K071179 is an FDA 510(k) clearance for the NORAS OR HEAD HOLDER. This device is classified as a Coil, Magnetic Resonance, Specialty (Class II - Special Controls, product code MOS).
Submitted by Siemens Medical Solutions USA, Inc. (Mavern, US). The FDA issued a Cleared decision on June 13, 2007, 47 days after receiving the submission on April 27, 2007.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K071179 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2007 |
| Decision Date | June 13, 2007 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MOS — Coil, Magnetic Resonance, Specialty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1000 |