FLOUROSCOPE, MOBILE C-ARM IMAGE INTENS.— 510(k) K760429

Name: FDA 510(k) clearance K760429
Creator: U.S. Food and Drug Administration
Published: 1976-08-23

Substantially Equivalent

Varian Assoc., Inc.

FDA 510(k) clearance K760429 for FLOUROSCOPE, MOBILE C-ARM IMAGE INTENS., Substantially Equivalent on 1976-08-23. Applicant: Varian Assoc., Inc.. Device class: 2.

Clearance details

Applicant: Varian Assoc., Inc.
Product code: Code OXO
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 1976-08-13
Decision date: 1976-08-23
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 OXO

product code OXO

Death: 6
Injury: 163
Malfunction: 2,099
Other: 1
Total: 2,269

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.