Product code QDG— General, Plastic Surgery
Dendrite Imaging System
- Classification name
- Parathyroid Autofluorescence Imaging Device
- Device class
- Class 2
- Regulation
- 21 CFR 878.4550
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 6
- First cleared
- Most recent
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.”
Market context for product code QDG
FDA has cleared devices under product code QDG between 2018 and 2025, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2025
- 2023
- 2019
- 2018
Top applicants under product code QDG
Recent clearances under product code QDG
- K253303 — Dendrite Imaging System
- K250455 — FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)
- K233564 — FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)
- K230898 — FLUOBEAM® LX Red
- K190891 — Fluobeam LX
- DEN170092 — Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System
Data sourced from openFDA. This site is unofficial and independent of the FDA.