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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / November 2025 / K253303

510(k) cleared

Dendrite Imaging System

Dendrite Imaging, Inc. · Nov 28, 2025 · K253303

FDA cleared the Dendrite Imaging System from Dendrite Imaging, Inc. on Nov 28, 2025 under K253303, a traditional 510(k). The device falls under product code QDG, Parathyroid Autofluorescence Imaging Device, regulated at 21 CFR 878.4550 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 29, 2025. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Dendrite Imaging, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253303?

K253303 is the FDA 510(k) for Dendrite Imaging System, submitted by Dendrite Imaging, Inc.. FDA's decision date was Nov 28, 2025, under product code QDG (Parathyroid Autofluorescence Imaging Device).

Who makes the Dendrite Imaging System?

Dendrite Imaging, Inc., based in Berkeley, CA, is the applicant of record for K253303.

How long did the K253303 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Nov 28, 2025, 60 days later.

← All decisions in November 2025