510(k) · Cleared

Cleared

P3IMRT TM

K002237510(k) TraditionalCleared Feb 2, 2001193-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

Adac Laboratories · MUJ System, Planning, Radiation Therapy Treatment

Cleared on Feb 2, 2001 after a 193-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 73 later devices descend from it.

Decided: Feb 2, 2001
Review: 193 days
Class: Class II
Product code: MUJ
Recalls: None
Predicates: 0

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

This deviceK002237 P3IMRT TMAdac Laboratories · 2001
Descendant · cites it directly · 44 of its ownK032724 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2003 · Recalled
Descendant · 2 generations on · 39 of its ownK041577 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2004 · Recalled
Descendant · 3 generations on · 29 of its ownK080799 Atlas-Based AutosegmentationComputerized Medical Systems, Inc. · 2008
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

Showing 5 of 73 descendants. See all descendants

Descendants cleared per year

2002high 6 (2009) · low 0 (2025)2026

Most influential descendants

Showing 5 of 73 · See all

K032724PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2003 · cites it directly44descendants
K041577PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2004 · 2 generations on39descendants
K080799Atlas-Based AutosegmentationComputerized Medical Systems, Inc. · 2008 · 3 generations on29descendants
K013673HI-Art SystemTomo Therapy, Inc. · 2002 · cites it directly27descendants
K033347Modification to: HI-Art SystemTomotherapy Incorporated · 2003 · 2 generations on26descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002237	P3IMRT TM	Adac Laboratories	2001	—
+1	K032724	PINNACLE3 Radiation Therapy Planning System	Adac Laboratories	2003	1
+2	K041577	PINNACLE3 Radiation Therapy Planning System	Adac Laboratories	2004	7
+3	K080799	Atlas-Based Autosegmentation	Computerized Medical Systems, Inc.	2008	—
+1	K013673	HI-Art System	Tomo Therapy, Inc.	2002	—
+2	K033347	Modification to: HI-Art System	Tomotherapy Incorporated	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	3	0
2004	4	0
2005	2	0
2006	4	0
2007	1	0
2008	3	0
2009	6	0
2010	3	0
2011	5	0
2012	5	0
2013	2	0
2014	3	0
2015	4	0
2016	3	0
2017	2	0
2018	4	0
2019	2	0
2020	4	0
2021	3	0
2022	2	0
2023	3	0
2024	1	0
2026	3	0

FIG. 1 — Lineage of K002237, 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 MUJ? 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 MUJ device

#1 K232799 syngo.via RT Image Suitescore 18.6 · 19 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? (73)

See all 73

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

Number	Device	Applicant	Decided	Descendants
K032724	PINNACLE3 Radiation Therapy Planning System	Adac Laboratories	2003	44
K013673	HI-Art System	Tomo Therapy, Inc.	2002	27
K042861	Odyssey	Permedics, Inc.	2005	2
K041971	Wimrt Module for Artp Planning System	Prodigm Group, Inc.	2005	1
K032456	Prowess	Prowess, Inc.	2003	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, K032724 (Adac Laboratories, 2003) has gone furthest, with 44 descendants of its own.

How does its category compare?

All MUJ devices

MUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MUJ

10in 2025

2007high 16 (2009) · low 4 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MUJ

186in 2025

2007high 233 (2026) · low 30 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MUJ

2in 2023

2007high 23 (2010) · low 0 (2024)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MUJ

21in 2025

2007high 78 (2010) · low 9 (2024)2025

MAUDE reports naming product code MUJ, 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	4	67	4	24
2008	9	63	10	51
2009	16	84	11	24
2010	11	56	23	78
2011	9	103	17	73
2012	8	59	4	39
2013	5	64	6	33
2014	9	108	2	35
2015	13	78	7	30
2016	5	80	13	27
2017	7	30	4	16
2018	7	53	3	25
2019	9	56	4	25
2020	9	104	2	26
2021	11	87	4	15
2022	8	168	3	22
2023	10	140	2	76
2024	9	122	0	9
2025	10	186	0	21
2026	9	233	2	—

https://510kreport.com/device/K002237 · printed Nov 5, 2026

Cite this page

510(k) Report. “K002237: P3IMRT TM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002237

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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