# K100096: Linac Collimator Assembly Housing (Lcah) Model Lcahart

- Pathway: 510(k) (Traditional)
- Applicant: Integra Radionics, Inc.
- Decided: Apr 22, 2010 after 99 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: 9 generations back to K914698 (1992). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912630: Xknife Radiosurgery System, Rsa, Inc. (1991) Summary page 1.
- K072485: Artiste MV SA, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.

## Indications for use
The Integra Radian iCSTm Linac Collimator Assembly Housing (LOAHART) is indicated to be mounted on the Siemens Artiste MV linac with MLC-160 Accessory Holder as an Accessory tray to attach Integra Radionics collimators for treatment modalities such as stereotactic radibsurgery (SRS) and radiotherapy (SRT).

Source page: https://510kreport.com/device/K100096
Methodology: https://510kreport.com/methodology