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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 / December 2025 / K251514

510(k) cleared

Overjet CBCT Assist

Overjet, Inc. · Dec 5, 2025 · K251514

FDA cleared the Overjet CBCT Assist from Overjet, Inc. on Dec 5, 2025 under K251514, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 16, 2025. The decision came 203 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: K261059 (Overjet Multi-Image Caries and Charting Assist), K253930 (Overjet Iris Intelligent Imaging System).

Questions & Answers

What did FDA clear under K251514?

K251514 is the FDA 510(k) for Overjet CBCT Assist, submitted by Overjet, Inc.. FDA's decision date was Dec 5, 2025, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Overjet CBCT Assist?

Overjet, Inc., based in Boston, MA, is the applicant of record for K251514.

How long did the K251514 review take?

FDA received the submission on May 16, 2025 and issued its decision on Dec 5, 2025, 203 days later.

← All decisions in December 2025

Sources