510(k) K253303

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

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 28, 2025
Date Received: September 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) (April 17, 2025)
K233564 — FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) (December 15, 2023)
K230898 — FLUOBEAM® LX Red (July 28, 2023)
K190891 — Fluobeam LX (July 31, 2019)
DEN170092 — Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System (November 2, 2018)