AerFrame Patient Immobilization System (AFPIS)— 510(k) K260792
Substantially EquivalentStabilix, LLC
FDA 510(k) clearance K260792 for AerFrame Patient Immobilization System (AFPIS), Substantially Equivalent on 2026-05-08. Applicant: Stabilix, LLC. Device class: 2.
Summary
Stabilix filed the AerFrame Patient Immobilization System (AFPIS) under IYE, medical linear accelerators.
Class II, 21 CFR 892.5050. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Stabilix filed from Dallas, Texas. The decision came 58 calendar days after receipt (March 11 to May 8, 2026).
Clearance details
- Applicant
- Stabilix, LLC
- Product code
- Product code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dallas, TX, US
Recent devices under product code IYE
view allAdverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
Source: openFDA MAUDE database, through . 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.