The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Trident Hd Specimen Radiography System.
| Device ID | K182727 |
| 510k Number | K182727 |
| Device Name: | Trident HD Specimen Radiography System |
| Classification | Cabinet, X-ray System |
| Applicant | Hologic, Inc. 36 Apple Ridge Road Danbury, CT 06810 |
| Contact | Meghan Wakeford |
| Correspondent | Meghan Wakeford Hologic, Inc. 36 Apple Ridge Road Danbury, CT 06810 |
| Product Code | MWP |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-28 |
| Decision Date | 2019-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045512214 | K182727 | 000 |
| 15420045510425 | K182727 | 000 |