510(k) · Cleared

Cleared

Radcalc, Model V.4.0

K010464510(k) TraditionalCleared May 17, 200190-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

Lifeline Software, Inc. · IYE Accelerator, Linear, Medical

Cleared on May 17, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 47 later devices descend from it.

Decided: May 17, 2001
Review: 90 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 0

47 later devices descend from it, 5 citing it directly.

This deviceK010464 Radcalc, Model V.4.0Lifeline Software, Inc. · 2001
Descendant · cites it directly · 40 of its ownK012227 Mucheck - Monitor Unit Validation Program, Model V4.1Oncology Data Systems, Inc. · 2001
Descendant · 2 generations on · 31 of its ownK072374 CompassScanditronix Wellhofer GmbH · 2007 · Recalled
Descendant · 3 generations on · 23 of its ownK140660 MOBIUS3DMobius Medical Systems, LP · 2014 · Recalled
Descendant · 2 generations on · 21 of its ownK061152 Mucheck V7.0Oncology Data Systems, Inc. · 2006
Descendant · cites it directly · 17 of its ownK090531 Radcalc Software, Version 6.0Lifeline Software, Inc. · 2009

Showing 5 of 47 descendants. See all descendants

Descendants cleared per year

2001high 5 (2016) · low 0 (2002)2026

Most influential descendants

Showing 5 of 47 · See all

K012227Mucheck - Monitor Unit Validation Program, Model V4.1Oncology Data Systems, Inc. · 2001 · cites it directly40descendants
K072374CompassScanditronix Wellhofer GmbH · 2007 · 2 generations on31descendants
K140660MOBIUS3DMobius Medical Systems, LP · 2014 · 3 generations on23descendants
K061152Mucheck V7.0Oncology Data Systems, Inc. · 2006 · 2 generations on21descendants
K090531Radcalc Software, Version 6.0Lifeline Software, Inc. · 2009 · cites it directly17descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010464	Radcalc, Model V.4.0	Lifeline Software, Inc.	2001	—
+1	K012227	Mucheck - Monitor Unit Validation Program, Model V4.1	Oncology Data Systems, Inc.	2001	—
+2	K072374	Compass	Scanditronix Wellhofer GmbH	2007	3
+3	K140660	MOBIUS3D	Mobius Medical Systems, LP	2014	1
+2	K061152	Mucheck V7.0	Oncology Data Systems, Inc.	2006	—
+1	K090531	Radcalc Software, Version 6.0	Lifeline Software, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2003	1	0
2006	1	0
2007	1	0
2008	2	0
2009	3	0
2010	1	0
2013	1	0
2014	2	0
2015	1	0
2016	5	0
2017	3	0
2018	2	0
2019	3	0
2020	2	0
2021	1	0
2022	4	0
2023	2	0
2024	3	0
2025	4	0
2026	4	0

FIG. 1 — Lineage of K010464, 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? (47)

See all 47

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

Number	Device	Applicant	Decided	Descendants
K012227	Mucheck - Monitor Unit Validation Program, Model V4.1	Oncology Data Systems, Inc.	2001	40
K090531	Radcalc Software, Version 6.0	Lifeline Software, Inc.	2009	17
K031975	Imsure	Prodigm, Inc.	2003	6
K082606	Commissioning Data Management System (CDMS)	D3 Radiation Planning	2008	1
K090182	Module Integrated Radiotherapy System (Mirs)	Nuclemed S.A.	2009	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, K012227 (Oncology Data Systems, Inc., 2001) has gone furthest, with 40 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/K010464 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010464: Radcalc, Model V.4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010464

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Record history

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