The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Epiq Diagnostic Ultrasound System, 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 | K182857 |
| 510k Number | K182857 |
| Device Name: | EPIQ Diagnostic Ultrasound System, 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 Ultrasound, Inc. 22100 Bothell Everett Highway Bothell, WA 98021 -8431 |
| 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 | 2018-10-10 |
| Decision Date | 2018-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838090804 | K182857 | 000 |
| 00884838088573 | K182857 | 000 |
| 00884838088160 | K182857 | 000 |