3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION— 510(k) K131448

Substantially Equivalent

Koelis

FDA 510(k) clearance K131448 for 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION, Substantially Equivalent on 2013-07-26. Applicant: Koelis.

Clearance details

Applicant: Koelis
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2013-05-20
Decision date: 2013-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Tronche, FR

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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.