# K014081: Aktina Medical Physics Radiation Therapy Wedges

- Pathway: 510(k) (Traditional)
- Applicant: Aktina Medical Physics Corp.
- Decided: Mar 5, 2002 after 84 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: 1 generation back to K832503 (1983). 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)
- K862339: Mevatron KD-2, Siemens Medical Laboratories, Inc. (1986) Summary page 1.
- K832503: Clinac 1800, Varian Assoc., Inc. (1983) Summary page 1.

## Indications for use
In radiation therapy, it is often desirable to modify the intensity or penetrating depth of a treatment beam so as to minimize radiation exposure to normal tissue. Many devices have and are used for this function including but not limited to partial beam blocks, tissue compensating filters, the most commonly, the wedge. This physical device is constructed of high-density materials that when machined into a wedge shaped block, differentially attenuate the transmitted radiation beam. The resulting radiation beam that is transmitted through the wedge will have a sloped intensity at the patient surface as compared to an un-attenuated beam, which is uniform and consistent in intensity across the beam at the patient's surface. These wedges are designed for use only as a beam-modifying agent with photon beams in Radiation Therapy external beam treatments.

Source page: https://510kreport.com/device/K014081
Methodology: https://510kreport.com/methodology