The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Fluoroscan Insight Mini C-arm Fluoroscopic Imaging System.
| Device ID | K051025 |
| 510k Number | K051025 |
| Device Name: | FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730 |
| Contact | Daniel F Phelan |
| Correspondent | Daniel F Phelan HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-22 |
| Decision Date | 2005-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045505896 | K051025 | 000 |