The AIO Solution— 510(k) K191158

Substantially Equivalent

Orfit Industries NV

FDA 510(k) clearance K191158 for The AIO Solution, Substantially Equivalent on 2019-08-06. Applicant: Orfit Industries NV.

Clearance details

Applicant: Orfit Industries NV
Product code: Code IYE
Advisory panel: Radiology
Date received: 2019-05-01
Decision date: 2019-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wijnegem, BE

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.