The following data is part of a premarket notification filed by Philips Ultrasound Inc. with the FDA for Percunav Image Fusion And Interventional Navigation.
| Device ID | K170716 |
| 510k Number | K170716 |
| Device Name: | PercuNav Image Fusion And Interventional Navigation |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Philips Ultrasound Inc. 3000 Minuteman Road Andover, MA 01810 |
| Contact | Peng Cui |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | JAK |
| Subsequent Product Code | IYO |
| Subsequent Product Code | LLZ |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-03-09 |
| Decision Date | 2017-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838080720 | K170716 | 000 |