K260792
- 510(k) number
- K260792
- Device name
- AerFrame Patient Immobilization System (AFPIS)
- Applicant
- Stabilix, LLC TX · US
- Product code
- IYE — Accelerator, Linear, Medical
- Decision date
- 2026-05-08
- Date received
- 2026-03-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K260792.pdf
Official FDA record: K260792
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.