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FDA 510(k)

RadiForce GX570; RadiForce GX570-AR

K-Number: K252030 · 2025-08-28

Decision Date2025-08-28
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RadiForce GX570; RadiForce GX570-AR is a medical device manufactured by Eizo Corporation. It received FDA 510(k) clearance on 2025-08-28 under approval number K252030. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RadiForce GX570; RadiForce GX570-AR?

RadiForce GX570; RadiForce GX570-AR is a medical device that received FDA 510(k) clearance on 2025-08-28. It is manufactured by Eizo Corporation. The 510(k) number is K252030.

When was RadiForce GX570; RadiForce GX570-AR approved by the FDA?

RadiForce GX570; RadiForce GX570-AR received FDA 510(k) clearance on 2025-08-28, under approval number K252030.

What company makes RadiForce GX570; RadiForce GX570-AR?

RadiForce GX570; RadiForce GX570-AR is manufactured by Eizo Corporation.

What is the FDA product code for RadiForce GX570; RadiForce GX570-AR?

The FDA product code for RadiForce GX570; RadiForce GX570-AR is PGY.

Other Devices by Eizo Corporation

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Related Devices (Code: PGY)

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.