K233564
- 510(k) number
- K233564
- Device name
- FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)
- Applicant
- Fluoptics Sas (A Getinge Group Company) FR
- Product code
- QDG — Parathyroid Autofluorescence Imaging Device
- Decision date
- 2023-12-15
- Date received
- 2023-11-06
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K233564.pdf
Official FDA record: K233564
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.