510(k) · Cleared

Cleared

iViewDose R1.0

K153011510(k) TraditionalCleared Dec 11, 201558-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 Limited · IYE Accelerator, Linear, Medical

Cleared on Dec 11, 2015 as substantially equivalent to K112723 (Dosisoft SA, 2012) and 2 other predicates after a 58-day review. Its family tree reaches back 3 generations to 2001.

Decided: Dec 11, 2015
Review: 58 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K010225 (2001). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK010225 Dosimetry CheckMath Resolutions, LLC · 2001
2 generations backK101503 Dusimetry CheckMath Resolutions, LLC · 2010
1 generation backK112723 EpigrayDosisoft SA · 2012
This deviceK153011 iViewDose R1.0Elekta Limited · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K010225	Dosimetry Check	Math Resolutions, LLC	2001	—
−2	K101503	Dusimetry Check	Math Resolutions, LLC	2010	—
−1	K112723	Epigray	Dosisoft SA	2012	—
0 (this device)	K153011	iViewDose R1.0	Elekta Limited	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0

FIG. 1 — Lineage of K153011, 2001–2015Source: 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? (3)

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
*	K112723	Epigray Summary page 4 …ame: EPID Dosimetry Classification Name: Medical charged-particle radiation therapy system, 21 CFR 892.5050 Product Code: IYE Predicate Devices: DOSlsoft SA, EPIgray (K112723) Math Resolutions LLC, Dosimetry Check Version 4 Release 1 (K132605) Math Resolutions LLC, Dosimetry Check with Exit Dose (K10150…	Dosisoft SA	2012	—
*	K132605	Dosimetry Check Version 4 Release 1 Summary page 4 …adiation therapy system, 21 CFR 892.5050 Product Code: IYE Predicate Devices: DOSlsoft SA, EPIgray (K112723) Math Resolutions LLC, Dosimetry Check Version 4 Release 1 (K132605) Math Resolutions LLC, Dosimetry Check with Exit Dose (K101503) Product Description: This Traditional 510(k) describes a new st…	Math Resolutions, LLC	2013	—
*	K101503	Dusimetry Check Summary page 4 …edicate Devices: DOSlsoft SA, EPIgray (K112723) Math Resolutions LLC, Dosimetry Check Version 4 Release 1 (K132605) Math Resolutions LLC, Dosimetry Check with Exit Dose (K101503) Product Description: This Traditional 510(k) describes a new standalone software to be used with the Elekta range of medical l…	Math Resolutions, LLC	2010	—

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 14 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
None of the 4 ancestors has a recall.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?

iViewDose is a standalone software tool, available as an optional accessory of the linear accelerator. It is intended to assist in reducing the clinical risk in the delivery of radiotherapy treatments and does not alter the treatment delivery, or impact the clinical workflow. The software is to be used for the purposes of detecting gross errors during the delivery of radiation therapy. The software acquires data using the iViewGT Electronic Portal…

Read the full statement (204 words)

The software is to be used for the purposes of detecting gross errors during the delivery of radiation therapy. The software acquires data using the iViewGT Electronic Portal Imaging Device at the time of treatment (or prior to treatment) and subsequently processes it. The processed data is compared with data calculated by the treatment planning system. The comparison is derived from the application of dose conversion and reconstruction algorithms to the EPID data, which is back-projected to a plane normal to a beam (2D) or multiple planes (3D) inside the patient (in vivo) or phantom (pre-treatment).

iViewDose is not a treatment planning system, and provides an independent means of checking the dose delivered to the patient.

iViewDose therefore provides an added level of treatment assurance, thus giving clinicians greater confidence especially when complex treatment techniques are employed.

iViewDose is intended to support decision making in relation to the delivery of radiation to defined target volumes performed with Elekta linear accelerators only.

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/K153011 · printed Nov 6, 2026

Cite this page

510(k) Report. “K153011: iViewDose R1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153011

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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