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510(k) K203733

12MP Color Digital Mammography LCD Monitor CL-S1200 by Jvckenwood Corporation — Product Code PGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2021
Date Received
December 21, 2020
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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