510(k) · Cleared

Cleared

Xplan 2.2 with the Body System

K013661510(k) SpecialCleared Dec 3, 200127-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

Radionics, A Division of Tyco Healthcare Group LP · MUJ System, Planning, Radiation Therapy Treatment

Cleared on Dec 3, 2001 as substantially equivalent to K001700 (Radionics, Inc., 2000) and 1 other predicate after a 27-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.

Decided: Dec 3, 2001
Review: 27 days
Class: Class II
Product code: MUJ
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K001700 (2000). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK001700 XPLAN 2.1Radionics, Inc. · 2000
This deviceK013661 Xplan 2.2 with the Body SystemRadionics, A Division of Tyco Healthcare Group LP · 2001
Descendant · cites it directly · 1 of its ownK041997 Radionics Xknife RT 3 with Non Stereotactic ModuleRadionics, A Division of Tyco Healthcare Group LP · 2004
Descendant · 2 generations on · 0 of its ownK061893 Integra Radionics Xknife RT 4Integra Radionics, Inc. · 2006

Most influential descendants

Showing 2 of 2 · See all

K041997Radionics Xknife RT 3 with Non Stereotactic ModuleRadionics, A Division of Tyco Healthcare Group LP · 2004 · cites it directly1descendant
K061893Integra Radionics Xknife RT 4Integra Radionics, Inc. · 2006 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001700	XPLAN 2.1	Radionics, Inc.	2000	—
0 (this device)	K013661	Xplan 2.2 with the Body System	Radionics, A Division of Tyco Healthcare Group LP	2001	—
+1	K041997	Radionics Xknife RT 3 with Non Stereotactic Module	Radionics, A Division of Tyco Healthcare Group LP	2004	—
+2	K061893	Integra Radionics Xknife RT 4	Integra Radionics, Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	1	0

FIG. 1 — Lineage of K013661, 2000–2006Source: 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

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What was it cleared against? (2)

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
*	K001700	XPLAN 2.1 Summary page 1 …rapy system. 3.0 The above device is substantial equivalent to the Radionics XPlan 2.1 Stereotactic Radiation Treatment Planning System Software was cleared via 510(k), K001700, on June 28, 2000 and the Med-Tec (Medical Intelligence) BodyFix System was cleared via 510(k), K001052, on August 30, 2000. 4.0…	Radionics, Inc.	2000	—
*	K001052	Med-Tec (Medical Intelligence) Bodyfix System, Model MT-BFX Summary page 1 …iation Treatment Planning System Software was cleared via 510(k), K001700, on June 28, 2000 and the Med-Tec (Medical Intelligence) BodyFix System was cleared via 510(k), K001052, on August 30, 2000. 4.0 The above system consists of stereotactic treatment planning software and hardware to immobilize and lo…	Med-Tec,Inc.	2000	—

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K041997	Radionics Xknife RT 3 with Non Stereotactic Module	Radionics, A Division of Tyco Healthcare Group LP	2004	1

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?

None of the 2 ancestors has a recall.
Of its descendants, K041997 (Radionics, A Division of Tyco Healthcare Group LP, 2004) has gone furthest, with 1 descendant 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	—

What is it indicated for?

XPlan 2.2 software is a stereotactic LINAC-based rz;ggn treatment planning system. XPlan 2.2 with the Body System localizes lesions to be treated using CT scans, MR scans, and digitized angiographic film. XPlan 2.2 with the Body System provides stereotactic planning system for treatment of tumors. The conformal stereotactic radiation therapy treatments are delivered over multiple fractions.

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/K013661 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013661: Xplan 2.2 with the Body System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013661

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026