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510(k) K160326

5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) by Jvckenwood Corporation — Product Code PGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2016
Date Received
February 5, 2016
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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