510(k) · Cleared
Recalled · Class II · 2017Agility
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 Apr 4, 2013 as substantially equivalent to K121328 (Elekta, Ltd., 2012) and 2 other predicates after a 114-day review. Its family tree reaches back 7 generations to 1995. 36 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 4, 2013
- Review
- 114 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 7 generations to K926449 (1995). 29 ancestors in all, the oldest K864886 (1987). 36 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 6 generations backK973889 Varian Multileaf Collimator with Dynamic Arc Therapy FeatureVarian Medical Systems, Inc. · 1997
- 5 generations backK990085 Millennium MLC -120Varian Assoc., Inc. · 1999 · Recalled
- 4 generations backK050442 Millennium Multi-Leaf CollimatorVarian Medical Systems · 2005 · Recalled
- 3 generations backK071992 High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems · 2007 · Recalled
- 2 generations backK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
- 1 generation backK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
- This deviceK123808 AgilityElekta, Ltd. · 2013
- Descendant · cites it directly · 31 of its ownK140528 True Beam, True Beam STX, EdgeVarian Medical Systems, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 25 of its ownK143224 TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 23 of its ownK162472 TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2017
- Descendant · 4 generations on · 15 of its ownK170817 HalcyonVarian Medical Systems, Inc. · 2017
- Descendant · 5 generations on · 14 of its ownK181032 HalcyonVarian Medical Systems, Inc. · 2018
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K140528True Beam, True Beam STX, EdgeVarian Medical Systems, Inc. · 2014 · cites it directly31descendants
- K143224TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2014 · 2 generations on25descendants
- K162472TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2017 · 3 generations on23descendants
- K170817HalcyonVarian Medical Systems, Inc. · 2017 · 4 generations on15descendants
- K181032HalcyonVarian Medical Systems, Inc. · 2018 · 5 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K926449 | Varian Multileaf Collimator, Release 4.0 | Varian Assoc., Inc. | 1995 | — |
| −6 | K973889 | Varian Multileaf Collimator with Dynamic Arc Therapy Feature | Varian Medical Systems, Inc. | 1997 | — |
| −5 | K990085 | Millennium MLC -120 | Varian Assoc., Inc. | 1999 | 2 |
| −4 | K050442 | Millennium Multi-Leaf Collimator | Varian Medical Systems | 2005 | 2 |
| −3 | K071992 | High-Definition 120 Multileaf Collimator (HD120 MLC) | Varian Medical Systems | 2007 | 4 |
| −2 | K092871 | Trilogy MX | Varian Medical Systems, Inc. | 2009 | 5 |
| −1 | K111106 | Truebeam | Varian Medical Systems, Inc. | 2011 | 5 |
| 0 (this device) | K123808 | Agility | Elekta, Ltd. | 2013 | — |
| +1 | K140528 | True Beam, True Beam STX, Edge | Varian Medical Systems, Inc. | 2014 | 2 |
| +2 | K143224 | TrueBeam-TrueBeam STx-Edge | Varian Medical Systems, Inc. | 2014 | 1 |
| +3 | K162472 | TrueBeam-TrueBeam STx-Edge | Varian Medical Systems, Inc. | 2017 | — |
| +4 | K170817 | Halcyon | Varian Medical Systems, Inc. | 2017 | — |
| +5 | K181032 | Halcyon | Varian Medical Systems, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K121328 | AgilitySummary page 1…ator Classification Name: Medical Linear Accelerator Accessory, 21 CFR 892.5050 Product Code: IYE Predicate Devices: Agility TM (K(121328), Varian RPM (983629), Varian TrueBeam Linear Accelerator (1111106) Product Description: This Tr… | 2012 |
| * | K983629 | RPM Respiratory Gating SystemSummary page 1…ame: Medical Linear Accelerator Accessory, 21 CFR 892.5050 Product Code: IYE Predicate Devices: Agility TM (K(121328), Varian RPM (983629), Varian TrueBeam Linear Accelerator (1111106) Product Description: This Traditional 510O(k) des… | 1999 |
| * | K111106 | TruebeamSummary page 1…Code: IYE Predicate Devices: Agility TM (K(121328), Varian RPM (983629), Varian TrueBeam Linear Accelerator (1111106) Product Description: This Traditional 510O(k) describes changes to the Elekta range of medical linear accelerators when fint… | 2011 |
What descends from it? (36)
See all 362 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-0723-2018 | Software Design Change | Potential for positional errors following automatic table movement (ATM). |
| Nov 25, 2013 | Class II | Z-1085-2014 | Software design | During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 22 of the 29 ancestors have a recall of any class.
- Of its descendants, K140528 (Varian Medical Systems, Inc., 2014) has gone furthest, with 31 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. 2013, 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 R3.1I 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 (181 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 R3.1I 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.
Both High Dose Rate mode and flattened beams are intended to be used for single or multiple fractions, delivered as static and/or dynamic, in gated or un-gated deliveries, in all areas of the body where such treatment is indicated.
The use of the Agility multileaf collimator in conjunction with an Elekta digital linear accelerator may be helpful in the delivery of radiation for treatment that includes but is not limited to malignant and benign brain tumors, brain metastases, spine lesions treated using SRS, squamous cell, carcinoma of the head and neck, lung, breast, pancreatic, hepatic malignancies treated using SERT, prostate, and bone metastases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123808 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123808: Agility.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123808
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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