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 |
|---|---|---|---|
| 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 |
| K260111 | mytech intelligence (shenzhen) co | Palmtop Ultrasound Diagnostic System (MT10P/MT10) | May 14, 2026 |
| K260846 | shenzhen mindray bio-medical electronics co | Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnosti | May 11, 2026 |
| K261132 | healium intelliscan corporation | Healium Intelliscan LX192LC | May 5, 2026 |
| K252558 | philips ultrasound | Lumify Diagnostic Ultrasound System | May 5, 2026 |
| K260589 | e-scopics | ES-Series | April 29, 2026 |
| K253288 | esaote | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | April 6, 2026 |
| K252709 | xuzhou yongkang electronic science technology co | Wireless Probe Type Ultrasound Scanner | April 2, 2026 |
| K253595 | philips ultrasound | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound | March 27, 2026 |
| K254099 | samsung medison co | EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO | March 27, 2026 |
| K252148 | butterfly network | Butterfly Gestational Age Tool | March 27, 2026 |