Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System
Device Facts
| Record ID | K182715 |
|---|---|
| Device Name | Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System |
| Applicant | Shenzhen Wisonic Medical Technology Co. , Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Nov 20, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid, etc.), neonatal cephalic, transcranial, cardiac, transvaginal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams.
Device Story
Touch-screen controlled diagnostic ultrasound system; acquires/displays ultrasound data in B-Mode, Color Flow Doppler, Pulsed Wave Doppler, Continuous Wave Doppler, and Power/Dirpower modes. System includes main unit, probes, probe extender, power adapter, and mobile trolley. Used by healthcare professionals in clinical settings to visualize anatomical structures, perform measurements, and utilize software analysis packages for diagnostic decision-making. Benefits include non-invasive diagnostic imaging and fluid flow assessment. New features include screen rotation, ECG module, and Ethernet port.
Clinical Evidence
No clinical studies were required. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and performance testing (IEC 60601-2-37) to evaluate measurement accuracy and system sensitivity.
Technological Characteristics
Touch-screen controlled ultrasound system. Probes: C5-2, C5-2B, P7-3, L15-4B, L10-5. Modes: B, M, PW, CW, Color Doppler, Power/Dirpower. Connectivity: Ethernet port. Power: External adapter. Biocompatibility: ISO 10993-1. Safety: IEC 60601-1, IEC 60601-2-37. EMC: IEC 60601-1-2.
Indications for Use
Indicated for adults, pregnant women, pediatric patients, and neonates for diagnostic ultrasound imaging and fluid flow analysis in gynecology, obstetric, abdominal, pediatric, small parts, neonatal cephalic, transcranial, cardiac, transvaginal, peripheral vascular, urology, orthopedic, and musculoskeletal exams.
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
- Navi e/ Navi X Diagnostic Ultrasound System (K180461)
Related Devices
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- K233697 — SonoMax Series Digital Color Doppler Ultrasound System · CHISON Medical Technologies Co., Ltd. · Aug 9, 2024
- K191347 — Paragon XHD Diagnostic Ultrasound System · Shenzhen Wisonic Medical Technology Co. , Ltd. · Feb 7, 2020
- K201462 — ACUSON Sequoia Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Jun 24, 2020
- K193257 — ACUSON Sequoia Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Jan 31, 2020
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 ADMINISTRATION" in blue.
November 20, 2018
Shenzhen Wisonic Medical Technology Co., Ltd. Jiang Xiaosan Regulatory Engineer 1st and 5th Floor, No. 6 Building, Pingshan Tech Park, Taoyuan Street, Nanshan SHENZHEN, 518055 CHINA
Re: K182715
Trade/Device Name: Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN Dated: September 27, 2018 Received: September 27, 2018
Dear Jiang Xiaosan:
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 mav, 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 avare 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (OS) 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 mediation-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) K182715
Device Name
Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System
Indications for Use (Describe)
The Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid, etc.), neonatal cephalic, transcranial, cardiac, transvaginal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image contains the word "wisonic" in red font. The font is bold and sans-serif. The word is written in lowercase letters. The background is white.
Diagnostic Ultrasound System System:
Probe: N/A
| Clinical Application | | Mode of Operation | | | | | | | | |
|----------------------------------------------------------------------------------------------------|------------------------------------|--------------------------|---|---------|---------|------------------|----------------------|---------------------------|-----------------------|-----------------|
| General<br>(Track<br>Only) | Specific (Track 1 & 3) | B | M | PW<br>D | CW<br>D | Color<br>Doppler | Amplitude<br>Doppler | Combine<br>d<br>(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | N | N | N | | N | N | N | Note 1, 4 | |
| | Abdominal | N | N | N | N | N | N | N | Note 1, 4 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N | Note 1,4 | |
| | Small Organ (Specify**) | N | N | N | | N | N | N | Note 1,4 | |
| Fetal | Neonatal Cephalic | N | N | N | N | N | N | N | Note 1,4 | |
| Imaging<br>& | Adult Cephalic | N | N | N | N | N | N | N | Note 1,4 | |
| Other | Trans-rectal | N | N | N | | N | N | N | Note 1,4 | |
| | Trans-vaginal | N | N | N | | N | N | N | Note 1,4 | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | N | Note 1,4 | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | N | Note 1,4 | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | N | N | N | N | N | N | N | Note 1,4 | |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | N | N | Note 1,4 | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | N | N | N | N | N | N | Note 1,4 | | |
| | Other (Specify***) | N | N | N | N | N | N | Note 1,4 | | |
| General<br>(Track<br>Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | P | P | P | P | P | P | P | Note 1, 4 | |
| | Intra-operative<br>(Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P | Note 1,4 | |
| | Small<br>Organ<br>(Specify**) | | | | | | | | | |
