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FDA 510(k)

5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR

K-Number: K162497 · 2016-09-19

ApplicantEizo Corporation
Decision Date2016-09-19
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR is a medical device manufactured by Eizo Corporation. It received FDA 510(k) clearance on 2016-09-19 under approval number K162497. 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 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR?

5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR is a medical device that received FDA 510(k) clearance on 2016-09-19. It is manufactured by Eizo Corporation. The 510(k) number is K162497.

When was 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR approved by the FDA?

5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR received FDA 510(k) clearance on 2016-09-19, under approval number K162497.

What company makes 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR?

5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR is manufactured by Eizo Corporation.

What is the FDA product code for 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR?

The FDA product code for 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR is PGY.

Other Devices by Eizo Corporation

K1633356MP Color LCD Monitor, RadiForce RX660, RX660-AR K1602472MP Color LCD Monitor, RadiForce RX250 and RX250-AR K1533543MP Color LCD Monitor, RadiForce RX350 K172738RadiForce RX560, RX560-AR K170949RadiForce MX315W K182591RadiForce RX360, RX360-AR

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Related Devices (Code: PGY)

K1633356MP Color LCD Monitor, RadiForce RX660, RX660-AREizo Corporation K1625278MP Color LCD Monitor (C81W+)Shenzhen Beacon Display Technology Co., Ltd. K1618952MP Color LCD Monitor CCL214 (CL21214)Jvckenwood Corporation K162196Dell UP3216Q with QUBYX PerfectLum bundleQubyx Software Technologies, Inc. K161229Mammo Tomosynthesis (MDMG-5221)Barco N.V. K161057Diagnostic Imaging Color LCD MonitorNec Display Solutions , 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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