510(k) · Cleared
ClearedDELTA4
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 12, 2006 as substantially equivalent to K031634 (Wellhofer Dosimetrie, 2003) after an 87-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Jan 12, 2006
- Review
- 87 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K935928 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK935928 Rit 113 Film Analysis SystemRadiological Imaging Technology, Inc. · 1994
- 1 generation backK031634 Omnipro I'mrtWellhofer Dosimetrie · 2003
- This deviceK052920 DELTA4Scandidos AB · 2006
- Descendant · cites it directly · 0 of its ownK151180 ScandiDos Delta4 Phantom+Scandidos AB · 2015
Most influential descendants
Showing 1 of 1 · See all- K151180ScandiDos Delta4 Phantom+Scandidos AB · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935928 | Rit 113 Film Analysis System | Radiological Imaging Technology, Inc. | 1994 | — |
| −1 | K031634 | Omnipro I'mrt | Wellhofer Dosimetrie | 2003 | — |
| 0 (this device) | K052920 | DELTA4 | Scandidos AB | 2006 | — |
| +1 | K151180 | ScandiDos Delta4 Phantom+ | Scandidos AB | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (3)
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 |
|---|---|---|---|
| * | K031634 | Omnipro I'mrtSummary page 1…D001 04 003 02 9_2 (9_6) 3 PREDICATE DEVICES OmniPro I'mRT 510(k) number K031634 Trade name OmniPro I'mRT Intended Use The intended use of the OmniPro I'mRT system is to: *… | 2003 |
| * | — | MapCheck Named without a submission number | |
| * | — | CIRS Model 008 Dynamic Thorax Phantom Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151180 | ScandiDos Delta4 Phantom+ | 2015 | 0 |
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 12 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K151180 (Scandidos AB, 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K031634.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The intended use of Delta4 is quality assurance of patient specific treatment delivery prior to the treatment in IMRT and 4DRT (respiratory gating and tumor tracking).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052920 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052920: DELTA4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052920
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