The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Trident Specimen Radiography System, Model : Rc Tri-00001.
| Device ID | K111508 |
| 510k Number | K111508 |
| Device Name: | TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001 |
| Classification | Cabinet, X-ray System |
| Applicant | HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730 |
| Contact | Deborah Thomas |
| Correspondent | Deborah Thomas HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730 |
| Product Code | MWP |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-01 |
| Decision Date | 2011-08-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045505919 | K111508 | 000 |
| 15420045505902 | K111508 | 000 |
| 15420045505841 | K111508 | 000 |