UROSTATION 3D PROSTATE SUITE— 510(k) K100793

Substantially Equivalent

Koelis

FDA 510(k) clearance K100793 for UROSTATION 3D PROSTATE SUITE, Substantially Equivalent on 2010-09-22. Applicant: Koelis.

Clearance details

Applicant: Koelis
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2010-03-22
Decision date: 2010-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Tronche, FR

Download summary PDF View on FDA.gov ↗

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.