The following data is part of a premarket notification filed by Fuji Film Medical Systems with the FDA for Biopsy Positioner.
| Device ID | K113284 |
| 510k Number | K113284 |
| Device Name: | BIOPSY POSITIONER |
| Classification | System, X-ray, Mammographic |
| Applicant | FUJI FILM MEDICAL SYSTEMS 419 WEST AVE. Stamford, CT 06902 |
| Contact | Kimerly A Sharp |
| Correspondent | Kimerly A Sharp FUJI FILM MEDICAL SYSTEMS 419 WEST AVE. Stamford, CT 06902 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-07 |
| Decision Date | 2012-03-07 |
| Summary: | summary |