DIRECT DIGITIZER REGIUS MODEL 370— 510(k) K051418

Name: FDA 510(k) clearance K051418
Creator: U.S. Food and Drug Administration
Published: 2005-07-01

Substantially Equivalent

Konica Minolta Medical & Graphic, Inc.

FDA 510(k) clearance K051418 for DIRECT DIGITIZER REGIUS MODEL 370, Substantially Equivalent on 2005-07-01. Applicant: Konica Minolta Medical & Graphic, Inc.. Device class: 2.

Clearance details

Applicant: Konica Minolta Medical & Graphic, Inc.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2005-06-01
Decision date: 2005-07-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Mie-Ken, JP

Download summary PDF View on FDA.gov ↗

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