K182727 is an FDA 510(k) clearance for the Trident HD Specimen Radiography System. This device is classified as a Cabinet, X-ray System (Class II - Special Controls, product code MWP).
Submitted by Hologic, Inc. (Danbury, US). The FDA issued a Cleared decision on January 10, 2019, 104 days after receiving the submission on September 28, 2018.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K182727 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2018 |
| Decision Date | January 10, 2019 |
| Days to Decision | 104 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 |