# K260792: AerFrame Patient Immobilization System (AFPIS)

- Pathway: 510(k) (Traditional)
- Applicant: Stabilix, LLC
- Decided: May 8, 2026 after 58 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K935300 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960338: Stereotactic Body Frame, Elekta Instrument AB (1996) Summary page 5.

## Indications for use
Indications for Use (AerFrame™ Patient Immobilization System) The AerFrame™ Patient Immobilization System is indicated for use to aid in patient positioning and immobilization during diagnostic imaging procedures (e.g., CT and MRI) and photon-based radiotherapy. When used for radiotherapy, the system is indicated for use only in conjunction with image-guided radiotherapy (IGRT) for final patient alignment. The AerFrame system is intended for use in professional healthcare facilities by trained clinical staff. Intended Patient Population / Selection Criteria: The AerFrame system is indicated for patients who require immobilization to support repeatable positioning during CT/MRI imaging and photon-based radiotherapy workflows and who can be safely accommodated within the AerFrame and the required vacuum bag immobilization system. The system is intended for use with a compatible vacuum bag system and is not indicated for use without a vacuum bag. Maximum patient weight is 300 lb (136 kg). Contraindications / Limitations: No specific contraindications. The AerFrame system is not indicated for patients who exceed the maximum patient weight limit (300 lb / 136 kg) or when use of the required vacuum bag is not possible. When used for radiotherapy, the AerFrame system is not indicated for use as the sole method of final patient alignment; IGRT must be used for final alignment

Source page: https://510kreport.com/device/K260792
Methodology: https://510kreport.com/methodology