K053046 is an FDA 510(k) clearance for the ILUMA ORTHOCAT/DENTALCAT. This device is classified as a System, X-ray, Tomography, Computed (Class II - Special Controls, product code JAK).
Submitted by Imtec Corp. (Ardmore, US). The FDA issued a Cleared decision on November 8, 2005, 11 days after receiving the submission on October 28, 2005.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1750.
| 510(k) Number | K053046 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2005 |
| Decision Date | November 08, 2005 |
| Days to Decision | 11 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | JAK — System, X-ray, Tomography, Computed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1750 |