The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Biopsy Positioner.
| Device ID | K191495 |
| 510k Number | K191495 |
| Device Name: | Biopsy Positioner |
| Classification | System, X-ray, Mammographic |
| Applicant | FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun, JP |
| Contact | Randy Vader |
| Correspondent | Jeffrey Wan FUJIFILM Medical Systems U.S.A., Inc. 81 Hartwell AVenue, Suite 300 Lexington, MD 02421 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-05 |
| Decision Date | 2019-07-03 |