QDG — Parathyroid Autofluorescence Imaging Device Class II
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 | November 28, 2025 |
| K250455 | fluoptics sas (a getinge group company} | FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) | April 17, 2025 |
| K233564 | fluoptics sas (a getinge group company) | FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) | December 15, 2023 |
| K230898 | fluoptics | FLUOBEAM® LX Red | July 28, 2023 |
| K190891 | fluoptics | Fluobeam LX | July 31, 2019 |
| DEN170092 | fluoptics | Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System | November 2, 2018 |