510(k) · Cleared

Cleared

Modification to: Viewgt Electronic Portal Imaging Device (Epid)

K012289510(k) SpecialCleared Aug 14, 200125-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

Elekta Oncology Systems, Ltd. · IYE Accelerator, Linear, Medical

Cleared on Aug 14, 2001 as substantially equivalent to K981790 (Elekta Oncology Systems, Ltd., 1998) after a 25-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.

Decided: Aug 14, 2001
Review: 25 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K981790 (1998). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK981790 Iview Electronic Portal Imaging Device (Epid) Model Number IvewElekta Oncology Systems, Ltd. · 1998 · Recalled
This deviceK012289 Modification to: Viewgt Electronic Portal Imaging Device (Epid)Elekta Oncology Systems, Ltd. · 2001
Descendant · cites it directly · 0 of its ownK042733 Standard Imaging Pipspro QA Software SystemStandard Imaging, Inc. · 2004

Most influential descendants

Showing 1 of 1 · See all

K042733Standard Imaging Pipspro QA Software SystemStandard Imaging, Inc. · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K981790	Iview Electronic Portal Imaging Device (Epid) Model Number Ivew	Elekta Oncology Systems, Ltd.	1998	1
0 (this device)	K012289	Modification to: Viewgt Electronic Portal Imaging Device (Epid)	Elekta Oncology Systems, Ltd.	2001	—
+1	K042733	Standard Imaging Pipspro QA Software System	Standard Imaging, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K012289, 1998–2004Source: 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
*	K981790	Iview Electronic Portal Imaging Device (Epid) Model Number Ivew Summary page 2 …- 1) The ViewGT™ EPID is an enhancement to the existing iView Electronic Portal Imaging Device which has previously bgen cleared for commercial distribution under D.C. K981790. These devices have an established and proven track record for safety. The primary reason for this modification to support solid…	Elekta Oncology Systems, Ltd.	1998	1

Also cleared against K981790: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
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?

Its one ancestor has a recall.
Of its descendants, K042733 (Standard Imaging, Inc., 2004) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K981790.

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	—

What is it indicated for?

The EOS iViewGT™ Electronic Portal Imaging Device (EPID), as with the predicate iView, is intended to be used with radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

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/K012289 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012289: Modification to: Viewgt Electronic Portal Imaging Device (Epid).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012289

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026