SIRIO H3— 510(k) K163643

Substantially Equivalent

Masmec Spa

FDA 510(k) clearance K163643 for SIRIO H3, Substantially Equivalent on 2017-11-16. Applicant: Masmec Spa.

Clearance details

Applicant: Masmec Spa
Product code: Code JAK
Advisory panel: Radiology
Date received: 2016-12-23
Decision date: 2017-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Modugno (Ba), IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

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.