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GT300 - Gt300

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250060

by Genoray Co., Ltd.

Identifiers

510(k) Number
K250060 FDA 510(k)
FDA Product Code
OAS FDA 510(k)
Models / Variants
Gt300 FDA 510(k)
Gt300-C FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1750 FDA 510(k)
Regulation Number
892.1750 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

GT300 - Gt300 by Genoray Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 2 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Genoray Co., Ltd.

Sources (1)

  • FDA 510(k) K250060 24 fields · synced Jun 18, 2026