510(k) · Cleared
ClearedBrainlab CT/X-Ray Localizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab Med. Computersysteme GmbH · IYE Accelerator, Linear, Medical
Cleared on Aug 5, 1996 after a 287-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Aug 5, 1996
- Review
- 287 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK954861 Brainlab CT/X-Ray LocalizerBrainlab Med. Computersysteme GmbH · 1996
- Descendant · cites it directly · 2 of its ownK053500 Frameless Radiosurgery ComponentsBrainlab AG · 2006
- Descendant · 2 generations on · 1 of its ownK202050 Cranial 4Pi ImmobilizationBrainlab AG · 2020
- Descendant · cites it directly · 1 of its ownK081935 Stereotactic Head and Neck Localizer, Model 50-100Aktina Medical Physics Corp. · 2008
- Descendant · 3 generations on · 0 of its ownK243142 Cranial 4Pi ImmobilizationBrainlab AG · 2025
- Descendant · 2 generations on · 0 of its ownK103616 Pinpoint Stereotactic Head and Neck LocalizerAktina Medical Physics Corp. · 2011
Most influential descendants
Showing 5 of 5 · See all- K053500Frameless Radiosurgery ComponentsBrainlab AG · 2006 · cites it directly2descendants
- K202050Cranial 4Pi ImmobilizationBrainlab AG · 2020 · 2 generations on1descendant
- K081935Stereotactic Head and Neck Localizer, Model 50-100Aktina Medical Physics Corp. · 2008 · cites it directly1descendant
- K243142Cranial 4Pi ImmobilizationBrainlab AG · 2025 · 3 generations on0descendants
- K103616Pinpoint Stereotactic Head and Neck LocalizerAktina Medical Physics Corp. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954861 | Brainlab CT/X-Ray Localizer | Brainlab Med. Computersysteme GmbH | 1996 | — |
| +1 | K053500 | Frameless Radiosurgery Components | Brainlab AG | 2006 | — |
| +2 | K202050 | Cranial 4Pi Immobilization | Brainlab AG | 2020 | — |
| +1 | K081935 | Stereotactic Head and Neck Localizer, Model 50-100 | Aktina Medical Physics Corp. | 2008 | — |
| +3 | K243142 | Cranial 4Pi Immobilization | Brainlab AG | 2025 | — |
| +2 | K103616 | Pinpoint Stereotactic Head and Neck Localizer | Aktina Medical Physics Corp. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K053500 (Brainlab AG, 2006) has gone furthest, with 2 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.
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 | — |
https://510kreport.com/device/K954861 · printed Nov 4, 2026
Cite this page
510(k) Report. “K954861: Brainlab CT/X-Ray Localizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954861
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026