Biopsy Positioner
510(k) K191495
Biopsy Positioner is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K191495 on 3 Jul 2019, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK191495 | Date3 Jul 2019 | StatusActive |
Official records
- FDA 510(k) database K191495
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IZH
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1710
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K191495
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| FDR-2000BPY POSITIONER KIT BPSY HA USA E | POSITIONER KIT BPSY HA USA E | 04547410327342 | — | On the market |
| FDR-2000BPY POSITIONER KIT BPY-L HA USA E | POSITIONER KIT BPY-L HA USA E | 04547410336047 | — | On the market |
Similar devices
Other devices filed under FDA product code IZH (System, X-Ray, Mammographic).
- Comfort Cover by PRECISION DYNAMICS CORPORATION
- Lorad M-III Mammographic X-Ray System by Lorad Corp.
- System, X-Ray, Mammographic by Technowipe
- BENNETT X-RAY DIGITAL SPOT IMAGER by Bennett X-Ray Technologies
- AMI MAMMOSPOT by American Mammographics, Inc.
- Affirm Contrast Biopsy by Hologic, Inc.
- Remote Hand Control To The Inflatable Positioning Cushion (A.K.A. Imageair) by Kci New Technologies, Inc.
- Planmed Sophie, Planmed Sophie Classic by Planmed Oy
- Alpha Stereo by Instrumentarium Corp.
- Mammoscan by Fischer Imaging Corp.