KONICA DIRECT DIGITIZER REGIUS MODEL 330— 510(k) K980873

Name: FDA 510(k) clearance K980873
Creator: U.S. Food and Drug Administration
Published: 1998-06-19

Substantially Equivalent

Konica Corp.

FDA 510(k) clearance K980873 for KONICA DIRECT DIGITIZER REGIUS MODEL 330, Substantially Equivalent on 1998-06-19. Applicant: Konica Corp.. Device class: 2.

Clearance details

Applicant: Konica Corp.
Product code: Code LMA
Device class: Class 2
Regulation: 21 CFR 892.2030
Advisory panel: Radiology
Date received: 1998-03-06
Decision date: 1998-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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