indications for Use Statement
# Model 6200 (Modified 6100)
# Indications for Use
Special 510(k) Number (if known):
Device Name:
## 6200 Ultrasound Systems
Esaote's Model 6200 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), 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.
The Virtual Navigator is a MyLab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasound session. The second modality provides additional security in assessing the morphology of the ultrasound image.
Virtual Navigator can be used in the' following application: Abdominal. Musculo-skeletal. Urologic, and Vascular,
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 should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.
Prescription Use X . . . (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Ralu R. Redberg Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-C Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K100931
Esaole, S.p.A.
{6}------------------------------------------------
# 6200 (modiffied 6100)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [4] | Color Velocity Mapping (TVM) | Tissue Enhacement Imaging (TEI) | CnTi | Other (specify) | |
|------------------------------------------------------------|--------------------|---|--------------------|-----|------------------|------------------------|---------------------------------|------------------------------------|------------------------------------|------------------------|------------------------------|---------------------|
| Ophthalmic | P | P | P | P | P | P | P | P | P | | 5, 6, 7, 8, 9 | |
| Total | P | P | P | P | P | P | P | P | P | | 5, 6, 7, 8, 9,<br>12, 13, 15 | |
| Abdominal | P | P | P | P | P | P | P | P | P | | 5, 6, 8, 9,<br>12, 13 | |
| Intraoperative (Abdominal) | P | P | P | P | P | P | P | P | P | | 5, 6, 7, 8, 9,<br>12, 13 | |
| Intraoperative Neurological | P | P | P | P | P | P | P | P | P | | 5, 6, 7, 8, 9,<br>12, 14 | |
| Pediatric | P | P | P | P | P | P | P | P | P | | 5, 6, 8, 9, 12 | |
| Small Organ [1] | P | P | P | P | P | P | P | P | P | | 5, 6, 8, 9, 12 | |
| Conatal Cephalic | P | P | P | P | P | P | P | P | P | | 5, 6, 7, 8, 9,<br>10, 11, 12 | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | | 5, 6, 7, 8, 9,<br>10, 11, 12 | |
| Adult Cardiac | P | P | P | P | P | P | P | P | P | | 5, 6, 8, 9,<br>10, 11, 12 | |
| Pediatric Cardiac | P | P | P | P | P | P | P | P | P | | 5, 6, 8, 9,<br>12, 13, 14 | |
| Transesophageal (Cardiac) | P | P | P | P | P | P | P | P | P | | 5, 6, 8, 9, 12 | |
| Transesophageal (Non Cardiac) | P | P | P | P | P | P | P | P | P | | | |
| Transrectal | P | P | P | P | P | P | P | P | P | | | |
| Transvaginal | P | P | P | P | P | P | P | P | P | | | |
| Transurethral | P | P | P | P | P | P | P | P | P | | | |
| Intravascular | P | P | P | P | P | P | P | P | P | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | | 5, 6, 8, 9,<br>12, 13, 15 | |
| Laparoscopic | P | P | P | P | P | P | P | P | P | | 5, 6, 8, 9,<br>12, 13 | |
| Musculo-skeletal Conventional [3] | P | P | P | P | P | P | P | P | P | | 5, 6, 8, 9,<br>12, 13, 14 | |
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P | P | | 5, 6, 8, 9,<br>12, 13, 14 | |
| Other (Urological) | P | P | P | P | P | P | P | P | P | | 5, 6, 8, 12,<br>13, 15 | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[4] | Color Velocity<br>Mapping (TVM) | Tissue Enhacement<br>Imaging (TEI) | CnTi | Other<br>(specify) | |
| Ophthalmic | P | P | P | P | P | P | P | P | P | | 5, 6, 8, 9, 12 | |
| Fetal | P | P | P | P | P | P | P | | P | | 5, 6, 8, 9, 12, 15 | |
| Abdominal | P | P | P | P | P | P | P | | P | | 5, 6, 8, 9, 12 | |
| Intraoperative (Abdominal) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P | | 5, 6, 8, 9, 12 | |
| Small Organ [1] | P | P | P | P | P | P | P | | P | | 5, 6, 8, 9, 12 | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Adult Cardiac | P | P | P | P | P | P | P | P | P | P | | 6, 8, 9, 10, 11, 12 |
| Pediatric Cardiac | P | P | P | P | P | P | P | P | P | | 6, 8, 9, 10, 11, 12 | |
| Transesophageal (Cardiac) | | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | P | P | P | P | P | P | P | | P | | 5, 6, 8, 9, 12 | |
| Musculo-skeletal Conventional [3] | | | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Color Velocity Mapping (TVM) | Tissue Enhancement Imaging (TEI) | CnTI | Other (specify) | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | | P | | 5, 6, 8, 9 | |
| Abdominal | | P | P | P | P | P | P | | P | | 5, 6, 8, 9 | |
| Intraoperative (Abdominal) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P | | 5, 6, 8, 9 | |
| Small Organ [1] | | P | P | P | P | P | P | | P | | 5, 6, 8, 9 | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | P | P | P | P | P | P | | P | | 5, 6, 8, 9 | |
| Adult Cardiac | | P | P | P | P | P | P | P | P | P | 5, 6, 8, 9 | |
| Pediatric Cardiac | | P | | P | P | P | P | P | P | | 5, 6, 8, 9 | |
| | | | | | | | | | | | | |
| Transesophageal (Cardiac)<br>Transesophageal (Non Cardiac) | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | P | P | P | | P | | 5, 6, 8, 9 | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | | | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | | | |
| | | | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[4] | Color Velocity<br>Mapping (TVM) | Tissue Enhacement<br>Imaging (TEI) | CnTl | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | | P | | 5, 6, 8, 9, 12 | |
