Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K180233
Eviva Stereotactic Guided Breast Biopsy System · Hologic, Inc. · decided 2018-04-10 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| EVIVA_0910-12T | EVIVA_0910-12T | Hologic, Inc. | KNW | 15420045504943 |
| EVIVA_1213-20 | EVIVA_1213-20 | Hologic, Inc. | KNW | 15420045504998 |
| EVIVA 0913-12T | EVIVA 0913-12T | Hologic, Inc. | KNW | 15420045505339 |
| EVIVA 0913-12 | EVIVA 0913-12 | Hologic, Inc. | KNW | 15420045505322 |
| EVIVA_0913-20 | EVIVA_0913-20 | Hologic, Inc. | KNW | 15420045504974 |
| EVIVA_1210-20 | EVIVA_1210-20 | Hologic, Inc. | KNW | 15420045504981 |
| EVIVA_0910-20 | EVIVA_0910-20 | Hologic, Inc. | KNW | 15420045504950 |
| EVIVA_0910-12 | EVIVA_0910-12 | Hologic, Inc. | KNW | 15420045504936 |