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510(k) K253303

Dendrite Imaging System by Dendrite Imaging, Inc. — Product Code QDG

K253303 is an FDA 510(k) premarket notification submitted by Dendrite Imaging, Inc. for the device "Dendrite Imaging System". The FDA issued a decision of Substantially Equivalent on Nov 28, 2025. The device falls under product code QDG (Parathyroid Autofluorescence Imaging Device), a Class II device regulated under 21 CFR 878.4550.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 28, 2025
Date Received
Sep 29, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Parathyroid Autofluorescence Imaging Device
Device Class
Class II
Regulation Number
878.4550
Review Panel
SU
Submission Type

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.

Other clearances for product code QDG

  • K250455 — FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) (Apr 17, 2025)
  • K233564 — FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) (Dec 15, 2023)
  • K230898 — FLUOBEAM® LX Red (Jul 28, 2023)
  • K190891 — Fluobeam LX (Jul 31, 2019)
  • DEN170092 — Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System (Nov 2, 2018)

FDA data resources