The following data is part of a premarket notification filed by Philips Healthcare with the FDA for Philips Epiq 5 Diagnostic Ultrasound System, Epiq 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System.
| Device ID | K172607 |
| 510k Number | K172607 |
| Device Name: | Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Philips Healthcare 22100 Bothell Everett Highway Bothell, WA 98021 -8431 |
| Contact | Maxs Newberry |
| 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 | 2017-08-30 |
| Decision Date | 2017-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838088658 | K172607 | 000 |
| 00884838074613 | K172607 | 000 |
| 00884838074194 | K172607 | 000 |
| 00884838070813 | K172607 | 000 |
| 00884838070806 | K172607 | 000 |