TARGET3D FUSION— 510(k) K140033

Substantially Equivalent

Convergent Life Sciences, Inc.

FDA 510(k) clearance K140033 for TARGET3D FUSION, Substantially Equivalent on 2014-02-27. Applicant: Convergent Life Sciences, Inc..

Clearance details

Applicant: Convergent Life Sciences, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2014-01-07
Decision date: 2014-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gold River, CA, US

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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.