KONICA DIRECT DIGITIZER REGIUS, MODEL 170— 510(k) K023061

Name: FDA 510(k) clearance K023061
Creator: U.S. Food and Drug Administration
Published: 2002-10-11

Substantially Equivalent

Konica Minolta Medical & Graphic, Inc.

FDA 510(k) clearance K023061 for KONICA DIRECT DIGITIZER REGIUS, MODEL 170, Substantially Equivalent on 2002-10-11. 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: 2002-09-16
Decision date: 2002-10-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Hachioji-Shi Tokyo, JP

Download summary PDF View on FDA.gov ↗

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