# K112460: Multiple

- Pathway: 510(k) (Traditional)
- Applicant: Larson Medical Products, Inc.
- Decided: Oct 7, 2011 after 42 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic or hospital setting. In particular, these items provide the stable positioning of patients in various positions, chosen to facilitate accurate treatment of tumors. Patients are those that have been diagnosed and are undergoing treatment for cancerous tumors. Treatment is supervised and administered by licensed doctors and therapists trained in the application of radiation therapy treatments.

Source page: https://510kreport.com/device/K112460
Methodology: https://510kreport.com/methodology