# K180308: Prelude

- Pathway: 510(k) (Traditional)
- Applicant: Medcom GmbH
- Decided: Mar 27, 2018 after 53 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- 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: 13 generations back to K864210 (1986). 64 ancestors in all.
No later device cites it as a predicate yet.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171885: Radiance V4, Gmv Soluciones Globales Internet S.A.U. (2017) Summary page 5.
- (no number) Track-it: named in the summary without a submission number

## Indications for use
The Prelude Planning Software for the electron beam IORT treatment can be used for any malignant and benign tumor. For Prelude no limitation is given to the patient population. Local/Regional recommendations or guidelines may indicate patient who will benefit from IORT more than from other treatment modalities. In general, since Prelude is tailored for the planning with the Mobetron®, it can be used for IORT treatment planning, if a patient is prescribed to be treated with the Mobetron®.

Source page: https://510kreport.com/device/K180308
Methodology: https://510kreport.com/methodology