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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 the device name listed in this FDA 510(k) record. The listed applicant is Eizo Corporation. It received FDA 510(k) clearance on 2016-09-19 under 510(k) 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. The listed applicant is Eizo Corporation. The 510(k) number is K162497.

When did 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR receive FDA 510(k) clearance?

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

Who is the listed applicant for 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-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 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR?

The FDA product code for 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-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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