SWEMAC REISON BIPLANAR 300— 510(k) K911739

Name: FDA 510(k) clearance K911739
Creator: U.S. Food and Drug Administration
Published: 1991-10-23

Substantially Equivalent

Seemac Reison AB Co.

FDA 510(k) clearance K911739 for SWEMAC REISON BIPLANAR 300, Substantially Equivalent on 1991-10-23. Applicant: Seemac Reison AB Co.. Device class: 2.

Clearance details

Applicant: Seemac Reison AB Co.
Product code: Code OXO
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 1991-04-17
Decision date: 1991-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sweden, SE

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.