6440 Ultrasound System
Device Facts
| Record ID | K173291 |
|---|---|
| Device Name | 6440 Ultrasound System |
| Applicant | Esaote, S.p.A. |
| Product Code | IYN · Radiology |
| Decision Date | Jan 12, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
Esaote's Model 6440 is intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Pediatric, Small organs, Neonatal, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel. The 6440 system 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 Virtual Navigator software option for Esaote model 6440 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 real time ultrasound image. Virtual Navigator can be used in the following applications: 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 be 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 system (MyLab9 eXP) for diagnostic general ultrasound studies; performs B-Mode, M-Mode, Doppler (PW/CW), Color Flow Mapping, Amplitude Doppler, Tissue Velocity Mapping, 3D/4D, and elastosonography. Virtual Navigator software integrates second-modality images (CT, MR, US, PET) for procedural guidance (biopsy, needle/catheter placement, nerve blocks). Operated by clinicians in clinical settings. System includes LCD display, QWERTY keyboard, and touchscreen controls. Drives phased, convex, Doppler, and volumetric probes. Stores data internally or via LAN/USB. Auto EF and QPack features provide automated measurements. Benefits include enhanced anatomical visualization and procedural guidance.
Clinical Evidence
Bench testing only. Performance data includes biocompatibility (ISO 10993), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and acoustic output measurement (NEMA UD 2/UD 3). Software verification and validation conducted per FDA guidance for moderate level of concern.
Technological Characteristics
Mainframe ultrasound system; LCD display; phased, convex, Doppler, and volumetric probes. Modes: B, M, PW/CW Doppler, CFM, AD, TVM, 3D/4D, Elastosonography. Connectivity: LAN, USB, internal HDD, DVD-RW. Software: Virtual Navigator, Auto EF, QPack. 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 in fetal, abdominal, intraoperative, pediatric, small organ, neonatal, cephalic, transvaginal, musculoskeletal, urological, cardiovascular, and peripheral vascular applications. Contraindicated for patients/personnel using electronic life support devices (e.g., pacemakers) when using the Virtual Navigator tracking system.
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
Reference Devices
Related Devices
- K192157 — 6450 Ultrasound system · Esaote, S.p.A. · Nov 22, 2019
- K212021 — 6430 MyLabX75, 6430 MyLab XPro75 · Esaote, S.p.A. · Sep 16, 2021
- K103152 — 6250 ULTRASOUND SYTEMS · Esaote, S.p.A. · Jan 7, 2011
- K161168 — MyLabSix Ultrasound System · Esaote Europe B.V. · Sep 2, 2016
- K153277 — 6200 Ultrasound System and 6250 Ultrasound System · Esaote, S.p.A. · May 4, 2016
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 12, 2018
Esaote S.p.A. % Allison Scott, RAC Associate Director Navigant Consulting, Inc. 9100 Kevstone Crossing, Suite 500 INDIANAPOLIS IN 46240
Re: K173291
Trade/Device Name: 6440 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: October 13, 2017 Received: October 16, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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)
### K173291
Device Name 6440 Ultrasound System
### Indications for Use (Describe)
Esaote's Model 6440 is intended to perform diagnostic general ultrasound studies
including: Fetal, Abdominal, Intraoperative (Abdominal), Pediatric, Small organs, Neonatal Cephalic, Adult Cephalic, Transrectal, Transvaginal, Musculoskeletal (Conventional), Musculosketal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel.
The 6440 system 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 Virtual Navigator software option for Esaote model 6440 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 real time ultrasound image. Virtual Navigator can be used in the following applications: 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 be 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).
