4D MV-ASSESSMENT 2.0— 510(k) K103782

Substantially Equivalent

Tomtec Imaging Systems GmbH

FDA 510(k) clearance K103782 for 4D MV-ASSESSMENT 2.0, Substantially Equivalent on 2011-01-27. Applicant: Tomtec Imaging Systems GmbH.

Clearance details

Applicant: Tomtec Imaging Systems GmbH
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2010-12-27
Decision date: 2011-01-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Unterschleissheim, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.