# K072374: Compass

- Pathway: 510(k) (Traditional)
- Applicant: Scanditronix Wellhofer GmbH
- Decided: Dec 7, 2007 after 106 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K914698 (1992). 11 ancestors in all.
31 later devices descend from it; 4 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062817: PTW David Imrt QC Verification System, Ptw-New York Corp. (2006) Summary page 1.
- K031634: Omnipro I'mrt, Wellhofer Dosimetrie (2003) Summary page 1.
- K012227: Mucheck - Monitor Unit Validation Program, Model V4.1, Oncology Data Systems, Inc. (2001) Summary page 1.
- (no number) Delta4 (Scandidos AB): named in the summary without a submission number

## Most influential descendants
- K140660: MOBIUS3D (2014), 23 descendants of its own
- K153014: Mobius3D (2016), 13 descendants of its own
- K191761: Mobius3D (2019), 5 descendants of its own
- K141800: Perfraction (2014), 5 descendants of its own
- K192424: Mobius3D (2019), 4 descendants of its own

## Recalls of this device
- Feb 2, 2015 · Class II · Z-1212-2015: Error in the software. During internal tests of the current development version of the Compass SW it was found that dose reconstruction for DMLC plans when the jaws move or mlc leaves reverse during b
- Sep 25, 2014 · Class II · Z-0168-2015: Error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can result in an over or under-estimation of the pretreatment del
- Aug 20, 2013 · Class II · Z-0456-2014: The development partner of IBA informed that there is problem in a SW component used in COMPASS when converting Region of Interest (ROI) geometries to dose grid representation. Under certain condition

## Indications for use
COMPASS is used for quality assurance and plan verification in external beam radiation therapy for multileaf collimated fields and intensity modulated fields. It computes dose (energy per volume deposited by ionizing radiation) three-dimensionally in a geometrical representation of a patient or a phantom. The calculation is based on read-in treatment plans, and additionally on online or offline measurements of radiation fields with radiation-transparent or non-transparent, 2 dimensional multi-element ionization chamber arrays.

Source page: https://510kreport.com/device/K072374
Methodology: https://510kreport.com/methodology