510(k) · Cleared
Recalled · Class II · 2016Varian Head Frame
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · IYE Accelerator, Linear, Medical
Cleared on Dec 11, 2014 as substantially equivalent to K071360 (Varian Medical Systems, Inc., 2007) after a 91-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 11, 2014
- Review
- 91 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K971675 (1997). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK971675 SNT Stereotactic Localization SystemSurgical Navigation Technologies, Inc. · 1997
- 1 generation backK071360 Optical Guidance PlatformVarian Medical Systems, Inc. · 2007 · Recalled
- This deviceK142560 Varian Head FrameVarian Medical Systems, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK180586 Varian Head FrameVarian Medical Systems, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K180586Varian Head FrameVarian Medical Systems, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971675 | SNT Stereotactic Localization System | Surgical Navigation Technologies, Inc. | 1997 | — |
| −1 | K071360 | Optical Guidance Platform | Varian Medical Systems, Inc. | 2007 | 5 |
| 0 (this device) | K142560 | Varian Head Frame | Varian Medical Systems, Inc. | 2014 | — |
| +1 | K180586 | Varian Head Frame | Varian Medical Systems, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K071360 | Optical Guidance PlatformSummary page 4…on therapy system 21 CFR 892.5050, Class II Product Code: IYE III. Predicate Device: Optical Guidance Platform: K071360 IV. Device Description: The Head Frame provides rigid immobilization of a patient’s skull by att… | 2007 |
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 |
|---|---|---|---|
| K180586 | Varian Head Frame | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 13, 2016 | Class II | Z-0077-2017 | Device Design | Varian Medical Systems has received a report that a user was able to easily rotate the head frame posts when attached to the mounting cam on the metal head ring. There was no report of serious injury due to this issue |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 9.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K180586 (Varian Medical Systems, Inc., 2018) 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. 2014, 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 Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142560 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142560: Varian Head Frame.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142560
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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