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510(k) K222864

8MP Color LCD Monitor CL-R813 by Jvckenwood Corporation — Product Code PGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2022
Date Received
September 22, 2022
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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