K111508 is an FDA 510(k) clearance for the TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001. This device is classified as a Cabinet, X-ray System (Class II - Special Controls, product code MWP).
Submitted by Hologic, Inc. (Bedford, US). The FDA issued a Cleared decision on August 19, 2011, 79 days after receiving the submission on June 1, 2011.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K111508 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2011 |
| Decision Date | August 19, 2011 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MWP — Cabinet, X-ray System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |