The following data is part of a premarket notification filed by Philips Medical Systems North America Co. with the FDA for Xperct.
| Device ID | K060749 |
| 510k Number | K060749 |
| Device Name: | XPERCT |
| Classification | System, X-ray, Angiographic |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 22100 BOTHELL EVERETT HWY. MS 915 Bothell, WA 98041 -3003 |
| Contact | Lynn Harmer |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-03-20 |
| Decision Date | 2006-04-04 |
| Summary: | summary |