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THE TAPE

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 / April 2026 / K253930

510(k) cleared

Overjet Iris Intelligent Imaging System

Overjet, Inc. · Apr 10, 2026 · K253930

FDA cleared the Overjet Iris Intelligent Imaging System from Overjet, Inc. on Apr 10, 2026 under K253930, 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 Dec 9, 2025. The decision came 122 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), K251514 (Overjet CBCT Assist).

Questions & Answers

What did FDA clear under K253930?

K253930 is the FDA 510(k) for Overjet Iris Intelligent Imaging System, submitted by Overjet, Inc.. FDA's decision date was Apr 10, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Overjet Iris Intelligent Imaging System?

Overjet, Inc., based in Boston, MA, is the applicant of record for K253930.

How long did the K253930 review take?

FDA received the submission on Dec 9, 2025 and issued its decision on Apr 10, 2026, 122 days later.

← All decisions in April 2026

Sources