# K200907: Thales 3D Mr Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Lap GmbH Laser Applikationen
- Decided: Jun 3, 2020 after 58 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: 3 generations back to K954165 (1995). 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)
- K191646: Beamscan MR, Ptw-Freiburg Physikalisch-Technische-Werkstaetten (2020) Summary page 5.

## Indications for use
The THALES 3D MR SCANNER system is designed to measure the characteristic radiation beam for an irradiation unit. The beam data is stored in the software program and can be exported from there for use during commissioning in a treatment planning system (TPS) or for quality assurance. The THALES 3D MR SCANNER system can be used with irradiation units with integrated magnetic resonance imaging and a magnetic field of less than or equal to 0.35 tesla.

Source page: https://510kreport.com/device/K200907
Methodology: https://510kreport.com/methodology