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510(k) K200161

3MP Monochrome Digital Mammography LCD Monitor MS-S300 by Jvckenwood Corporation — Product Code PGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2020
Date Received
January 22, 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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  • K191137 — 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 (July 2, 2019)
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  • K173434 — 2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300 (December 14, 2017)
  • K161895 — 2MP Color LCD Monitor CCL214 (CL21214) (September 8, 2016)
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