DIRECT DIGITIZER, REGIUS MODEL 190— 510(k) K042386

Name: FDA 510(k) clearance K042386
Creator: U.S. Food and Drug Administration
Published: 2004-12-15

Substantially Equivalent

Konica Minolta Medical & Graphic, Inc.

FDA 510(k) clearance K042386 for DIRECT DIGITIZER, REGIUS MODEL 190, Substantially Equivalent on 2004-12-15. 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: 2004-09-02
Decision date: 2004-12-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Watarai-Gun; Mie-Ken, JP

Download summary PDF View on FDA.gov ↗

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