Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K132475
FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM · Fluoptics · decided 2014-05-07 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| PHOTONVUE OPTICAL HEAD | PVUECOH-1.0 | FLUOPTICS | OWN | B475PVUECOH100 |
| FLUOBEAM SYSTEM STORED INTO FLUOBOX | FX-CL v1.1 | FLUOPTICS | OWN | B475FXCLV111 |
| FLUOBEAM 800 | FB800-CL v1.9 | FLUOPTICS | OWN | B475FB800CLV190 |
| PHOTONVUE | PVUEC0A2 V1.0 | FLUOPTICS | OWN | B475PVUEC0A2V100 |
| Photonvue box | PVUE-TSC-1.0 | FLUOPTICS | OWN | B475PVUETSC101 |
| FLUOBEAM 800 | FB800-CL v1.8 | FLUOPTICS | OWN | B475FB800CLV180 |
| FLUOCASE 800 | FC800-CL v1.9 | FLUOPTICS | OWN | B475FC800CLV190 |
| PHOTONVUE CONTROL BOX | PVUECCB-1.0 | FLUOPTICS | OWN | B475PVUECCB100 |
| FLUOCASE 800 | FC800-CL v1.8 | FLUOPTICS | OWN | B475FC800CLV180 |
| PHOTONVUE | PVUEC0A1 V1.0 | FLUOPTICS | OWN | B475PVUEC0A1V100 |