The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Achieva, Intera And Panorama 1.0 Release 2-series.
| Device ID | K052078 |
| 510k Number | K052078 |
| Device Name: | ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 22100 BOTHELL EVERETT HIGHWAY P.O. BOX 3003 Bothell, WA 98041 -8431 |
| Contact | Lynn Harmer |
| Correspondent | Lynn Harmer PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 22100 BOTHELL EVERETT HIGHWAY P.O. BOX 3003 Bothell, WA 98041 -8431 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-01 |
| Decision Date | 2005-09-07 |
| Summary: | summary |