QDG
- Product code
- QDG
- Device name
- Parathyroid Autofluorescence Imaging Device
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4550
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 6
FDA classification definition
An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253303 | 2025-11-28 | Dendrite Imaging, Inc. | Dendrite Imaging System | |
| K250455 | 2025-04-17 | Fluoptics Sas (A Getinge Group Company | FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imagi | |
| K233564 | 2023-12-15 | Fluoptics Sas (A Getinge Group Company | FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Re |
Official FDA classification page: QDG
Classification and pathway per current FDA publications. Data from openFDA (CC0).