FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AerFrame Patient Immobilization System (AFPIS)
K Number: K260792
·
Decision May 8, 2026
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
1
Review Days
58
Basic Information
- Device Name
- AerFrame Patient Immobilization System (AFPIS)
- K Number
- K260792
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stabilix, LLC
- Date Received
- March 11, 2026
- Decision Date
- May 8, 2026
- Product Code
- IYE
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYE), ordered by most recent decision date.
ThinkQA 3
FDA 510(k)
FDA Class 2
·Radiology
LUNA 3D
FDA 510(k)
FDA Class 2
·Radiology
VERIQA RT EPID 3D
FDA 510(k)
FDA Class 2
·Radiology
ClearCheck (RADCC V2.7)
FDA 510(k)
FDA Class 2
·Radiology
AlignRT Plus (8.0)
FDA 510(k)
FDA Class 2
·Radiology
Halcyon, Ethos Radiotherapy System (5.0)
FDA 510(k)
FDA Class 2
·Radiology