QDG — Parathyroid Autofluorescence Imaging Device Class II
FDA product code QDG covers "Parathyroid Autofluorescence Imaging Device", a Class II medical device regulated under 21 CFR 878.4550. Submissions are reviewed by the General, Plastic Surgery panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QDG
- Device Class
- Class II
- Regulation Number
- 878.4550
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253303 | Dendrite Imaging | Dendrite Imaging System | Nov 28, 2025 |
| K250455 | Fluoptics Sas (A Getinge Group Company} | FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) | Apr 17, 2025 |
| K233564 | Fluoptics Sas (A Getinge Group Company) | FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) | Dec 15, 2023 |
| K230898 | Fluoptics | FLUOBEAM® LX Red | Jul 28, 2023 |
| K190891 | Fluoptics | Fluobeam LX | Jul 31, 2019 |
| DEN170092 | Fluoptics | Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System | Nov 2, 2018 |