K053592 is an FDA 510(k) clearance for the SIMPLANT DR. JAMES. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on February 8, 2006, 47 days after receiving the submission on December 23, 2005.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K053592 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2005 |
| Decision Date | February 08, 2006 |
| Days to Decision | 47 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ — System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |