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The Tracker / August 2026 / K260733

510(k) cleared

MRIA Radiation Therapy Information System (MRIA)

Manteia Technologies Co., Ltd. · Aug 26, 2026 · K260733

FDA cleared the MRIA Radiation Therapy Information System (MRIA) from Manteia Technologies Co., Ltd. on Aug 26, 2026 under K260733, a traditional 510(k). The device falls under product code IYE, Accelerator, Linear, Medical, regulated at 21 CFR 892.5050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 6, 2026. The decision came 173 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Manteia Technologies Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K251351 (AccuContour 4.0), K250780 (ARTAssistant), K250696 (AccuCheck).

Questions & Answers

What did FDA clear under K260733?

K260733 is the FDA 510(k) for MRIA Radiation Therapy Information System (MRIA), submitted by Manteia Technologies Co., Ltd.. FDA's decision date was Aug 26, 2026, under product code IYE (Accelerator, Linear, Medical).

Who makes the MRIA Radiation Therapy Information System (MRIA)?

Manteia Technologies Co., Ltd., based in Xiamen, is the applicant of record for K260733.

How long did the K260733 review take?

FDA received the submission on Mar 6, 2026 and issued its decision on Aug 26, 2026, 173 days later.

← All decisions in August 2026

Sources