510(k) · Cleared
Recalled · Class II · 2017Integrity (TM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta Limited · IYE Accelerator, Linear, Medical
Cleared on Dec 16, 2011 as substantially equivalent to K102200 (Elekta, Ltd., 2010) after a 100-day review. Its family tree reaches back 5 generations to 1996. It has been recalled 3 times.
- Decided
- Dec 16, 2011
- Review
- 100 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 5 generations to K963624 (1996). No later device cites it as a predicate yet.
- Root · 5 generations backK963624 Philips Sli Series Linear AcceleratorPhilips Medical Systems, Inc. · 1996 · Recalled
- 4 generations backK032996 Elekta Synergy SystemElekta Oncology Systems, Ltd. · 2003 · Recalled
- 3 generations backK051932 Elekta Synergy; Elekta Synergy S and XVIR3.5Elekta, Inc. · 2005 · Recalled
- 2 generations backK080585 Desktop ProElekta, Ltd. · 2008 · Recalled
- 1 generation backK102200 Integrity Model 1014284Elekta, Ltd. · 2010
- This deviceK112613 Integrity (TM)Elekta Limited · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K963624 | Philips Sli Series Linear Accelerator | Philips Medical Systems, Inc. | 1996 | 2 |
| −4 | K032996 | Elekta Synergy System | Elekta Oncology Systems, Ltd. | 2003 | 3 |
| −3 | K051932 | Elekta Synergy; Elekta Synergy S and XVIR3.5 | Elekta, Inc. | 2005 | 14 |
| −2 | K080585 | Desktop Pro | Elekta, Ltd. | 2008 | 1 |
| −1 | K102200 | Integrity Model 1014284 | Elekta, Ltd. | 2010 | — |
| 0 (this device) | K112613 | Integrity (TM) | Elekta Limited | 2011 | — |
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 |
|---|---|---|---|
| * | K102200 | Integrity Model 1014284Summary page 1…al charged-particle radiation therapy system, 21CFR 892.5050 Product Code: lYE Predicate Device: Integrity Tm R1.0 (K102200) Product Description: This Traditional 510O(k) describes enhancements to the integral software performing the… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 20, 2017 | Class II | Z-0724-2018 | Software Design Change | Potential for positional errors following automatic table movement (ATM). |
| Nov 25, 2013 | Class II | Z-1083-2014 | Software design | During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. |
| Mar 28, 2013 | Class II | Z-1322-2014 | Software design | The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 4 of the 5 ancestors have a recall of any class.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
IntegrityTM is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g: lesions, arterio-venous malformations, malignant and benign tumours), whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112613 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112613: Integrity (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112613
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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