510(k) K250455
- Device
- FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)
- Applicant
- Fluoptics Sas (A Getinge Group Company}
- 510(k) number
- K250455
- Product code
- QDG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-04-17
- Date received
- 2025-02-18
- Regulation
- 878.4550
- Classification name
- Parathyroid Autofluorescence Imaging Device
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Marion Boudet
- Address
- 44 Rue Des Berges Grenoble FR 38000 38000
FDA Registration Numbers#
- 3011092264
- 2031093
Source Documents#
Other 510(k) Records For Product Code QDG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253303 | Dendrite Imaging System | Dendrite Imaging, Inc. | 2025-11-28 |
| K233564 | FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) | Fluoptics Sas (A Getinge Group Company) | 2023-12-15 |
| K230898 | FLUOBEAM® LX Red | Fluoptics Sas | 2023-07-28 |
| K190891 | Fluobeam LX | Fluoptics | 2019-07-31 |
| DEN170092 | Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System | Fluoptics | 2018-11-02 |