510(k) · Cleared
ClearedLINACwatch, LinacView
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qualiformed Sarl · IYE Accelerator, Linear, Medical
Cleared on Oct 27, 2017 as substantially equivalent to K140660 (Mobius Medical Systems, LP, 2014) and 1 other predicate after a 66-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Oct 27, 2017
- Review
- 66 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K914698 (1992). 15 ancestors in all, the oldest K874893 (1988). No later device cites it as a predicate yet.
- Root · 5 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 4 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 3 generations backK012227 Mucheck - Monitor Unit Validation Program, Model V4.1Oncology Data Systems, Inc. · 2001
- 2 generations backK072374 CompassScanditronix Wellhofer GmbH · 2007 · Recalled
- 1 generation backK140660 MOBIUS3DMobius Medical Systems, LP · 2014 · Recalled
- This deviceK172534 LINACwatch, LinacViewQualiformed Sarl · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −4 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −3 | K012227 | Mucheck - Monitor Unit Validation Program, Model V4.1 | Oncology Data Systems, Inc. | 2001 | — |
| −2 | K072374 | Compass | Scanditronix Wellhofer GmbH | 2007 | 3 |
| −1 | K140660 | MOBIUS3D | Mobius Medical Systems, LP | 2014 | 1 |
| 0 (this device) | K172534 | LINACwatch, LinacView | Qualiformed Sarl | 2017 | — |
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 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2014 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K140660 | MOBIUS3DSummary page 5…te Predicate Equivalent Devices: QualiFormeD 510(k) Number Manufacturer / Model Model QualiFormeD K140660 Mobius Medical Systems Mobius3D LINACWATCH / LINACVIEW K141800… | 2014 |
| * | K141800 | PerfractionSummary page 5…QualiFormeD K140660 Mobius Medical Systems Mobius3D LINACWATCH / LINACVIEW K141800 Sun Nuclear Corporation Model 1215 PerFRACTION… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 6 companies; a new generation was cleared every 6.0 years on median.
- 2 of the 15 ancestors have a recall of any class.
- 6 other devices also cite its predicate K140660.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
QualiFormeD LINACWATCH / LINACVIEW is stand-alone software that analyzes radiation therapy machine (linear accelerator) performance for each fraction automatically using log files provided by the radiation therapy machine.
It is to be used by trained radiation oncology personnel as a guide to alert this professional to potential machine delivery issues that can affect treatment quality and workflow.
QualiFormeD LINACWATCH / LINACVIEW is not primary treatment planning or 3D dose calculation software, and cannot be used to generate radiotherapy treatment plans.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172534 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172534: LINACwatch, LinacView.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172534
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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