FDA Product Code
FDA Product Code QDG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4550
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253303 | Dendrite Imaging System | Dendrite Imaging, Inc. | 2025-11-28 | Traditional | PDF ↗ |
| K250455 | FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) | Fluoptics Sas (A Getinge Group Company} | 2025-04-17 | Traditional | PDF ↗ |
| K233564 | FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) | Fluoptics Sas (A Getinge Group Company) | 2023-12-15 | Special | PDF ↗ |
| K230898 | FLUOBEAM® LX Red | Fluoptics Sas | 2023-07-28 | Special | PDF ↗ |
| K190891 | Fluobeam LX | Fluoptics | 2019-07-31 | Traditional | PDF ↗ |
| DEN170092 | Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System | Fluoptics | 2018-11-02 | Direct | — |
Product code QDG · Class II · General, Plastic Surgery. Data: openFDA.