RADIN, MODEL V 3.0— 510(k) K043483

Substantially Equivalent

Sohard AG

FDA 510(k) clearance K043483 for RADIN, MODEL V 3.0, Substantially Equivalent on 2005-01-28. Applicant: Sohard AG.

Clearance details

Applicant: Sohard AG
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2004-12-17
Decision date: 2005-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fuerth, Bayern, 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.