The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Epiq Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System.
| Device ID | K211597 |
| 510k Number | K211597 |
| Device Name: | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Philips Medical Systems 22100 Bothell Everett HWY Bothell, WA 98021 |
| Contact | Brenna Loufek |
| Correspondent | Tamara Daniels Philips Medical Systems 22100 Bothell Everett HWY Bothell, WA 98021 |
| 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 | No |
| Combination Product | No |
| Date Received | 2021-05-24 |
| Decision Date | 2021-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838107540 | K211597 | 000 |
| 00884838106567 | K211597 | 000 |
| 00884838113961 | K211597 | 000 |
| 00884838113923 | K211597 | 000 |
| 00884838113909 | K211597 | 000 |
| 00884838113886 | K211597 | 000 |
| 00884838113862 | K211597 | 000 |
| 00884838113848 | K211597 | 000 |
| 00884838113824 | K211597 | 000 |
| 00884838114470 | K211597 | 000 |
| 00884838114463 | K211597 | 000 |
| 00884838114456 | K211597 | 000 |
| 00884838106574 | K211597 | 000 |
| 00884838106581 | K211597 | 000 |
| 00884838106598 | K211597 | 000 |
| 00884838107533 | K211597 | 000 |
| 00884838107526 | K211597 | 000 |
| 00884838107519 | K211597 | 000 |
| 00884838107502 | K211597 | 000 |
| 00884838107489 | K211597 | 000 |
| 00884838107465 | K211597 | 000 |
| 00884838107458 | K211597 | 000 |
| 00884838107441 | K211597 | 000 |
| 00884838106628 | K211597 | 000 |
| 00884838106611 | K211597 | 000 |
| 00884838106604 | K211597 | 000 |
| 00884838111004 | K211597 | 000 |