# K072454: Integra Radionics Interfix Patient Adapters

- Pathway: 510(k) (Traditional)
- Applicant: Integra Radionics, Inc.
- Decided: Oct 16, 2007 after 46 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K912630 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924632: LCM-2-Linac Couch-Mount System, Radionics, Inc. (1993) Summary page 1.
- K912630: Xknife Radiosurgery System, Rsa, Inc. (1991) Summary page 1.

## Recalls of this device
- Jan 23, 2012 · Not classified · Z-1187-2012: Material used in the superior region of the InterFix CT Adapter (CTA) has a different density than that of the Treatment Table Couch Adapter (TTA). Resulting dosimetry can be affected if posterior fie

## Indications for use
For cranial fixation during CT scanning and treatment with the TomoTherapy HiArt System.

Source page: https://510kreport.com/device/K072454
Methodology: https://510kreport.com/methodology