Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record P160031
Device name not on record · Fujifilm Medical Systems U.S.A, Inc. · decided 2017-01-10 (APPR)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ASPIRE Cristalle Digital Breast Tomosynthesis Option | DR 3500 TOMO KIT V2.0 USA E | FUJIFILM CORPORATION | OTE | 04547410351316 |