510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QDGClass II

Parathyroid Autofluorescence Imaging Device

21 CFR 878.4550 / General, Plastic Surgery
FDA source (opens on fda.gov)

QDG is the FDA product code for Parathyroid Autofluorescence Imaging Device, a class II device type, regulated under 21 CFR 878.4550. FDA's definition for this code reads: "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". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QDG
Device name
Parathyroid Autofluorescence Imaging Device
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.
Regulation
21 CFR 878.4550
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code QDG

By decision year
6 clearances under product code QDG with a decision year between 2018 and 2025, 2023 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QDG by decision year
YearClearances
20181
20191
20232
20252

Applicants with the most clearances

Product code QDG
Applicants holding the most 510(k) clearances under product code QDG
ApplicantClearances
Fluoptics2
Fluoptics SAS (A Getinge Group Company)2
Dendrite Imaging, Inc.1
Fluoptics SAS1

Companies listing this code with FDA

Companies whose registered establishments list this code