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FDA 510(k)

GT300; GT300-C

K-Number: K250060 · 2025-10-08

ApplicantGenoray Co., Ltd.
Decision Date2025-10-08
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GT300; GT300-C is the device name listed in this FDA 510(k) record. The listed applicant is Genoray Co., Ltd.. It received FDA 510(k) clearance on 2025-10-08 under 510(k) number K250060. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GT300; GT300-C?

GT300; GT300-C is a medical device that received FDA 510(k) clearance on 2025-10-08. The listed applicant is Genoray Co., Ltd.. The 510(k) number is K250060.

When did GT300; GT300-C receive FDA 510(k) clearance?

GT300; GT300-C received FDA 510(k) clearance on 2025-10-08, under 510(k) number K250060.

Who is the listed applicant for GT300; GT300-C?

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

What is the FDA product code for GT300; GT300-C?

The FDA product code for GT300; GT300-C is OAS.

Other records listing Genoray Co., Ltd. as applicant

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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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