The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Fs Iv Mini C-arm System.
| Device ID | K974058 |
| 510k Number | K974058 |
| Device Name: | FS IV MINI C-ARM SYSTEM |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | HOLOGIC, INC. 590 LINCOLN ST. Waltham, MA 02154 |
| Contact | Nandini Murthy |
| Correspondent | Nandini Murthy HOLOGIC, INC. 590 LINCOLN ST. Waltham, MA 02154 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-27 |
| Decision Date | 1998-01-12 |
| Summary: | summary |