# K973953: Aktina Medical Physics Corporation Eectron Beam Field Shaping System

- Pathway: 510(k) (Traditional)
- Applicant: Aktina Medical Physics Corp.
- Decided: Jan 14, 1998 after 90 days
- Product code: IXI (Block, Beam-Shaping, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5710
- 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 K842615 (1984). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K842615: Clark Precision Block Cutter, Cooling, Clark Research and Development, Inc. (1984) Summary page 1.

## Indications for use
In Radiation Therapy, it is often necessary to create irregularly shaped fields to contour to the desired treatment shape. Irregular shaped fields for electron beam cases can be achieved by supplementing the shaping ability of the treatment machine’s electron collimation system with tertiary beam blocks. These Beam Blocks are inserted into the ends of the electron cones. The electron beam blocks are created from low melting point lead alloy that is poured in a molten state into a pre-cut Styrofoam form. When the molten lead alloy cools it creates a hard, lead shield custom shaped for the desired form.

Source page: https://510kreport.com/device/K973953
Methodology: https://510kreport.com/methodology