The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Philips Epiq Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System.
| Device ID | K212704 |
| 510k Number | K212704 |
| Device Name: | Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Philips Medical Systems 22100 Bothell Everett HWY Bothell, WA 98021 |
| Contact | Brenna Loufek |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| Subsequent Product Code | OBJ |
| Subsequent Product Code | QIH |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-08-26 |
| Decision Date | 2021-09-24 |