TRINITY/3D PROSTATE SUITE— 510(k) K170521

Substantially Equivalent

Koelis

FDA 510(k) clearance K170521 for TRINITY/3D PROSTATE SUITE, Substantially Equivalent on 2017-05-30. Applicant: Koelis.

Clearance details

Applicant: Koelis
Product code: Code IYN
Advisory panel: Radiology
Date received: 2017-02-22
Decision date: 2017-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Meylan, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYN

product code IYN

Death: 25
Injury: 163
Malfunction: 1,538
Other: 4
Total: 1,730

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.