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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 / March 2026 / K252538

510(k) cleared

CEPHX3D

Orca Dental AI , Ltd. · Mar 5, 2026 · K252538

FDA cleared the CEPHX3D from Orca Dental AI , Ltd. on Mar 5, 2026 under K252538, 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 Aug 12, 2025. The decision came 205 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 Orca Dental AI , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252538?

K252538 is the FDA 510(k) for CEPHX3D, submitted by Orca Dental AI , Ltd.. FDA's decision date was Mar 5, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the CEPHX3D?

Orca Dental AI , Ltd., based in Ra'Anana, is the applicant of record for K252538.

How long did the K252538 review take?

FDA received the submission on Aug 12, 2025 and issued its decision on Mar 5, 2026, 205 days later.

← All decisions in March 2026