AerFrame Patient Immobilization System (AFPIS)— 510(k) K260792

Substantially Equivalent

Stabilix, LLC

FDA 510(k) clearance K260792 for AerFrame Patient Immobilization System (AFPIS), Substantially Equivalent on 2026-05-08. Applicant: Stabilix, LLC.

Clearance details

Applicant: Stabilix, LLC
Product code: Code IYE
Advisory panel: Radiology
Date received: 2026-03-11
Decision date: 2026-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, 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.