# K232738: BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)

- Pathway: 510(k) (Traditional)
- Applicant: Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla
- Decided: May 31, 2024 after 267 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 K854880 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103193: Doseview 3D, Standard Imaging, Inc. (2010) Summary page 4.

## Indications for use
BeamDose is a software for the following purposes in radiotherapy: – absolute dose measurements as field class dosemeter (according to IEC 60731) – monitor calibration – positioning of detectors in PTW water phantoms The software enables the user of a BEAMSCAN, TANDEM, TANDEM XDR, UNIDOS E, UNIDOS webline, UNIDOS Tango, UNIDOS Romeo or MULTIDOS electrometer to operate the electrometer as a therapy dosemeter in accordance with IEC 60731. The software establishes the communication with the electrometer, provides calibration and correction factors for various detectors and displays the measurement results. Additionally, the software enables the positioning of a measuring detector in the desired measuring depth with a motorized PTW water phantom. The measured absolute dose values must not be used directly in radiation therapy. They have to be checked for plausibility by qualified personnel. The software must be used only by qualified personnel, usually the medical physicist responsible for the radiotherapy system or an authorized person.

Source page: https://510kreport.com/device/K232738
Methodology: https://510kreport.com/methodology