# K970384: Velos Constancy Check Device, Model 55-145

- Pathway: 510(k) (Traditional)
- Applicant: Aktina Medical Physics Corp.
- Decided: Jul 29, 1997 after 176 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 K874893 (1988). 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)
- K874893: Model 35300 Tracker (TM) Therapy Beam Evaluator, Keithley Instruments, Inc. (1988) Summary page 2.

## Indications for use
The AKTINA “Velos” Constancy Check Device, model 55-145, is intended for use in external beam radiation therapy in a similar way to that of the Tracker Therapy Beam Evaluation System (by Keithley Instruments, Inc.) previously cleared for marketing under K874893. More specifically, its intended use is for daily, morning checks of machine output by staff technologists, under the supervision of 2 medical physicist. Not intended as a substitute for machine calibrations or validations of machine beam energy, these checks are quality assurance steps to safeguard accepted standards of good practice in Radiation Oncology. “Velos” is designed to operate by either: a. being mounted on standard beamblock trays or, b. placed on a table, when measurements are needed from various SID’s and functions in an efficient and reliable way through reduction of setup time, remnote control readings via CCTV, output constancy checks at all gantry angles (for compliance with TG-43) and fixed geometry for elimination of distance errors.

Source page: https://510kreport.com/device/K970384
Methodology: https://510kreport.com/methodology