510(k) · Cleared

Cleared

Portalvision

K003636510(k) TraditionalCleared Feb 2, 200170-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 Feb 2, 2001 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 101 later devices descend from it.

Decided: Feb 2, 2001
Review: 70 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 0

101 later devices descend from it, 6 citing it directly.

This deviceK003636 PortalvisionVarian Medical Systems, Inc. · 2001
Descendant · cites it directly · 79 of its ownK040192 ON-Board Imager DeviceVarian Medical Systems, Inc. · 2004 · Recalled
Descendant · 2 generations on · 76 of its ownK042720 ON-Board Imager DeviceVarian Medical Systems · 2004 · Recalled
Descendant · cites it directly · 61 of its ownK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
Descendant · 2 generations on · 43 of its ownK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
Descendant · 3 generations on · 37 of its ownK123291 TruebeamVarian Medical Systems, Inc. · 2012

Showing 5 of 101 descendants. See all descendants

Descendants cleared per year

2003high 11 (2023) · low 0 (2008)2026

Most influential descendants

Showing 5 of 101 · See all

K040192ON-Board Imager DeviceVarian Medical Systems, Inc. · 2004 · cites it directly79descendants
K042720ON-Board Imager DeviceVarian Medical Systems · 2004 · 2 generations on76descendants
K092871Trilogy MXVarian Medical Systems, Inc. · 2009 · cites it directly61descendants
K111106TruebeamVarian Medical Systems, Inc. · 2011 · 2 generations on43descendants
K123291TruebeamVarian Medical Systems, Inc. · 2012 · 3 generations on37descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003636	Portalvision	Varian Medical Systems, Inc.	2001	—
+1	K040192	ON-Board Imager Device	Varian Medical Systems, Inc.	2004	2
+2	K042720	ON-Board Imager Device	Varian Medical Systems	2004	5
+1	K092871	Trilogy MX	Varian Medical Systems, Inc.	2009	5
+2	K111106	Truebeam	Varian Medical Systems, Inc.	2011	5
+3	K123291	Truebeam	Varian Medical Systems, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	4	0
2005	1	0
2006	2	0
2007	1	0
2009	6	0
2010	3	0
2011	3	0
2012	4	0
2013	4	0
2014	5	0
2015	3	0
2016	2	0
2017	7	0
2018	6	0
2019	5	0
2020	6	0
2021	9	0
2022	6	0
2023	11	0
2024	3	0
2025	2	0
2026	7	0

FIG. 1 — Lineage of K003636, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (101)

See all 101

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K040192	ON-Board Imager Device	Varian Medical Systems, Inc.	2004	79
K092871	Trilogy MX	Varian Medical Systems, Inc.	2009	61
K031764	Oncor Avant-Garde with Coherence Workspaces	Siemens Medical Solutions USA, Inc.	2003	16
K091209	Portalvision Advanced Imaging	Varian Medical Systems, Inc.	2009	2
K101038	Rad II Simulator, Rad II KV Imager, Dual Rad II KV Imager	Acceletronics Digital Imaging, LLC	2010	0
K042733	Standard Imaging Pipspro QA Software System	Standard Imaging, Inc.	2004	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?

Of its descendants, K040192 (Varian Medical Systems, Inc., 2004) has gone furthest, with 79 descendants of its own.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

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	—

https://510kreport.com/device/K003636 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003636: Portalvision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003636

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026