510(k) · Cleared

Cleared

Trimed Plan, Version 2.2

K031088510(k) TraditionalCleared Jul 23, 2004476-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

Trimed Systems, Inc. · MUJ System, Planning, Radiation Therapy Treatment

Cleared on Jul 23, 2004 as substantially equivalent to K962950 (Varian Medical Systems, Inc., 1997) after a 476-day review. Its family tree reaches back 1 generation to 1997.

Decided: Jul 23, 2004
Review: 476 days
Class: Class II
Product code: MUJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K962950 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK962950 Cadplan, Version 2.62. Radiation Therapy Treatment Planning SystemVarian Medical Systems, Inc. · 1997
This deviceK031088 Trimed Plan, Version 2.2Trimed Systems, Inc. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K962950	Cadplan, Version 2.62. Radiation Therapy Treatment Planning System	Varian Medical Systems, Inc.	1997	—
0 (this device)	K031088	Trimed Plan, Version 2.2	Trimed Systems, Inc.	2004	—

FIG. 1 — Lineage of K031088, 1997–2004Source: 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 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? (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
*	K962950	Cadplan, Version 2.62. Radiation Therapy Treatment Planning System Summary page 1 …Predicate Device: CadPlan Version 2.62 Radiation Therapy Treatment Planning System K962950 Varian Cadplan 4. Description: TriMed Plan is a comprehensive 3D radiati…	Varian Medical Systems, Inc.	1997	—

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?

Its one ancestor has no recall.

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	—

What is it indicated for?

TriMed Plan is a radiation treatment planning software developed by TriMed Systems, Inc, running on IBM compatible personal computers with Microsoft Windows operating systems. TriMed Plan provides radiation treatment planning capability, for both photon and electron external beam sources, to satisfy the prescription of the radiation oncology. TriMed Plan uses 3D conformal therapy treatment approaches to combine modality plans, asymmetric and non-coplanar…

Read the full statement (95 words)

TriMed Plan is a radiation treatment planning software developed by TriMed Systems, Inc, running on IBM compatible personal computers with Microsoft Windows operating systems.

TriMed Plan provides radiation treatment planning capability, for both photon and electron external beam sources, to satisfy the prescription of the radiation oncology. TriMed Plan uses 3D conformal therapy treatment approaches to combine modality plans, asymmetric and non-coplanar fields, total body irradiation, multi-leaf collimators, hand blocking, customized blocking, and wedges. The resulting treatment plan from this system is to be evaluated, modified as necessary, approved and delivered by qualified medical personnel.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031088 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031088: Trimed Plan, Version 2.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031088

Report an extraction error

Are you the manufacturer?

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