510(k) · Cleared
Recalled · Class II · 2015Compass
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scanditronix Wellhofer GmbH · IYE Accelerator, Linear, Medical
Cleared on Dec 7, 2007 as substantially equivalent to K062817 (Ptw-New York Corp., 2006) and 2 other predicates after a 106-day review. Its family tree reaches back 3 generations to 1992. 31 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 7, 2007
- Review
- 106 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 3 generations to K914698 (1992). 11 ancestors in all, the oldest K874893 (1988). 31 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 2 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 1 generation backK012227 Mucheck - Monitor Unit Validation Program, Model V4.1Oncology Data Systems, Inc. · 2001
- This deviceK072374 CompassScanditronix Wellhofer GmbH · 2007
- Descendant · cites it directly · 23 of its ownK140660 MOBIUS3DMobius Medical Systems, LP · 2014 · Recalled
- Descendant · 2 generations on · 13 of its ownK153014 Mobius3DMobius Medical Systems, LP · 2016
- Descendant · 3 generations on · 5 of its ownK191761 Mobius3DVarian Medical Systems, Inc. · 2019
- Descendant · cites it directly · 5 of its ownK141800 PerfractionSun Nuclear Corporation · 2014
- Descendant · 4 generations on · 4 of its ownK192424 Mobius3DVarian Medical Systems, Inc. · 2019
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K140660MOBIUS3DMobius Medical Systems, LP · 2014 · cites it directly23descendants
- K153014Mobius3DMobius Medical Systems, LP · 2016 · 2 generations on13descendants
- K191761Mobius3DVarian Medical Systems, Inc. · 2019 · 3 generations on5descendants
- K141800PerfractionSun Nuclear Corporation · 2014 · cites it directly5descendants
- K192424Mobius3DVarian Medical Systems, Inc. · 2019 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −2 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −1 | K012227 | Mucheck - Monitor Unit Validation Program, Model V4.1 | Oncology Data Systems, Inc. | 2001 | — |
| 0 (this device) | K072374 | Compass | Scanditronix Wellhofer GmbH | 2007 | — |
| +1 | K140660 | MOBIUS3D | Mobius Medical Systems, LP | 2014 | 1 |
| +2 | K153014 | Mobius3D | Mobius Medical Systems, LP | 2016 | — |
| +3 | K191761 | Mobius3D | Varian Medical Systems, Inc. | 2019 | — |
| +1 | K141800 | Perfraction | Sun Nuclear Corporation | 2014 | — |
| +4 | K192424 | Mobius3D | Varian Medical Systems, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062817 | PTW David Imrt QC Verification SystemSummary page 1…e Accelerator, linear, medical 5.6 Classification name Medical charged-particle radiation therapy system (21 CFR 892.5050, Product Code lYE) 5.7 Predicate devices K062817 David (PTW), K031634 OmnniPro I'mnRT (Scanditronix Wellhdfer), K012227 muCheck (Oncology Data Systems, Inc.), Delta4 (Scandidos… | 2006 |
| * | K031634 | Omnipro I'mrtSummary page 1…r, medical 5.6 Classification name Medical charged-particle radiation therapy system (21 CFR 892.5050, Product Code lYE) 5.7 Predicate devices K062817 David (PTW), K031634 OmnniPro I'mnRT (Scanditronix Wellhdfer), K012227 muCheck (Oncology Data Systems, Inc.), Delta4 (Scandidos AB) 5.8 Device desc… | 2003 |
| * | K012227 | Mucheck - Monitor Unit Validation Program, Model V4.1Summary page 1…ed-particle radiation therapy system (21 CFR 892.5050, Product Code lYE) 5.7 Predicate devices K062817 David (PTW), K031634 OmnniPro I'mnRT (Scanditronix Wellhdfer), K012227 muCheck (Oncology Data Systems, Inc.), Delta4 (Scandidos AB) 5.8 Device description The system is intended to be used with int… | 2001 |
| * | — | Delta4 (Scandidos AB) Named without a submission number |
What descends from it? (31)
See all 314 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 2, 2015 | Class II | Z-1212-2015 | Software design (manufacturing process) | 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 beam on will not be scaled correctly… |
| Sep 25, 2014 | Class II | Z-0168-2015 | Software design | 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 delivered dose. |
| Aug 20, 2013 | Class II | Z-0456-2014 | Software design | 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 conditions this problem generates too large ROI… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 6.0 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K140660 (Mobius Medical Systems, LP, 2014) has gone furthest, with 23 descendants of its own.
- 2 other devices also cite its predicate K062817.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072374 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072374: Compass.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072374
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026