# K253303: Dendrite Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Dendrite Imaging, Inc.
- Decided: Nov 28, 2025 after 60 days
- Product code: QDG (Parathyroid Autofluorescence Imaging Device)
- Device class: 2
- Regulation: 21 CFR 878.4550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K190891 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190891: Fluobeam LX, Fluoptics (2019) Summary page 5.

## Indications for use
The Dendrite Imaging System is indicated for use in real-time capturing and viewing of autofluorescent images of nerves and can be used as an adjunctive method to assist in the location of nerves during surgery. Use of the device is intended to assist, not replace, experienced visual assessment. The system is not to be used to confirm the absence of nerve tissue and is only to be used to assist in locating visually identified nerves.

Source page: https://510kreport.com/device/K253303
Methodology: https://510kreport.com/methodology