K052078 is an FDA 510(k) clearance for the ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES. This device is classified as a System, Nuclear Magnetic Resonance Imaging (Class II - Special Controls, product code LNH).
Submitted by Philips Medical Systems Nederland B.V. (Bothell, US). The FDA issued a Cleared decision on September 7, 2005, 37 days after receiving the submission on August 1, 2005.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K052078 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2005 |
| Decision Date | September 07, 2005 |
| Days to Decision | 37 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 |