510(k) · Cleared
Recalled · 2012MLCI2
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 Aug 29, 2008 as substantially equivalent to K963624 (Philips Medical Systems, Inc., 1996) after a 32-day review. Its family tree reaches back 1 generation to 1996. 38 later devices descend from it. It has been recalled once.
- Decided
- Aug 29, 2008
- Review
- 32 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963624 (1996). 38 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK963624 Philips Sli Series Linear AcceleratorPhilips Medical Systems, Inc. · 1996 · Recalled
- This deviceK082122 MLCI2Elekta, Ltd. · 2008
- Descendant · cites it directly · 37 of its ownK121328 AgilityElekta, Ltd. · 2012 · Recalled
- Descendant · 2 generations on · 36 of its ownK123808 AgilityElekta, Ltd. · 2013 · Recalled
- Descendant · 3 generations on · 31 of its ownK140528 True Beam, True Beam STX, EdgeVarian Medical Systems, Inc. · 2014 · Recalled
- Descendant · 4 generations on · 25 of its ownK143224 TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2014 · Recalled
- Descendant · 5 generations on · 23 of its ownK162472 TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2017
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K121328AgilityElekta, Ltd. · 2012 · cites it directly37descendants
- K123808AgilityElekta, Ltd. · 2013 · 2 generations on36descendants
- K140528True Beam, True Beam STX, EdgeVarian Medical Systems, Inc. · 2014 · 3 generations on31descendants
- K143224TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2014 · 4 generations on25descendants
- K162472TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2017 · 5 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963624 | Philips Sli Series Linear Accelerator | Philips Medical Systems, Inc. | 1996 | 2 |
| 0 (this device) | K082122 | MLCI2 | Elekta, Ltd. | 2008 | — |
| +1 | K121328 | Agility | Elekta, Ltd. | 2012 | 3 |
| +2 | K123808 | Agility | Elekta, Ltd. | 2013 | 2 |
| +3 | K140528 | True Beam, True Beam STX, Edge | Varian Medical Systems, Inc. | 2014 | 2 |
| +4 | K143224 | TrueBeam-TrueBeam STx-Edge | Varian Medical Systems, Inc. | 2014 | 1 |
| +5 | K162472 | TrueBeam-TrueBeam STx-Edge | Varian Medical Systems, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K963624 | Philips Sli Series Linear AcceleratorSummary page 1…MLCi2 Common Name: Multileaf Collimator Classification Name: Medical Linear Accelerator Accessory, lYE Predicate Device: MLCi (K963624) Product Description: This Special 510(k) describes modifications to the MLCi multileaf collimator for use as an accessory… | 1996 |
What descends from it? (38)
See all 381 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121328 | Agility | 2012 | 37 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 19, 2012 | Not classified | Z-1651-2012 | Nonconforming Material/Component | The Y2 diaphragm block was found loose. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 MLCi2 Multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082122 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082122: MLCI2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082122
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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