# K173926: DORADOnova MR3T

- Pathway: 510(k) (Traditional)
- Applicant: Lap GmbH Laser Applikationen
- Decided: Sep 14, 2018 after 262 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 K981153 (1999). 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)
- K052682: Alignrt, Vision RT Limited (2006) Summary page 5.

## Indications for use
The DORADOnova MR3T system assists in reproducible patient positioning during radiation therapy planning and is utilized during treatment planning workflow. The DORADOnova MR3T system projects visual laser beams which can be positioned at specified coordinates via a control system. The position coordinates are typically chosen by the operator or provided by an external system (e.g. treatment planning system). The DORADOnova MR3T system is allowed to be used in MR environment with a magnetic field, less or equal to 3 Tesla.

Source page: https://510kreport.com/device/K173926
Methodology: https://510kreport.com/methodology