K093984 is an FDA 510(k) clearance for the PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01. This device is classified as a System, Nuclear Magnetic Resonance Imaging (Class II - Special Controls, product code LNH).
Submitted by Time Medical Limited (Shanghai, CN). The FDA issued a Cleared decision on March 24, 2010, 90 days after receiving the submission on December 24, 2009.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K093984 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 2009 |
| Decision Date | March 24, 2010 |
| Days to Decision | 90 days |
| Submission Type | Special |
| 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 |