510(k) · Cleared

Cleared

Varian Head Frame

K180586510(k) SpecialCleared Apr 2, 201828-day reviewClass II21 CFR 892.5050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Varian Medical Systems, Inc. · IYE Accelerator, Linear, Medical

Cleared on Apr 2, 2018 as substantially equivalent to K142560 (Varian Medical Systems, Inc., 2014) after a 28-day review. Its family tree reaches back 3 generations to 1997.

Decided: Apr 2, 2018
Review: 28 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K971675 (1997). 8 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK971675 SNT Stereotactic Localization SystemSurgical Navigation Technologies, Inc. · 1997
2 generations backK071360 Optical Guidance PlatformVarian Medical Systems, Inc. · 2007 · Recalled
1 generation backK142560 Varian Head FrameVarian Medical Systems, Inc. · 2014 · Recalled
This deviceK180586 Varian Head FrameVarian Medical Systems, Inc. · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K971675	SNT Stereotactic Localization System	Surgical Navigation Technologies, Inc.	1997	—
−2	K071360	Optical Guidance Platform	Varian Medical Systems, Inc.	2007	5
−1	K142560	Varian Head Frame	Varian Medical Systems, Inc.	2014	1
0 (this device)	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

FIG. 1 — Lineage of K180586, 1997–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K142560	Varian Head Frame Summary page 4 …21 CFR 892.5050, Class II Product Code: IYE Common/Usual Head Frame Name: Predicate Device: Varian Head Frame K142560 Device Description: The Head Frame provides rigid immobilization of a patient’s skull by attaching a rigid halo…	Varian Medical Systems, Inc.	2014	1

What descends from it?

No later submission names this one as a predicate yet.

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 21 years and passes through 2 companies; a new generation was cleared every 7.5 years on median.
2 of the 8 ancestors have a recall of any class.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · IYE

12in 2025

2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007high 239 (2024) · low 44 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYE

1in 2025

2007high 78 (2007) · low 1 (2024)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYE

101in 2025

2007high 280 (2011) · low 66 (2022)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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K180586 · printed Nov 6, 2026

Cite this page

510(k) Report. “K180586: 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/K180586

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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