| Fetal<br>Imaging<br>& | Neonatal Cephalic | P | P | P | P | P | P | P | Note 1,4 | |
| Other | Adult Cephalic | P | P | P | P | P | P | P | Note 1,4 | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P | Note 1,4 | |
| | Cardiac Pediatric | P | P | P | P | P | P | P | Note 1,4 | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral vessel | Peripheral vessel | | | | | | | | | |
| | Other (Specify***) | | | | | | | | | |
| N=new indication; P=previously cleared by FDA; E=added under this appendix | | | | | | | | | | |
| Additional comments: Combined modes--B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B. | | | | | | | | | | |
| *Intraoperative includes abdominal, thoracic, and vascular etc. | | | | | | | | | | |
| **Small organ-breast, thyroid, testes. | | | | | | | | | | |
| ***Other use includes Urology. | | | | | | | | | | |
| Note1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | | |
| Note2: 4D(Real-time 3D) | | | | | | | | | | |
| Note3: TDI | | | | | | | | | | |
| Note4: Biopsy Guidance | | | | | | | | | | |
| Note5: Anatomic M | | | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | | |
| Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | | | |
| | General<br>(Track<br>Only) | 1 Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | P | P | P | P | P | P | P | Note 1, 4 | |
| | Intra-operative<br>(Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| Fetal<br>Imaging<br>&<br>Other | Pediatric | P | P | P | P | P | P | P | Note 1 | |
| | Small Organ (Specify**) | | | | | | | | | |
| | Neonatal Cephalic | P | P | P | P | P | P | P | Note 1 | |
| | Adult Cephalic | P | P | P | P | P | P | P | Note 1 | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | P | P | P | P | P | P | P | Note 1 | |
| | Intravascular | | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P | Note 1 | |
| | Cardiac Pediatric | P | P | P | P | P | P | P | Note 1 | |
| | Intravascular (Cardiac) | | | | | | | | | |
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Additional comments: Combined modes-B+M, PW+B, Color + B, PW +Color+B, PW +Color+B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note2: 4D(Real-time 3D)
Note3: TDI
Note4: Biopsy Guidance
Note5: Anatomic M
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
### Concurrence of CDRH, Office of Device Evaluation(ODE)
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System: Diagnostic Ultrasound System
P4-1 Probe:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
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Page 4 of 20 510(k) Premarket Notification Submission
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Diagnostic Ultrasound System System:
P7-3 Probe:
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| | Trans-esoph. (Cardiac) | | | | |
|----------------------|------------------------|--|--|--|--|
| | Intra-cardiac | | | | |
| Peripheral<br>vessel | Peripheral vessel | | | | |
| | Other (Specify***) | | | | |
Additional comments: Combined modes--B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Notel: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note2: 4D(Real-time 3D)
Note3: TDI
Note4: Biopsy Guidance
Note5: Anatomic M
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
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Image /page/9/Picture/0 description: The image shows the word "wisonic" in red font. The font is bold and sans-serif. The letters are closely spaced together. The background is white.
Diagnostic Ultrasound System System:
Probe: L15-4NB/L15-4B
| Clinical Application | | | Mode of Operation | | | | | | |
|---------------------------------|------------------------------------|-------------------|-------------------|-----|-----|------------------|----------------------|-----------------------|--------------------|
| General<br>(Track<br>1<br>Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative<br>(Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P | Note 1,4 |
| | Small Organ (Specify**) | P | P | P | P | P | P | P | Note 1,4 |
| Fetal<br>Imaging &<br>Other | Neonatal Cephalic | P | P | P | P | P | P | P | Note 1,4 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | P | P | P | P | Note 1,4 |
| | Musculo-skeletal<br>(Superficial) | P | P | P | P | P | P | P | Note 1,4 |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | P | P | P | Note 1,4 | |
| | Other (Specify***) | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | | |
| General<br>(Track<br>1<br>Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative<br>(Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N | Note 1,4 |
| | Small Organ (Specify**) | N | N | N | N | N | N | N | Note 1,4 |
| Fetal<br>Imaging &<br>Other | Neonatal Cephalic | N | N | N | N | N | N | N | Note 1,4 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | N | N | N | N | Note 1,4 |
| | Musculo-skeletal<br>(Superficial) | N | N | N | N | N | N | N | Note 1,4 |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
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Additional comments: Combined modes--B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Notel: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note2: 4D(Real-time 3D)
Note3: TDI
Note4: Biopsy Guidance
Note5: Anatomic M
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
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Image /page/11/Picture/0 description: The image shows the word "wisonic" in red font. The font is a bold sans-serif typeface. The word is presented on a white background. The letters are evenly spaced and appear to be part of a logo or brand name.
