WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

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 / December 2025 / K250780

510(k) cleared

ARTAssistant

Manteia Technologies Co., Ltd. · Dec 5, 2025 · K250780

FDA cleared the ARTAssistant from Manteia Technologies Co., Ltd. on Dec 5, 2025 under K250780, a traditional 510(k). The device falls under product code QKB, Radiological Image Processing Software For Radiation Therapy, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 14, 2025. The decision came 266 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Manteia Technologies Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K251351 (AccuContour 4.0), K250696 (AccuCheck).

Questions & Answers

What did FDA clear under K250780?

K250780 is the FDA 510(k) for ARTAssistant, submitted by Manteia Technologies Co., Ltd.. FDA's decision date was Dec 5, 2025, under product code QKB (Radiological Image Processing Software For Radiation Therapy).

Who makes the ARTAssistant?

Manteia Technologies Co., Ltd., based in Xiamen, is the applicant of record for K250780.

How long did the K250780 review take?

FDA received the submission on Mar 14, 2025 and issued its decision on Dec 5, 2025, 266 days later.

← All decisions in December 2025

Sources