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 / January 2026 / K251351

510(k) cleared

AccuContour 4.0

Manteia Technologies Co., Ltd. · Jan 23, 2026 · K251351

FDA cleared the AccuContour 4.0 from Manteia Technologies Co., Ltd. on Jan 23, 2026 under K251351, 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 Apr 30, 2025. The decision came 268 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: K250780 (ARTAssistant), K250696 (AccuCheck).

Questions & Answers

What did FDA clear under K251351?

K251351 is the FDA 510(k) for AccuContour 4.0, submitted by Manteia Technologies Co., Ltd.. FDA's decision date was Jan 23, 2026, under product code QKB (Radiological Image Processing Software For Radiation Therapy).

Who makes the AccuContour 4.0?

Manteia Technologies Co., Ltd., based in Xiamen, is the applicant of record for K251351.

How long did the K251351 review take?

FDA received the submission on Apr 30, 2025 and issued its decision on Jan 23, 2026, 268 days later.

← All decisions in January 2026

Sources