The following data is part of a premarket notification filed by Philips Healthcare with the FDA for Xperius Ultrasound System.
| Device ID | K163020 |
| 510k Number | K163020 |
| Device Name: | Xperius Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | PHILIPS HEALTHCARE 22100 BOTHELL EVERETT HIGHWAY Bothell, WA 98021 -8431 |
| Contact | Scott Zhang |
| 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 | 2016-10-31 |
| Decision Date | 2016-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838083165 | K163020 | 000 |
| 00884838072312 | K163020 | 000 |
| 00884838072305 | K163020 | 000 |