4D SONO-SCAN 1.0— 510(k) K110595

Substantially Equivalent

Tomtec Imaging Systems GmbH

FDA 510(k) clearance K110595 for 4D SONO-SCAN 1.0, Substantially Equivalent on 2011-04-07. Applicant: Tomtec Imaging Systems GmbH.

Clearance details

Applicant: Tomtec Imaging Systems GmbH
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2011-03-02
Decision date: 2011-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Unterschleissheim, 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.