# QDG: Parathyroid Autofluorescence Imaging Device

- Device class: 2; regulation: 21 CFR 878.4550; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 59 days (middle half 53–75)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2018: 1
- 2019: 1
- 2023: 2
- 2025: 2

## Most-cited predicates
- K190891: Fluobeam LX (2019), cited by 3
- K233564: FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) (2023), cited by 1
- DEN170092: Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System (2018), cited by 1
- K230898: FLUOBEAM® LX Red (2023), cited by 1

Source page: https://510kreport.com/product-code/QDG
Data by year (CSV): https://510kreport.com/product-code/QDG.csv