| Intraoperative (Abdominal) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P | | 5, 6, 8, 9, 12 | |
| Small Organ [1] | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | | P | | 5, 6, 8, 9, 12 | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac [2] | P | P | P | P | P | P | P | P | P | | 5, 6, 8, 9, 10,<br>11. 12 | |
| Transesophageal (Cardiac) | | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | | 5, 6, 8, 9, 12,<br>15 | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | | | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | | | |
| | | | | | | | | | | | | |
| Clinical Application | Mode of Operations | | | | | | | Color Velocity<br>Mapping (TVM) | Tissue Enhacement<br>Imaging (TEI) | CnTI | Other<br>(specify) | |
| | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[4] | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | | | P | | P | P | P | | P | | 5, 6, 8, 9, 12 | |
| Small Organ [1] | | | | | | | | | | | | |
| Neonatal Cephalic | | | P | | P | P | P | | P | | 5, 6, 8, 9, 12 | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac [2] | | | P | | P | P | P | | P | | 5, 6, 8, 9, 10, 11, 12 | |
| Transesophageal (Cardiac) | | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | P | | P | P | P | | P | | 5, 6, 8, 9, 12 | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | | | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [4] | Color Velocity Mapping (TVM) | Tissue Enhacement Imaging (TEI) | CnTI | Other (specify) | |
| Ophthalmic | P | P | P | P | P | P | P | | | | 6, 8, 9, 12, | |
| Rectal | P | P | P | P | P | P | P | | | | 6, 8, 9, 12, | |
| Abdominal | P | P | P | P | P | P | P | | | | 6, 8, 9, 12, | |
| Intraoperative (Abdominal) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | | | 6, 8, 9, 12, | |
| Small Organ [1] | P | P | P | P | P | P | P | | | | 6, 8, 9, 12, 13, 14 | |
| Neonatal Cephalic | P | P | P | P | P | P | P | | | | 6, 8, 9, 12, | |
| Adult Cephalic<br>Cardiac [2] | E | E | E | E | E | E | E | | E | | 6, 8, 9, 10, 11, 12, 13 | |
| Transesophageal (Cardiac)<br>Transesophageal (Non Cardiac) | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | | 6, 8, 9, 12, | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | P | P | P | P | P | P | P | | P | | 6, 8, 9, 12, 13, 14 | |
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | | P | | 6, 8, 9, 12, 13, 14 | |
| Other (Urological) | P | P | P | P | P | P | P | | P | | 6, 8, 9, 12, | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [4] | Color Velocity Mapping (TVM) | Tissue Enhacement Imaging (TEI) | CnTI | Other (specify) | |
| Ophthalmic | P | P | P | P | P | P | P | P | P | | | |
| Fetal | P | P | P | P | P | P | P | P | P | | 6, 8, 9, 12, | |
| Abdominal | P | P | P | P | P | P | P | P | P | | 6, 8, 9, 12, | |
| Intraoperative (Abdominal) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | | 6, 8, 9, 12, | |
| Small Organ [1] | P | P | P | P | P | P | P | P | P | | 6, 8, 9, 12, | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | | 6, 8, 9, 12, 14.13 | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | | 6, 8, 9, 12, 13.15 | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | P | P | P | | P | P | P | | P | | 6, 8, 9, 12, 13, 14, 15 | |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | | 6, 8, 9, 12, 13, 14, 15 | |
| Other (Urological) | P | P | P | | P | P | P | | P | | 6, 8, 9, 12, | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[4] | Color Velocity<br>Mapping (TVM) | Tissue Enhacement<br>Imaging (TEI) | CnTI | Other<br>(specify) | |
| Ophthalmic | P | P | P | | P | P | P | | | | | |
| Fetal | P | P | P | | P | P | P | | P | | 6, 8, 9, 12, | |
| Abdominal | P | P | P | | P | P | P | | P | | 6, 8, 9, 12, | |
| Intraoperative (Abdominal) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | | 6, 8, 9, 12, | |
| Small Organ [1] | P | P | P | | P | P | P | | P | | 6, 8, 9, 12,<br>13 | |
| Neonatal Cephalic | P | P | P | | P | P | P | | P | | 6, 8, 9, 12,<br>13, 14 | |
| Adult Cephalic | | | | | | | | | | | 6, 8, 9, 12, | |
| Cardiac [2] | | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | | 6, 8, 9, 12,<br>13, 15 | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | P | P | P | | P | P | P | | P | | 6, 8, 9, 12,<br>13, 14, 15 | |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | | 6, 8, 9, 12,<br>13, 14, 15 | |
| Other (Urological) | P | P | P | | P | P | P | | P | | 6, 8, 9, 12, | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [4] | Color Velocity Mapping (TVM) | Tissue Enhacement Imaging (TEI) | CnTI | Other (specify) | |
| Ophthalmic | P | P | P | P | P | P | P | | P | | 6, 8, 9, 12, | |
| Fetal | P | P | P | P | P | P | P | | P | | 6, 8, 9, 12, | |
| Abdominal | P | P | P | P | P | P | P | | P | | 6, 8, 9, 12, | |
| Intraoperative (Abdominal) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P | | 6, 8, 9, 12, | |
| Small Organ [1] | P | P | P | P | P | P | P | | P | | 6, 8, 9, 12, 13, 14 | |
| Neonatal Cephalic | P | P | P | P | P | P | P | | P | | 6, 8, 9, 12, | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac [2] | E | E | E | E | E | E | E | | E | | 6, 8, 9, 10, 11, 12, 13 | |
| Transesophageal (Cardiac) | | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | | 6, 8, 9, 12, 13, 15 | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | P | P | P…