Type of Use (Select one or both, as applicable)
| <div> <span style="font-size:10pt;">区</span>Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|---------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:10pt;">□</span>Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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## 6440
ntended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | | |
|-------------------------------------------------------------------------------------------------------|---|---|---------------------------------------------|-----|------------------|------------------------------|--------------------|---------------------------------|---------------------------|---------------------------|--|--|
| Ophthalmic | N | N | N | N | N | N | N | N | N | N: 5, 6, 7, 11 | | |
| Fetal | N | N | N | N | N | N | N | N | N | N: 5, 6, 7, 8, 10, 11, 12 | | |
| Abdominal | N | N | N | N | N | N | N | N | N | N: 5, 6, 7, 8, 11 | | |
| Intraoperative (Abdominal) | N | N | N | N | N | N | N | N | N | N: 5, 6, 7, 11 | | |
| Intraoperative Neurological | N | N | N | N | N | N | N | N | N | N: 5, 6, 7, 8, 11 | | |
| Pediatric | N | N | N | N | N | N | N | N | N | N: 5, 6, 7 | | |
| Small Organs [1] | N | N | N | N | N | N | N | N | N | N: 5, 6, 7 | | |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N: 5, 6, 7 | | |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N: 5, 6, 7 | | |
| Cardiac [2] | N | N | N | N | N | N | N | N | N (9) | N: 5, 6, 7 | | |
| Transesophageal (Cardiac) | N | N | N | N | N | N | N | N | N | N: 5, 6, 7, 8, 11 | | |
| Transesophageal (Non Cardiac) | N | N | N | N | N | N | N | N | N | N: 5, 6, 7, 8, 11 | | |
| Transrectal | N | N | N | N | N | N | N | N | N | N: 5, 6, 7, 11 | | |
| Transvaginal | N | N | N | N | N | N | N | N | N | N: 5, 6, 7, 8, 11 | | |
| Transurethral | N | N | N | N | N | N | N | N | N | N: 5, 6, 7, 11 | | |
| Intravascular | N | N | N | N | N | N | N | N | N | N: 5, 6, 7, 8, 11 | | |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N: 5, 6, 7, 8, 11 | | |
| Laparoscopic | N | N | N | N | N | N | N | N | N | N: 5, 6, 7, 8, 11 | | |
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | N | N: 5, 6, 7, 8, 11 | | |
| Musculo-skeletal Superficial [3] | N | N | N | N | N | N | N | N | N | N: 5, 6, 7, 8, 11 | | |
| Other (Urological) | N | N | N | N | N | N | N | N | N | N: 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 | | | | | | | | | | |
| Fetal | P | P | | | P | P | P | | | P: 5, 7, 11 | | |
| Abdominal | P | P | P | | P | P | P | | P | P: 5, 7, 8, 10, 11, 12 | | |
| Intraoperative (Abdominal) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | P: 5, 7, 11 | | |
| 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, 7, 11 | | |
| Laparoscopic | | | | | | | | | | P: 5, 7, 11 | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | | P | P: 5, 7, 11 | | |
| Musculo-skeletal Superficial | | | | | | | | | | P: 5, 7, 11 | | |
| Other (Urological, Gynecological) | P | P | P | | P | P | P | | P | P: 5, 7, 11 | | |
| | | | | | | | Mode of Operations | | | | | |
| 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 | | | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | | P | P: 5, 7, 11 | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Transvascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | |
| Other (Urological, Gynecological) | P | P | P | | P | P | P | | P | P: 5, 7, 8, 11 | | |
| Η 6-18<br>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] | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | | P | P | | P | P | P | | P | P: 5, 7 | | |
| Small Organs [1] | | P | P | | P | P | P | | P | P: 5, 7, 8 | | |
| Neonatal Cephalic | | P | P | | P | P | P | | P | P: 5, 7 | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | P | P | | P | P | P | | P | P: 5, 7 | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | P | P | | P | P | P | | P | P: 5, 7, 8 | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Tissue Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | | |
| Ophthalmic | E | E | E | E | E | E | E | | E | E: 5, 7 | | |
| Foetal | E | E | E | E | E | E | E | | E | E: 5, 7, 8, 10 | | |
| Abdominal | E | E | E | E | E | E | E | | E | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Paediatric | E | E | E | E | E | E | E | | E | E: 5, 7 | | |
| Small Organs [1] | E | E | E | E | E | E | E | | E | E: 5, 7, 8 | | |
