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FDA 510(k)

MRIA Radiation Therapy Information System (MRIA)

K-Number: K260733 · 2026-08-26

ApplicantManteia Technologies Co., Ltd.
Decision Date2026-08-26
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MRIA Radiation Therapy Information System (MRIA) is the device name listed in this FDA 510(k) record. The listed applicant is Manteia Technologies Co., Ltd.. It received FDA 510(k) clearance on 2026-08-26 under 510(k) number K260733. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRIA Radiation Therapy Information System (MRIA)?

MRIA Radiation Therapy Information System (MRIA) is a medical device that received FDA 510(k) clearance on 2026-08-26. The listed applicant is Manteia Technologies Co., Ltd.. The 510(k) number is K260733.

When did MRIA Radiation Therapy Information System (MRIA) receive FDA 510(k) clearance?

MRIA Radiation Therapy Information System (MRIA) received FDA 510(k) clearance on 2026-08-26, under 510(k) number K260733.

Who is the listed applicant for MRIA Radiation Therapy Information System (MRIA)?

The FDA 510(k) record lists Manteia Technologies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MRIA Radiation Therapy Information System (MRIA)?

The FDA product code for MRIA Radiation Therapy Information System (MRIA) is IYE.

Other records listing Manteia Technologies Co., Ltd. as applicant

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Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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