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FDA 510(k)

Diagnostic Imaging Color LCD Monitor

K-Number: K161057 · 2016-05-13

ApplicantNec Display Solutions , Ltd.
Decision Date2016-05-13
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Diagnostic Imaging Color LCD Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Nec Display Solutions , Ltd.. It received FDA 510(k) clearance on 2016-05-13 under 510(k) number K161057. 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 Diagnostic Imaging Color LCD Monitor?

Diagnostic Imaging Color LCD Monitor is a medical device that received FDA 510(k) clearance on 2016-05-13. The listed applicant is Nec Display Solutions , Ltd.. The 510(k) number is K161057.

When did Diagnostic Imaging Color LCD Monitor receive FDA 510(k) clearance?

Diagnostic Imaging Color LCD Monitor received FDA 510(k) clearance on 2016-05-13, under 510(k) number K161057.

Who is the listed applicant for Diagnostic Imaging Color LCD Monitor?

The FDA 510(k) record lists Nec Display Solutions , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diagnostic Imaging Color LCD Monitor?

The FDA product code for Diagnostic Imaging Color LCD Monitor is PGY.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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