# K161984: Interlocked Circular Small Field Collimators, Elekta Integrated

- Pathway: 510(k) (Traditional)
- Applicant: Aktina Medical Corporation
- Decided: Sep 27, 2016 after 70 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 K971893 (1997). 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)
- K123788: Integrated Collimator Verification and Interlock System (Icvi), Varian Medical Systems, Inc. (2013) Summary page 4.

## Indications for use
The Circular Small Field Collimators, Elekta Integrated, are intended for use with the Elekta line of digital medical linear accelerators (LINAC) for the creation of small circular fields. These fields are used for patients who require external beam radiation therapy or stereotactic radiosurgery of the cranial or extra cranial regions for the treatment of tumors or lesions.

Source page: https://510kreport.com/device/K161984
Methodology: https://510kreport.com/methodology