510(k) · Cleared
ClearedSNT Linac Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Navigation Technologies, Inc. · IYE Accelerator, Linear, Medical
Cleared on Nov 13, 1997 after a 175-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Nov 13, 1997
- Review
- 175 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK971893 SNT Linac AccessoriesSurgical Navigation Technologies, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK071360 Optical Guidance PlatformVarian Medical Systems, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 1 of its ownK142560 Varian Head FrameVarian Medical Systems, Inc. · 2014 · Recalled
- Descendant · cites it directly · 1 of its ownK123788 Integrated Collimator Verification and Interlock System (Icvi)Varian Medical Systems, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK180586 Varian Head FrameVarian Medical Systems, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK161984 Interlocked Circular Small Field Collimators, Elekta IntegratedAktina Medical Corporation · 2016
Most influential descendants
Showing 5 of 5 · See all- K071360Optical Guidance PlatformVarian Medical Systems, Inc. · 2007 · cites it directly2descendants
- K142560Varian Head FrameVarian Medical Systems, Inc. · 2014 · 2 generations on1descendant
- K123788Integrated Collimator Verification and Interlock System (Icvi)Varian Medical Systems, Inc. · 2013 · cites it directly1descendant
- K180586Varian Head FrameVarian Medical Systems, Inc. · 2018 · 3 generations on0descendants
- K161984Interlocked Circular Small Field Collimators, Elekta IntegratedAktina Medical Corporation · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971893 | SNT Linac Accessories | Surgical Navigation Technologies, Inc. | 1997 | — |
| +1 | K071360 | Optical Guidance Platform | Varian Medical Systems, Inc. | 2007 | 5 |
| +2 | K142560 | Varian Head Frame | Varian Medical Systems, Inc. | 2014 | 1 |
| +1 | K123788 | Integrated Collimator Verification and Interlock System (Icvi) | Varian Medical Systems, Inc. | 2013 | — |
| +3 | K180586 | Varian Head Frame | Varian Medical Systems, Inc. | 2018 | — |
| +2 | K161984 | Interlocked Circular Small Field Collimators, Elekta Integrated | Aktina Medical Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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?
The FDA summary names no predicate by number.
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, K071360 (Varian Medical Systems, Inc., 2007) 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 | — |
What is it indicated for?
The SNT Linac Accessories are indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery or Radiotherapy on cranial lesions. The accessories include a secondary collimation system, components to mount a patient in a stereotactic headring to a linear accelerator's treatment couch, and components to position the patient relative to the isocenter of a linear accelerator in conjuction with a laser alignment system.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971893 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971893: SNT Linac Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971893
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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