X TWIN SYSTEM— 510(k) K133496

Substantially Equivalent

Roesys GmbH

FDA 510(k) clearance K133496 for X TWIN SYSTEM, Substantially Equivalent on 2014-12-03. Applicant: Roesys GmbH.

Clearance details

Applicant: Roesys GmbH
Product code: Code KPR
Advisory panel: Radiology
Date received: 2013-11-14
Decision date: 2014-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Espelkamp, Nordrhein-Westfalen, DE

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Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.