JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor

FDA 510(k) K183496 · Nanjing Jusha Display Technology Co., Ltd.

Substantially Equivalent

510(k) numberK183496

Submission

Device name
JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor
Applicant
Nanjing Jusha Display Technology Co., Ltd.
Nanjing, CN
Received
December 17, 2018
Decision date
April 8, 2019
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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K230723C510G/JUSHA-C510G/C510/JUSHA- C510 LCD MonitorPGY · Traditional 05/18/2023SE
K230643CP620G LCD monitor, CP620 LCD monitorPGY · Traditional 05/01/2023SE
K222121C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitorPGY · Traditional 09/19/2022SE
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
K190848JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD MonitorPGY · Traditional 05/14/2019SE
K183494R190/R191 LCD MonitorPGY · Traditional 04/05/2019SE

Questions and answers

When was JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor cleared by the FDA?

JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor (K183496) received a 510(k) decision of Substantially Equivalent on April 8, 2019, 112 days after the submission was received.

What is the product code of K183496?

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