Iris AirShuttle— 510(k) K230312

Substantially Equivalent

Qfix

FDA 510(k) clearance K230312 for Iris AirShuttle, Substantially Equivalent on 2023-03-31. Applicant: Qfix.

Clearance details

Applicant: Qfix
Product code: Code IYE
Advisory panel: Radiology
Date received: 2023-02-03
Decision date: 2023-03-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Avondale, PA, US

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.