K253595 is an FDA 510(k) clearance for the EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System. This device is classified as a System, Imaging, Pulsed Doppler, Ultrasonic (Class II - Special Controls, product code IYN).
Submitted by Philips Ultrasound, LLC (Bothell, US). The FDA issued a Cleared decision on March 27, 2026, 129 days after receiving the submission on November 18, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1550.
| 510(k) Number | K253595 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 2025 |
| Decision Date | March 27, 2026 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYN - System, Imaging, Pulsed Doppler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1550 |