IYN — System, Imaging, Pulsed Doppler, Ultrasonic Class II
FDA product code IYN covers "System, Imaging, Pulsed Doppler, Ultrasonic", a Class II medical device regulated under 21 CFR 892.1550. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IYN
- Device Class
- Class II
- Regulation Number
- 892.1550
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261313 | ge medical systems ultrasound and primary care diagnostics | Vivid Explorer/Vivid Advanced/Vivid Focus | September 2, 2026 |
| K254027 | sonoscape medical | Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo | August 24, 2026 |
| K261668 | ge medical systems ultrasound and primary care diagnostics | Venue Go | August 7, 2026 |
| K262311 | philips ultrasound | Alturion Series Diagnostic Ultrasound System | August 4, 2026 |
| K261288 | imgfax co | Handheld Ultrasound Scanner | July 30, 2026 |
| K261835 | ge medical systems ultrasound and primary care diagnostics | LOGIQ Focus | July 30, 2026 |
| K261412 | samsung medison co | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound Sy | July 28, 2026 |
| K261211 | philips ultrasound | Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagno | July 27, 2026 |
| K261081 | beijing konted medical technology co | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) | July 23, 2026 |
| K261272 | esonic technology (wuhan) co | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePa | July 23, 2026 |
| K260667 | philips ultrasound | Alturion Series Diagnostic Ultrasound System | June 29, 2026 |
| K260844 | siemens medical solutions usa | ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ult | June 16, 2026 |
| K260748 | e-scopics | ES-Series | June 9, 2026 |
| K260680 | philips ultrasound | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound | May 27, 2026 |
| K260123 | philips ultrasound | EPIQ Series Diagnostic Ultrasound System | May 27, 2026 |
| K260398 | ge medical systems ultrasound and primary care diagnostics | LOGIQ e | May 26, 2026 |
| K253949 | chison medical technologies co | SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 | May 22, 2026 |
| K253720 | wuhan united imaging healthcare co | uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE | May 21, 2026 |
| K253716 | wuhan united imaging healthcare co | uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis | May 15, 2026 |
| K254028 | sonoscape medical | Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra | May 15, 2026 |