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Product codes
QDG
Product code QDG
Device name
Parathyroid Autofluorescence Imaging Device
Medical specialty
General, Plastic Surgery
Device class
2
Regulation number
878.4550
Review panel
SU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.
Source
FDA openFDA device classification dataset
Related 510(k) Records
#
510(k), Device, Applicant table
510(k)
Device
Applicant
Decision date
K253303
Dendrite Imaging System
Dendrite Imaging, Inc.
2025-11-28
K250455
FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)
Fluoptics Sas (A Getinge Group Company}
2025-04-17
K233564
FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)
Fluoptics Sas (A Getinge Group Company)
2023-12-15
K230898
FLUOBEAM® LX Red
Fluoptics Sas
2023-07-28
K190891
Fluobeam LX
Fluoptics
2019-07-31
DEN170092
Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System
Fluoptics
2018-11-02
Related GUDID Devices
#
Primary DI, Brand, Company table
Primary DI
Brand
Company
Published
B475FBLXR0
FLUOBEAM LX Red
FLUOPTICS
2024-05-06
B475FBLX0
FLUOBEAM LX
FLUOPTICS
2019-09-05