FDA product code QDG: Parathyroid Autofluorescence Imaging Device
QDG is the FDA product code for parathyroid autofluorescence imaging device. It is a Class II device, regulated under 21 CFR 878.4550 and reviewed by the General and Plastic Surgery panel. FDA has cleared 5 510(k) submissions under QDG, 4 in the last five years, from 5 different applicants. The average 510(k) review took 79 days (median 60); 59 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Parathyroid Autofluorescence Imaging Device |
| Device class | Class II |
| Regulation | 21 CFR 878.4550 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for QDG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 117 |
| 2023 | 2 | 79 |
| 2025 | 2 | 59 |
Compare with all 510(k) review times · Search every QDG clearance
Top QDG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dendrite Imaging, Inc. | 1 | 2025-11-28 |
| Fluoptics Sas (A Getinge Group Company} | 1 | 2025-04-17 |
| Fluoptics Sas (A Getinge Group Company) | 1 | 2023-12-15 |
| Fluoptics Sas | 1 | 2023-07-28 |
| Fluoptics | 1 | 2019-07-31 |
Most recent QDG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253303 | Dendrite Imaging, Inc. | Dendrite Imaging System | 2025-11-28 | 60 |
| K250455 | Fluoptics Sas (A Getinge Group Company} | FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) | 2025-04-17 | 58 |
| K233564 | Fluoptics Sas (A Getinge Group Company) | FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) | 2023-12-15 | 39 |
| K230898 | Fluoptics Sas | FLUOBEAM® LX Red | 2023-07-28 | 119 |
| K190891 | Fluoptics | Fluobeam LX | 2019-07-31 | 117 |
Recalls for QDG devices
openFDA lists no recalls for product code QDG.
Frequently asked questions
What is FDA product code QDG?
QDG is the FDA product code for parathyroid autofluorescence imaging device. It is a Class II device, regulated under 21 CFR 878.4550 and reviewed by the General and Plastic Surgery panel.
What device class is QDG?
Class II, regulation 21 CFR 878.4550. Typical premarket route: 510(k).
How long does a 510(k) take for product code QDG?
Across 5 cleared submissions the average was 79 days from receipt to decision (median 60).
Which companies have the most QDG clearances?
Dendrite Imaging, Inc. (1); Fluoptics Sas (A Getinge Group Company} (1); Fluoptics Sas (A Getinge Group Company) (1); Fluoptics Sas (1); Fluoptics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QDG
- Run a recall and safety report across every QDG manufacturer
- Watch product code QDG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times