510(k) · Cleared
ClearedDelta4 Insight
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scandidos AB · IYE Accelerator, Linear, Medical
Cleared on Jan 16, 2024 as substantially equivalent to K180595 (Radialogica, LLC, 2018) after a 454-day review. Its family tree reaches back 7 generations to 1992.
- Decided
- Jan 16, 2024
- Review
- 454 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K914698 (1992). 16 ancestors in all, the oldest K874893 (1988). No later device cites it as a predicate yet.
- Root · 7 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 6 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 5 generations backK012227 Mucheck - Monitor Unit Validation Program, Model V4.1Oncology Data Systems, Inc. · 2001
- 4 generations backK072374 CompassScanditronix Wellhofer GmbH · 2007 · Recalled
- 3 generations backK140660 MOBIUS3DMobius Medical Systems, LP · 2014 · Recalled
- 2 generations backK161946 DoseCHECKSun Nuclear Corporation · 2016
- 1 generation backK180595 SciMoCaRadialogica, LLC · 2018
- This deviceK223234 Delta4 InsightScandidos AB · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −6 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −5 | K012227 | Mucheck - Monitor Unit Validation Program, Model V4.1 | Oncology Data Systems, Inc. | 2001 | — |
| −4 | K072374 | Compass | Scanditronix Wellhofer GmbH | 2007 | 3 |
| −3 | K140660 | MOBIUS3D | Mobius Medical Systems, LP | 2014 | 1 |
| −2 | K161946 | DoseCHECK | Sun Nuclear Corporation | 2016 | — |
| −1 | K180595 | SciMoCa | Radialogica, LLC | 2018 | — |
| 0 (this device) | K223234 | Delta4 Insight | Scandidos AB | 2024 | — |
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 |
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? (1)
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 |
|---|---|---|---|
| * | K180595 | SciMoCaSummary page 4…Registered 510(k) Premarket submission Establishment Number number SciMoCa 3009140718 K180595 4 DESCRIPTION OF THE DEVICE Delta4 Insight is software specifically design for quality assurance of r… | 2018 |
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 32 years and passes through 8 companies; a new generation was cleared every 5.8 years on median.
- 2 of the 16 ancestors have a recall of any class.
- 2 other devices also cite its predicate K180595.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Delta4 Insight is a software intended to provide quality assurance of radiotherapy treatment plans by an independent dose calculation.
Delta4 Insight is not a treatment planning system or a radiation delivery device. Information provided by Delta4 Insight shall not be used to directly modify or influence radiation treatments. Delta4 Insight is to be used only by trained radiation oncology personnel for quality assurance purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223234 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223234: Delta4 Insight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223234
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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