SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN— 510(k) K020561

Substantially Equivalent

Tomtec Imaging Systems GmbH

FDA 510(k) clearance K020561 for SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN, Substantially Equivalent on 2002-05-09. Applicant: Tomtec Imaging Systems GmbH.

Clearance details

Applicant: Tomtec Imaging Systems GmbH
Product code: Code IYO
Advisory panel: Radiology
Date received: 2002-02-20
Decision date: 2002-05-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Unterschleissheim, DE

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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.