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510(k) K190848

JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor by Nanjing Jusha Display Technology Co., Ltd. — Product Code PGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2019
Date Received
April 1, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Display, Diagnostic Radiology
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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

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