# K261865: AerFrame™ Alignment Laser Box (LBV2)

- Pathway: 510(k) (Traditional)
- Applicant: Stabilix, LLC
- Decided: Sep 16, 2026 after 104 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: 3 generations back to K935300 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970291: Accessories to the Stereotactic Body Fram, Elekta Instrument AB (1997) Summary page 5.

## Indications for use
Indications for Use (AerFrame™ Alignment Laser Box) The AerFrame™ Alignment Laser Box is indicated for use as an accessory to the AerFrame™ Patient Immobilization System to aid in patient positioning and alignment during photon-based radiotherapy setup. The Alignment Laser Box mounts to the AerFrame™ Coordinate Arch and projects visible laser reference points intended to align with marks on the patient’s skin. The device is intended for use in professional healthcare facilities by trained clinical staff. The device is used only during treatment setup while the linear accelerator is in standby mode. Final patient alignment must be independently verified using image-guided radiotherapy (IGRT) prior to treatment delivery. Intended Patient Population / Selection Criteria: The AerFrame™ Alignment Laser Box is indicated for patients undergoing photon-based radiotherapy setup with the AerFrame™ Patient Immobilization System when supplemental visible laser reference points are used to support patient positioning and alignment. The device is intended only for use with the AerFrame™ Coordinate Arch and is not indicated for standalone use or for use with other immobilization or alignment systems. Contraindications / Limitations: The AerFrame™ Alignment Laser Box is not indicated for use as the sole method of final patient alignment. The device must not be used during treatment beam delivery or gantry movement and must be removed from the AerFrame assembly and treatment area before linear accelerator beam activation or gantry rotation. Final patient alignment must be performed using IGRT.

Source page: https://510kreport.com/device/K261865
Methodology: https://510kreport.com/methodology