MODIFICATION TO: RADIANALYZER, MODEL 12711— 510(k) K042628

Substantially Equivalent

Radi Medical Systems AB

FDA 510(k) clearance K042628 for MODIFICATION TO: RADIANALYZER, MODEL 12711, Substantially Equivalent on 2005-01-19. Applicant: Radi Medical Systems AB.

Clearance details

Applicant: Radi Medical Systems AB
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2004-09-27
Decision date: 2005-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uppsala, SE

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Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.