Diagnostic Ultrasound System System:
Probe: L10-5
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| | Trans-esoph. (Cardiac) | | | | | | |
|----------------------|------------------------|---|---|---|---|---|----------|
| | Intra-cardiac | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | N | N | N | N | N | Note 1,4 |
| | Other (Specify***) | | | | | | |
Additional comments: Combined modes--B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Notel: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note2: 4D(Real-time 3D)
Note3: TDI
Note4: Biopsy Guidance
Note5: Anatomic M
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
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Image /page/13/Picture/0 description: The image shows the word "wisonic" in red font. The font is a sans-serif font, and the letters are all lowercase. The word is slightly italicized. The background is white.
System:
Intended Use:
Diagnostic Ultrasound System
Probe: LH15-6
| Clinical Application | | | Mode of Operation | | | | | | |
|---------------------------------|------------------------------------|-------------------|---------------------------|---------------------------|---------|------------------|--------------------------|---------------------------|--------------------|
| | | | General<br>(Track 1 Only) | Specific (Track 1 &<br>3) | B | M | PWD | CWD | Color<br>Doppler |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative<br>(Specify*) | P | P | P | | P | P | P | Note 1 |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,4 |
| | Small<br>Organ<br>(Specify**) | P | P | P | | P | P | P | Note 1,4 |
| Fetal Imaging<br>& Other | Neonatal Cephalic | P | P | P | | P | P | P | Note 1,4 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | | P | P | P | Note 1,4 |
| | Musculo-skeletal<br>(Superficial) | P | P | P | | P | P | P | Note 1,4 |
| | Intravascular | | | | | | | | |
| Cardiac | Intravascular | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular<br>(Cardiac) | | | | | | | | |
| | Trans-esoph.<br>(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | P | P | P | Note 1,4 | |
| | Other (Specify***) | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | | |
| General<br>(Track<br>1<br>Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | N | N | N | | N | N | N | Note 1, 4 |
| | Abdominal | N | N | N | | N | N | N | Note 1, 4 |
| | Intra-operative<br>(Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | Note 1,4 |
| | Small Organ (Specify**) | | | | | | | | |
| Fetal<br>Imaging &<br>Other | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | N | N | N | N | N | N | Note 1,4 | |
| | Other (Specify***) | | | | | | | | |
| Clinical Application | | | Mode of Operation | | | | | | |
| General<br>(Track<br>1<br>Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | N | N | N | | N | N | N | Note 1, 4 |
| | Abdominal | N | N | N | | N | N | N | Note 1, 4 |
| | Intra-operative<br>(Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | Note 1,4 |
| | Small Organ (Specify**) | | | | | | | | |
| Fetal<br>Imaging &<br>Other | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | N | N | N | N | N | N | Note 1,4 | |
| | Other (Specify***) | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | | |
| General<br>(Track<br>1<br>Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | Note 1 |
| | Abdominal | P | P | P | | P | P | P | Note 1 |
| | Intra-operative<br>(Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1 |
| | Small Organ (Specify**) | | | | | | | | |
| Fetal<br>Imaging &<br>Other | Neonatal Cephalic | P | P | P | | P | P | P | Note 1 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | P | P | P | | P | P | P | Note 1 |
| Cardiac | Cardiac Pediatric | P | P | P | | P | P | P | Note 1 |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | | P | P | Note 1,4 | |
| | Other (Specify***) | | | | | | | Note 1,4 | |
| Clinical Application | | Mode of Operation | | | | | | | |
| General<br>(Track<br>1<br>Only) | Specific (Track 1 & 3) | B | M | PW<br>D | CW<br>D | Color<br>Doppler | Amplitud<br>e<br>Doppler | Combine<br>d<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | Note 1, 4 |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify**) | | | | | | | | |
| Fetal<br>Imaging<br>&<br>Other | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | P | Note 1,4 |
| | Trans-vaginal | P | P | P | | P | P | P | Note 1,4 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | |…
