K063559 is an FDA 510(k) clearance for the ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5. This device is classified as a System, Nuclear Magnetic Resonance Imaging (Class II - Special Controls, product code LNH).
Submitted by Philips Medical Systems (Bothell, US). The FDA issued a Cleared decision on January 4, 2007, 38 days after receiving the submission on November 27, 2006.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K063559 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 2006 |
| Decision Date | January 04, 2007 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LNH — System, Nuclear Magnetic Resonance Imaging |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1000 |