K191495 is an FDA 510(k) clearance for the Biopsy Positioner. This device is classified as a System, X-ray, Mammographic (Class II - Special Controls, product code IZH).
Submitted by Fujifilm Corporation (Ashigarakami-Gun, JP). The FDA issued a Cleared decision on July 3, 2019, 28 days after receiving the submission on June 5, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1710.
| 510(k) Number | K191495 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 2019 |
| Decision Date | July 03, 2019 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZH — System, X-ray, Mammographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1710 |