KONICA DIRECT DIGITIZER KD-1000— 510(k) K920558

Name: FDA 510(k) clearance K920558
Creator: U.S. Food and Drug Administration
Published: 1992-03-06

Substantially Equivalent

Konica Corp.

FDA 510(k) clearance K920558 for KONICA DIRECT DIGITIZER KD-1000, Substantially Equivalent on 1992-03-06. Applicant: Konica Corp.. Device class: 2.

Clearance details

Applicant: Konica Corp.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 1991-12-13
Decision date: 1992-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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K980873 — KONICA DIRECT DIGITIZER REGIUS MODEL 3301998-06-19
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Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.