| Neonatal Cephalic | E | E | E | E | E | E | E | | E | E: 5, 7 | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | E | E | E | E | E | E | E | | E | E: 5, 7 | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Conventional | E | E | E | E | E | E | E | | E | E: 5, 7, 8 | | |
| Musculo-skeletal Superficial | E | E | E | E | E | E | E | | E | E: 5, 7, 8 | | |
| Other | | | | | | | | | | | | |
| | | | | | | | 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 | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | | P | P: 5, 7, 10, 11 | | |
| Intraoperative (Abdominal) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | P: 5, 7, 11 | | |
| Small Organs [1] | P | P | P | | P | P | P | | P | P: 5, 7, 11 | | |
| Neonatal Cephalic | P | P | P | | P | P | P | | P | P: 5, 7, 11 | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | P: 5, 7, 11 | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | | P | P: 5, 7, 8, 11 | | |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | | P | P: 5, 7, 8, 11 | | |
| Other | | | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | N | N | N | | N | N | N | | N | N: 5, 7, 11 | | |
| Small Organs [1] | N | N | N | | N | N | N | | N | N: 5, 7, 8, 11 | | |
| Neonatal Cephalic | N | N | N | | N | N | N | | N | N: 5, 7, 11 | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | N | N | N | | N | N | N | | N | N: 5, 7, 11 | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Conventional | N | N | N | | N | N | N | | N | N: 5, 7, 8, 11 | | |
| Musculo-skeletal Superficial | N | N | N | | N | N | N | | N | N: 5, 7, 8, 11 | | |
| Other | | | | | | | | | | | | |
| | | | | | | | ode of Operation | | | | | |
| nical Applicat | ದ | N | PWD | CWD | Color Doppler | mplitude Doppler (PD) | Combined [4] | Color Velocity Mapping (TVM | Harmonic maging (TE) | Other (specif | | |
| Ophthalmi | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdomina | N | N | N | N | N | N | N | | N | N: 5, 7, 10, | | |
| traoperative (Abdominal) | | | | | | | | | | | | |
| raoperative Neurologica | | | | | | | | | | | | |
| Pediatric | N | N | N | N | N | N | N | | N | N: 5, 7, 11 | | |
| Small Organs [ | N | N | N | | N | N | N | | N | N: 5, 7, 8, 11 | | |
| eonatal Cephal | N | N | N | | N | N | N | | N | N: 5, 7, 11 | | |
| dult Cephalic | | | | | | | | | | | | |
| ardiac [2] | N | N | N | | N | N | N | N | N | 5, 7, 11<br>デ | | |
| ansesophageal (Cardiac | | | | | | | | | | | | |
| iac)<br>nsesophageal (Non Care | | | | | | | | | | | | |
| ansrecta | | | | | | | | | | | | |
| ansvagina | | | | | | | | | | | | |
| ansurethra | | | | | | | | | | | | |
| ntravascula: | | | | | | | | | | | | |
| eripheral Vascula | N | N | N | | N | N | N | | N | 5, 7, 11<br>ジ | | |
| iparoscopic | | | | | | | | | | | | |
| nal<br>usculo-skeletal Convent | | | | | | | | | | | | |
| Musculo-skelet Superficial | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| : New indication; P: Previo | | | usly cleared by FDA; E:Added under Appendix | ದ | | | | | | | | |
| | | | | | | | ode of Operation | | | | | |
| nical Applicati | ਸ | M | PWD | CWD | Color Doppler | mplitude Doppler (PD) | Combined<br>[サ] | Color Velocity Tapping (TVM | Harmonic maging (TE) | Other (specif | | |
| Ophthalmi | | | | | | | | | | | | |
| Feta | | | | | | | | | | | | |
| Abdomina | N | N | N | N | N | N | N | | N | N: 7, 10, | | |
| traoperative (Abdominal | | | | | | | | | | | | |
| raoperative Neurologic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organs | | | | | | | | | | | | |
| eonatal Cephal | | | | | | | | | | | | |
| Adult Cephalic | N | N | N | N | N | N | N | | N | N: 7, 11 | | |
| Cardiac [2] | N | N | N | N | N | N | N | N | N | N: 7, 11 | | |
| ansesophageal (Cardiac) | | | | | | | | | | | | |
| ac)<br>nsesophageal (Non Card | | | | | | | | | | | | |
| ransrecta | | | | | | | | | | | | |
| ransvagina | | | | | | | | | | | | |
| ansurethra | | | | | | | | | | | | |
| ntravascula | | | | | | | | | | | | |
| eripheral Vascula | N | N | N | N | N | N | N | | N | N: 7, 11 | | |
| aparoscopic | | | | | | | | | | | | |
| nal<br>usculo-skeletal Conventi | | | | | | | | | | | | |
| Musculo-skelet Superficial | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| New indication; P: Previo | | | usly cleared by FDA; E:Added under Appendix | ದ | | | | | | | | |
| 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 | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac [2]…
