QDG

Parathyroid Autofluorescence Imaging Device

Product code
QDG
Device name
Parathyroid Autofluorescence Imaging Device
Device class
Class 2
21 CFR
21 CFR 878.4550
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
510(k) clearances (last 3 years)
6

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2025-11-28.

NumberDecision dateApplicantDevice nameSummary
K2533032025-11-28Dendrite Imaging, Inc.Dendrite Imaging SystemPDF
K2504552025-04-17Fluoptics Sas (A Getinge Group CompanyFLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM ImagiPDF
K2335642023-12-15Fluoptics Sas (A Getinge Group CompanyFLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX RePDF

3 summaries are archived here for direct download.

Official FDA classification page: QDG
Classification and pathway per current FDA publications. Data from openFDA (CC0).