The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Achieva, Intera And Panorama 1.0t, Release 2.5.
| Device ID | K063559 |
| 510k Number | K063559 |
| Device Name: | ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PHILIPS MEDICAL SYSTEMS 22100 BOTHELL EVERETT HWY Bothell, WA 98021 -8431 |
| Contact | Joseph S Arnaudo |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-11-27 |
| Decision Date | 2007-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838068452 | K063559 | 000 |
| 00884838068445 | K063559 | 000 |
| 00884838068308 | K063559 | 000 |
| 00884838068292 | K063559 | 000 |
| 00884838068285 | K063559 | 000 |
| 00884838055292 | K063559 | 000 |