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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 a medical device manufactured by Genoray Co., Ltd.. It received FDA 510(k) clearance on 2025-10-08 under approval 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. It is manufactured by Genoray Co., Ltd.. The 510(k) number is K250060.

When was GT300; GT300-C approved by the FDA?

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

What company makes GT300; GT300-C?

GT300; GT300-C is manufactured by Genoray Co., Ltd..

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

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

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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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