# K140660: MOBIUS3D

- Pathway: 510(k) (Traditional)
- Applicant: Mobius Medical Systems, LP
- Decided: Jun 24, 2014 after 102 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K914698 (1992). 13 ancestors in all.
23 later devices descend from it; 7 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072374: Compass, Scanditronix Wellhofer GmbH (2007) Summary page 1.
- K032886: Diamond Setup 2000, K&S Assoc., Inc. (2004) Summary page 1.

## Most influential descendants
- K153014: Mobius3D (2016), 13 descendants of its own
- K191761: Mobius3D (2019), 5 descendants of its own
- K192424: Mobius3D (2019), 4 descendants of its own
- K171350: Collision Check (2017), 4 descendants of its own
- K161946: DoseCHECK (2016), 4 descendants of its own

## Recalls of this device
- Feb 23, 2015 · Class II · Z-2100-2017: Mobius3D version 1.5.0 contained a defect in software code which affects users who perform beam customization, and may lead to a discrepancy in dose calculation between this version of Mobius3D (1.5.0

## Indications for use
Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool.

Source page: https://510kreport.com/device/K140660
Methodology: https://510kreport.com/methodology