K110942 is an FDA 510(k) clearance for the PICA WHOLE-BODY MRI SYSTEM. This device is classified as a System, Nuclear Magnetic Resonance Imaging (Class II - Special Controls, product code LNH).
Submitted by Time Medical Limited (Hong Kong, CN). The FDA issued a Cleared decision on July 26, 2011, 113 days after receiving the submission on April 4, 2011.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K110942 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2011 |
| Decision Date | July 26, 2011 |
| Days to Decision | 113 days |
| Submission Type | Abbreviated |
| 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 |