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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Eizo Corporation. It received FDA 510(k) clearance on 2018-08-24 under 510(k) 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. The listed applicant is Eizo Corporation. The 510(k) number is K181609.

When did RadiForce GX560, GX560-AR receive FDA 510(k) clearance?

RadiForce GX560, GX560-AR received FDA 510(k) clearance on 2018-08-24, under 510(k) number K181609.

Who is the listed applicant for RadiForce GX560, GX560-AR?

The FDA 510(k) record lists Eizo Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RadiForce GX560, GX560-AR?

The FDA product code for RadiForce GX560, GX560-AR is PGY.

Other records listing Eizo Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252030RadiForce GX570; RadiForce GX570-ARK242545RadiForce MX317W-PAK243221RadiForce RX570; RadiForce RX570-ARK241441RadiForce RX670; RadiForce RX670-ARK233465RadiForce MX317WK231066CuratOR EX3242-FD

View all 21 devices →

Related Devices (Code: PGY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261213Medical Monitor (40HT513D)Lg Electronics.IncK252780LCD Monitor (CL1902A, CL2103F)Shenzhen Beacon Display Technology Co., Ltd.K253242LCD Monitor (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd.K252030RadiForce GX570; RadiForce GX570-AREizo CorporationK243221RadiForce RX570; RadiForce RX570-AREizo CorporationK243031LCD Monitors C310S, G310S, C316S, G316S, C616WShenzhen Beacon Display Technology Co., Ltd.

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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