The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Insight - Fd Mini C-arm Fluoroscopic Imaging System.
| Device ID | K120388 |
| 510k Number | K120388 |
| Device Name: | INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730 |
| Contact | Eileen M Boyle |
| Correspondent | Eileen M Boyle HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-07 |
| Decision Date | 2012-04-06 |
| Summary: | summary |