510(k) · Cleared
ClearedFraxion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Intelligence Medizintechnik GmbH · IYE Accelerator, Linear, Medical
Cleared on Nov 22, 2011 as substantially equivalent to K051746 (Elekta Instrument AB, 2005) and 2 other predicates after a 113-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- Nov 22, 2011
- Review
- 113 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K924849 (1995). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK924849 Leksell Gamma Unit Model 23004,Type B.Elekta Radiosurgery, Inc. · 1995
- 4 generations backK984328 Leksell Gamma Knife Target System, Model 24001Elekta Instrument AB · 1999 · Recalled
- 3 generations backK061941 Leksell Gamma Knife Perfexion, Model 715000Elekta Instrument AB · 2006
- 2 generations backK063512 Leksell Gamma Knife PerfexionElekta Instrument AB · 2007 · Recalled
- 1 generation backK092083 Extend Frame System, Model 1009633Elekta Instrument AB · 2009 · Recalled
- This deviceK112210 FraxionMedical Intelligence Medizintechnik GmbH · 2011
- Descendant · cites it directly · 0 of its ownK132908 Trupoint Arch, Nasion Cushion, Bite Cup, Trupoint Arch Storage…Medtec, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K132908Trupoint Arch, Nasion Cushion, Bite Cup, Trupoint Arch Storage Plate, Trupoint Arch Base…Medtec, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K924849 | Leksell Gamma Unit Model 23004,Type B. | Elekta Radiosurgery, Inc. | 1995 | — |
| −4 | K984328 | Leksell Gamma Knife Target System, Model 24001 | Elekta Instrument AB | 1999 | 4 |
| −3 | K061941 | Leksell Gamma Knife Perfexion, Model 715000 | Elekta Instrument AB | 2006 | — |
| −2 | K063512 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | 2007 | 4 |
| −1 | K092083 | Extend Frame System, Model 1009633 | Elekta Instrument AB | 2009 | 1 |
| 0 (this device) | K112210 | Fraxion | Medical Intelligence Medizintechnik GmbH | 2011 | — |
| +1 | K132908 | Trupoint Arch, Nasion Cushion, Bite Cup, Trupoint Arch Storage Plate, Trupoint… | Medtec, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K051746 | Elekta Esarte Frame SystemSummary page 1…se to the following marketed devices: Elekta Esarie Frame System (K(051746), Elekra Extend System (K(092083), Medical Intelligence HeadFiX System (K(0304… | 2005 |
| * | K092083 | Extend Frame System, Model 1009633Summary page 1…to the following marketed devices: Elekta Esarie Frame System (K(051746), Elekra Extend System (K(092083), Medical Intelligence HeadFiX System (K(030439). 101 Device Descri… | 2009 |
| * | K030439 | HeadfixSummary page 1…(K(051746), Elekra Extend System (K(092083), Medical Intelligence HeadFiX System (K(030439). 101 Device Description: FrxoT is a device for cranial stereotactic radiotherapy and… | 2003 |
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 |
|---|---|---|---|
| K132908 | Trupoint Arch, Nasion Cushion, Bite Cup, Trupoint Arch Storage Plate, Trupoint Arch Base… | 2014 | 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 16 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K132908 (Medtec, Inc., 2014) has gone furthest, with 0 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. 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?
FraxionTM, is intended to be used for irmp bilisation, positioning and re-positioning during Stereotactic Radiotherapy (SRT) in all Paris of the brain and head in a Linear Accelerator environment.
Further FraxionTM is used to immobilise and position the head during image acquisition to support treatment planning.
Under certain circumstances (e.g. when the patient will not tolerate an invasive frame) FraxionTM may also be used for Sfereoteclic Radiosurgery (SRS) in a Linear Accelerator environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112210: Fraxion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112210
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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