# K032248: Precise Carbon Fiber Table Top, Model 11-999

- Pathway: 510(k) (Traditional)
- Applicant: Aktina Medical Physics Corp.
- Decided: Sep 25, 2003 after 65 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 K904005 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983678: Elekta Oncology Systems Precise Treatment Table, Elekta Instruments, Inc. (1999) Summary page 1.
- K991546: Aktina Medical Physics Corporation Tilt Board, Aktina Medical Physics Corp. (1999) Summary page 1.

## Indications for use
External beam radiation therapy is typically delivered from a linear accelerator with either photon or electron beams, or from a radioactive source (high and low dose rate variants) to patients in the prone or supine position, lying on a patient support assembly (also known as the treatment couch). AKTINA Medical Physics Corporation has designed and manufactured a replacement table top of carbon fiber that is compatible with the Elekta Precise Patient Support System. A treatment couch top that is made of carbon fiber provides the structural strength necessary to support a broad range of patients while being light weight. In addition carbon fiber is radiolucent which allows a wide range of beam angle orientations to be used in external beam radiation therapy.

Source page: https://510kreport.com/device/K032248
Methodology: https://510kreport.com/methodology