The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Panorama 1.0t.
| Device ID | K041602 |
| 510k Number | K041602 |
| Device Name: | PANORAMA 1.0T |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 22100 BOTHELL EVERETT HWY P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Contact | Joseph S Arnaudo |
| Correspondent | Joseph S Arnaudo PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 22100 BOTHELL EVERETT HWY P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-14 |
| Decision Date | 2004-07-26 |
| Summary: | summary |