The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Epiq 5 Diagnostic Ultrasound System; Epiq 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System.
| Device ID | K163120 |
| 510k Number | K163120 |
| Device Name: | EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic 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 | Peng Cui Philips Ultrasound, Inc. 3000 Minuteman Road Andover, MA 01810 |
| 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 | No |
| Combination Product | No |
| Date Received | 2016-11-08 |
| Decision Date | 2017-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838069718 | K163120 | 000 |