GENERAL ELECTRIC RADVIEW MARK I SYSTEM— 510(k) K800564

Name: FDA 510(k) clearance K800564
Creator: U.S. Food and Drug Administration
Published: 1980-05-02

Substantially Equivalent

General Electric Co.

FDA 510(k) clearance K800564 for GENERAL ELECTRIC RADVIEW MARK I SYSTEM, Substantially Equivalent on 1980-05-02. Applicant: General Electric Co.. Device class: 2.

Clearance details

Applicant: General Electric Co.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 1980-03-13
Decision date: 1980-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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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.