510(k) · Cleared
Recalled · Class II · 2013Agility
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta, Ltd. · IYE Accelerator, Linear, Medical
Cleared on Jun 12, 2012 as substantially equivalent to K082122 (Elekta, Ltd., 2008) after a 40-day review. Its family tree reaches back 2 generations to 1996. 37 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 12, 2012
- Review
- 40 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K963624 (1996). 37 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK963624 Philips Sli Series Linear AcceleratorPhilips Medical Systems, Inc. · 1996 · Recalled
- 1 generation backK082122 MLCI2Elekta, Ltd. · 2008 · Recalled
- This deviceK121328 AgilityElekta, Ltd. · 2012
- Descendant · cites it directly · 36 of its ownK123808 AgilityElekta, Ltd. · 2013 · Recalled
- Descendant · 2 generations on · 31 of its ownK140528 True Beam, True Beam STX, EdgeVarian Medical Systems, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 25 of its ownK143224 TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2014 · Recalled
- Descendant · 4 generations on · 23 of its ownK162472 TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2017
- Descendant · 5 generations on · 15 of its ownK170817 HalcyonVarian Medical Systems, Inc. · 2017
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K123808AgilityElekta, Ltd. · 2013 · cites it directly36descendants
- K140528True Beam, True Beam STX, EdgeVarian Medical Systems, Inc. · 2014 · 2 generations on31descendants
- K143224TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2014 · 3 generations on25descendants
- K162472TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2017 · 4 generations on23descendants
- K170817HalcyonVarian Medical Systems, Inc. · 2017 · 5 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963624 | Philips Sli Series Linear Accelerator | Philips Medical Systems, Inc. | 1996 | 2 |
| −1 | K082122 | MLCI2 | Elekta, Ltd. | 2008 | 1 |
| 0 (this device) | K121328 | Agility | Elekta, Ltd. | 2012 | — |
| +1 | K123808 | Agility | Elekta, Ltd. | 2013 | 2 |
| +2 | K140528 | True Beam, True Beam STX, Edge | Varian Medical Systems, Inc. | 2014 | 2 |
| +3 | K143224 | TrueBeam-TrueBeam STx-Edge | Varian Medical Systems, Inc. | 2014 | 1 |
| +4 | K162472 | TrueBeam-TrueBeam STx-Edge | Varian Medical Systems, Inc. | 2017 | — |
| +5 | K170817 | Halcyon | Varian Medical Systems, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K082122 | MLCI2Summary page 1…ollimator Classification Name: Medical Linear Accelerator Accessory; 21CFR 892.5050 Product Code: lYE Predicate Device: MLCi2 (082122) Product Description: This Traditional 510(k) describes the addition of the new Agility multileaf collimator beam limit… | 2008 |
What descends from it? (37)
See all 371 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123808 | Agility | 2013 | 36 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 25, 2013 | Class II | Z-1084-2014 | Software design | During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. |
| Apr 30, 2013 | Class II | Z-1402-2013 | Nonconforming Material/Component | Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0. |
| Jul 27, 2012 | Class II | Z-2340-2012 | Error in labeling | Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 11.7 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K123808 (Elekta, Ltd., 2013) has gone furthest, with 36 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed. The associated Integrity R3.0 software is the interface and control software for the Elekta medical digital linear accelerator 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…
Read the full statement (108 words)
The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.
The associated Integrity R3.0 software is the interface and control software for the Elekta medical digital linear accelerator 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 tumors), 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/K121328 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121328: Agility.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121328
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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