510(k) · Cleared

Recalled · Class II · 2014

Genesis Imrt Linear Accelerator

K982502510(k) SpecialCleared Jul 31, 199811-day reviewClass II21 CFR 892.5050Recalls 4

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

Siemens Medical Solutions USA, Inc. · IYE Accelerator, Linear, Medical

Cleared on Jul 31, 1998 as substantially equivalent to K882729 (Siemens Medical Laboratories, Inc., 1988) after an 11-day review. Its family tree reaches back 1 generation to 1988. 28 later devices descend from it. It has been recalled 4 times.

Decided: Jul 31, 1998
Review: 11 days
Class: Class II
Product code: IYE
Recalls: 4
Predicates: 1

Its longest line of descent runs back 1 generation to K882729 (1988). 28 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK882729 Mevatron, M 2 ClassSiemens Medical Laboratories, Inc. · 1988 · Recalled
This deviceK982502 Genesis Imrt Linear AcceleratorSiemens Medical Solutions USA, Inc. · 1998
Descendant · cites it directly · 27 of its ownK013673 HI-Art SystemTomo Therapy, Inc. · 2002
Descendant · 2 generations on · 26 of its ownK033347 Modification to: HI-Art SystemTomotherapy Incorporated · 2003
Descendant · 3 generations on · 25 of its ownK042739 HI-Art SystemTomotherapy Incorporated · 2004
Descendant · 4 generations on · 24 of its ownK060912 Modification to: HI-Art SystemTomotherapy Incorporated · 2006 · Recalled
Descendant · 5 generations on · 13 of its ownK082005 Modification to HI-Art Treatment SystemTomotherapy Incorporated · 2008 · Recalled

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2002high 3 (2009) · low 0 (2005)2026

Most influential descendants

Showing 5 of 28 · See all

K013673HI-Art SystemTomo Therapy, Inc. · 2002 · cites it directly27descendants
K033347Modification to: HI-Art SystemTomotherapy Incorporated · 2003 · 2 generations on26descendants
K042739HI-Art SystemTomotherapy Incorporated · 2004 · 3 generations on25descendants
K060912Modification to: HI-Art SystemTomotherapy Incorporated · 2006 · 4 generations on24descendants
K082005Modification to HI-Art Treatment SystemTomotherapy Incorporated · 2008 · 5 generations on13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K882729	Mevatron, M 2 Class	Siemens Medical Laboratories, Inc.	1988	38
0 (this device)	K982502	Genesis Imrt Linear Accelerator	Siemens Medical Solutions USA, Inc.	1998	—
+1	K013673	HI-Art System	Tomo Therapy, Inc.	2002	—
+2	K033347	Modification to: HI-Art System	Tomotherapy Incorporated	2003	—
+3	K042739	HI-Art System	Tomotherapy Incorporated	2004	—
+4	K060912	Modification to: HI-Art System	Tomotherapy Incorporated	2006	4
+5	K082005	Modification to HI-Art Treatment System	Tomotherapy Incorporated	2008	7

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	1	0
2006	1	0
2008	1	0
2009	3	0
2010	1	0
2011	3	0
2012	2	0
2013	1	0
2014	2	0
2015	1	0
2016	2	0
2017	2	0
2018	2	0
2020	2	0
2021	1	0
2023	1	0

FIG. 1 — Lineage of K982502, 1988–2023Source: 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

Get a 510(k) Report

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
*	K882729	Mevatron, M 2 Class Summary page 1 …sification Name: Medical Charged Particle Radiation Therapy System 21 CFR § 892.5710 Class I, Product Code: RA 90 IYE 3. Predicate Device: MEVATRON M Class, 510(k) No. K882729 4. Description of Device: The GENESIS™ Linear Accelerator is a single energy, high dose medical linear accelerator. The GENESIS™…	Siemens Medical Laboratories, Inc.	1988	38

Also cleared against K882729: 2 other devices →

What descends from it? (28)

See all 28

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

Number	Device	Applicant	Decided	Descendants
K013673	HI-Art System	Tomo Therapy, Inc.	2002	27

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 19, 2014	Class II	Z-1059-2015	Component design/selection	A hardware update to replace the old PCB Assembly, Head Driver-G41 with PCB with overcurrent protection as a result of reports of the electric board inside the gantry showing signs of overheating, including thermal damage and smoke…
May 28, 2014	Class II	Z-2174-2014	Use error	A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment have the potential to lead to a collision…
May 29, 2013	Class II	Z-1663-2013	Process change control	The information regarding the FILM Mode calibration may have been considered difficult to interpret when translated. SIEMENS HEALTHCARE CR / RADIATION ONCOLOGY had become aware that this issue may have resulted in mistreatment of patients.
Nov 4, 2010	Not classified	Z-2639-2011	Other	The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K013673 (Tomo Therapy, Inc., 2002) has gone furthest, with 27 descendants of its own.
2 other devices also cite its predicate K882729.

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 GENESIS IMRT Linear Accelerator is intended to deliver megavoltage

x-ray treatment for therapeutic application in the treatment of cancer. The

GENESIS delivers these treatments conformally, shaping the field of

radiation to the tumor volume. The depth of penetration emulating from the

GENESIS ideally suits itself for treating deep-seated tumors while providing

a skin sparing effect.

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/K982502 · printed Nov 5, 2026

Cite this page

510(k) Report. “K982502: Genesis Imrt Linear Accelerator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982502

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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