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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 / September 2025 / K251002

510(k) cleared

Videa Dental AI

Videahealth, Inc. · Sep 19, 2025 · K251002

FDA cleared the Videa Dental AI from Videahealth, Inc. on Sep 19, 2025 under K251002, a traditional 510(k). The device falls under product code MYN, Analyzer, Medical Image, regulated at 21 CFR 892.2070 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 1, 2025. The decision came 171 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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

Questions & Answers

What did FDA clear under K251002?

K251002 is the FDA 510(k) for Videa Dental AI, submitted by Videahealth, Inc.. FDA's decision date was Sep 19, 2025, under product code MYN (Analyzer, Medical Image).

Who makes the Videa Dental AI?

Videahealth, Inc., based in Boston, MA, is the applicant of record for K251002.

How long did the K251002 review take?

FDA received the submission on Apr 1, 2025 and issued its decision on Sep 19, 2025, 171 days later.

← All decisions in September 2025