RadiForce GX560, GX560-AR
K-Number: K181609 · 2018-08-24
ApplicantEizo Corporation
Decision Date2018-08-24
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
RadiForce GX560, GX560-AR is a medical device manufactured by Eizo Corporation. It received FDA 510(k) clearance on 2018-08-24 under approval number K181609. 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 GX560, GX560-AR?
RadiForce GX560, GX560-AR is a medical device that received FDA 510(k) clearance on 2018-08-24. It is manufactured by Eizo Corporation. The 510(k) number is K181609.
When was RadiForce GX560, GX560-AR approved by the FDA?
RadiForce GX560, GX560-AR received FDA 510(k) clearance on 2018-08-24, under approval number K181609.
What company makes RadiForce GX560, GX560-AR?
RadiForce GX560, GX560-AR is manufactured by Eizo Corporation.
What is the FDA product code for RadiForce GX560, GX560-AR?
The FDA product code for RadiForce GX560, GX560-AR is PGY.
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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.