12MP Color Digital Mammography LCD Monitor CL-S1200— 510(k) K203733

Name: FDA 510(k) clearance K203733
Creator: U.S. Food and Drug Administration
Published: 2021-06-29

Substantially Equivalent

Jvckenwood Corporation

FDA 510(k) clearance K203733 for 12MP Color Digital Mammography LCD Monitor CL-S1200, Substantially Equivalent on 2021-06-29. 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: 2020-12-21
Decision date: 2021-06-29
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.