CODIAGNOSTIX (R) 5.72— 510(k) K071636

Substantially Equivalent

Ivs Solutions AG

FDA 510(k) clearance K071636 for CODIAGNOSTIX (R) 5.72, Substantially Equivalent on 2007-08-09. Applicant: Ivs Solutions AG.

Clearance details

Applicant: Ivs Solutions AG
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2007-06-15
Decision date: 2007-08-09
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Chemnitz, Saxony, DE

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.