The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Heartnavigator Release 1.
| Device ID | K111245 |
| 510k Number | K111245 |
| Device Name: | HEARTNAVIGATOR RELEASE 1 |
| Classification | System, Image Processing, Radiological |
| Applicant | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 22100 BOTHELL EVERETT HIGHWAY Bothell, WA 98021 -8431 |
| Contact | Lynn Harmer |
| Correspondent | Lynn Harmer PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 22100 BOTHELL EVERETT HIGHWAY Bothell, WA 98021 -8431 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-03 |
| Decision Date | 2011-07-29 |
| Summary: | summary |