3MP Monochrome Digital Mammography LCD Monitor MS-S300— 510(k) K200161

Name: FDA 510(k) clearance K200161
Creator: U.S. Food and Drug Administration
Published: 2020-02-21

Substantially Equivalent

Jvckenwood Corporation

FDA 510(k) clearance K200161 for 3MP Monochrome Digital Mammography LCD Monitor MS-S300, Substantially Equivalent on 2020-02-21. Applicant: Jvckenwood Corporation. Device class: 2.

Clearance details

Applicant: Jvckenwood Corporation
Product code: Code PGY
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2020-01-22
Decision date: 2020-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokohama, JP

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.