JUSHA-M52C Medical Display

FDA 510(k) K150746 · Nanjing Jusha Display Technology Co., Ltd.

Substantially Equivalent

510(k) numberK150746

Submission

Device name
JUSHA-M52C Medical Display
Applicant
Nanjing Jusha Display Technology Co., Ltd.
Mansion, Nanjing, CN
Received
March 23, 2015
Decision date
April 14, 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

510(k)DeviceDecision
K230728JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD MonitorPGY · Traditional 06/09/2023SE
K231170C350/C350G LCD Monitor; M550/M550G LCD MonitorPGY · Traditional 06/07/2023SE
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
K183496JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD MonitorPGY · Traditional 04/08/2019SE

Questions and answers

When was JUSHA-M52C Medical Display cleared by the FDA?

JUSHA-M52C Medical Display (K150746) received a 510(k) decision of Substantially Equivalent on April 14, 2015, 22 days after the submission was received.

What is the product code of K150746?

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