The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Epiq , Epiq 5, Epiq 7, Affiniti 30, Affiniti 50 And Affiniti 70 Diagnostic Ultrasound System.
| Device ID | K181485 |
| 510k Number | K181485 |
| Device Name: | EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 And Affiniti 70 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Philips Ultrasound, Inc. 22100 Bothell-Everett Hwy Bothell, WA 98021 |
| Contact | Kym Rupp |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-06-06 |
| Decision Date | 2018-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838086609 | K181485 | 000 |