Panels › General, Plastic Surgery › Product code QDG · Class 2
Parathyroid Autofluorescence Imaging Device
Regulation 878.4550
1510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QDG
| Company | 510(k)s | Recalls |
|---|---|---|
| Fluoptics | 3 | 0 |
| Fluoptics Sas (A Getinge Group Company) | 2 | 0 |
| Dendrite Imaging, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 28, 2025 | K253303 | Dendrite Imaging System Dendrite Imaging, Inc. | QDG |
| Apr 17, 2025 | K250455 | FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) Fluoptics Sas (A Getinge Group Company}, FR | QDG |
| Dec 15, 2023 | K233564 | FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) Fluoptics Sas (A Getinge Group Company), FR | QDG |
| Jul 28, 2023 | K230898 | FLUOBEAM® LX Red Fluoptics Sas, FR | QDG |
| Jul 31, 2019 | K190891 | Fluobeam LX Fluoptics, FR | QDG |
| Nov 2, 2018 | DEN170092 | Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System Fluoptics, FR | QDG |
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