# K191646: Beamscan MR

- Pathway: 510(k) (Traditional)
- Applicant: Ptw-Freiburg Physikalisch-Technische-Werkstaetten
- Decided: Feb 21, 2020 after 246 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 K954165 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161807: Beamscan, Ptw-Freiburg Physikalisch Technische-Werksraetten (2017) Summary page 4.

## Most influential descendants
- K200907: Thales 3D Mr Scanner (2020), 0 descendants of its own

## Indications for use
The BEAMSCAN MR system is used preferably in combined MRI-radiation therapy systems with static magnetic fields of up to 1.5T and is intended to collect beam data in water under the aspect of machine QA for the following purposes: - acceptance testing and/or commissioning of a combined MRI-radiation therapy system - measurements after repair or replacement of major treatment unit components of a combined MRI-Radiation therapy system - beam data analysis according to international therapy dosimetry protocols - acquisition, formatting and transfer of basic data to treatment planning systems - periodic QA procedures, e.g. constancy check - high precision data acquisition for scientific research (not a medical device indication)

Source page: https://510kreport.com/device/K191646
Methodology: https://510kreport.com/methodology