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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 / August 2026 / K261059

510(k) cleared

Overjet Multi-Image Caries and Charting Assist

Overjet, Inc. · Aug 6, 2026 · K261059

FDA cleared the Overjet Multi-Image Caries and Charting Assist from Overjet, Inc. on Aug 6, 2026 under K261059, 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 Mar 31, 2026. The decision came 128 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Overjet, Inc. has 2 other decisions in the tracker over the last 12 months: K253930 (Overjet Iris Intelligent Imaging System), K251514 (Overjet CBCT Assist).

Questions & Answers

What did FDA clear under K261059?

K261059 is the FDA 510(k) for Overjet Multi-Image Caries and Charting Assist, submitted by Overjet, Inc.. FDA's decision date was Aug 6, 2026, under product code MYN (Analyzer, Medical Image).

Who makes the Overjet Multi-Image Caries and Charting Assist?

Overjet, Inc., based in Boston, MA, is the applicant of record for K261059.

How long did the K261059 review take?

FDA received the submission on Mar 31, 2026 and issued its decision on Aug 6, 2026, 128 days later.

← All decisions in August 2026

Sources