QDG
6 FDA 510(k) clearances · Product code
117 daysmedian time to decision
315 days90th percentile
6clearances measured
FDA profile
- Official device name
- Parathyroid Autofluorescence Imaging Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4550
- Medical specialty
- General, Plastic Surgery
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| Dendrite Imaging System (K253303) | Dendrite Imaging, Inc. | 2025-11-28 |
| FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) (K250455) | Fluoptics Sas (A Getinge Group Company} | 2025-04-17 |
| FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) (K233564) | Fluoptics Sas (A Getinge Group Company) | 2023-12-15 |
| FLUOBEAM® LX Red (K230898) | Fluoptics Sas | 2023-07-28 |
| Fluobeam LX (K190891) | Fluoptics | 2019-07-31 |
| Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System (DEN170092) | Fluoptics | 2018-11-02 |
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Every clearance here is in the API, with alerts when new ones post.