JUSHA-C23C LCD Monitor

FDA 510(k) K151861 · Nanjing Jusha Display Technology Co., Ltd.

Substantially Equivalent

510(k) numberK151861

Submission

Device name
JUSHA-C23C LCD Monitor
Applicant
Nanjing Jusha Display Technology Co., Ltd.
Mansion, Nanjing, CN
Received
July 8, 2015
Decision date
September 10, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PGY – Display, Diagnostic Radiology
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.

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More from Eizo Corporation

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K212231C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD MonitorPGY · Traditional 03/25/2022SE
K200742JUSHA-CP610 LCD MonitorPGY · Traditional 07/24/2020SE
K190831E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD…GCJ · Traditional 05/31/2019SE
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Questions and answers

When was JUSHA-C23C LCD Monitor cleared by the FDA?

JUSHA-C23C LCD Monitor (K151861) received a 510(k) decision of Substantially Equivalent on September 10, 2015, 64 days after the submission was received.

What is the product code of K151861?

The FDA product code is PGY – Display, Diagnostic Radiology, a Class II (moderate risk) device regulated under 21 CFR 892.2050.