The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Epiq 5 Diagnostic Ultrasound System, Epiq 7diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System.
| Device ID | K160807 |
| 510k Number | K160807 |
| Device Name: | EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | PHILIPS ULTRASOUND, INC. 3000 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Peng Cui |
| 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 | 2016-03-24 |
| Decision Date | 2016-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838074187 | K160807 | 000 |
| 00884838097957 | K160807 | 000 |
| 00884838097742 | K160807 | 000 |