510(k) · Cleared

Recalled · Class II · 2014

Iplan RT

K103246510(k) TraditionalCleared Mar 16, 2011133-day reviewClass II21 CFR 892.5050Recalls 2

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

Brainlab AG · MUJ System, Planning, Radiation Therapy Treatment

Cleared on Mar 16, 2011 as substantially equivalent to K080886 (Brainlab AG, 2008) and 1 other predicate after a 133-day review. Its family tree reaches back 5 generations to 1992. 32 later devices descend from it. It has been recalled 2 times.

Decided: Mar 16, 2011
Review: 133 days
Class: Class II
Product code: MUJ
Recalls: 2
Predicates: 2

Its longest line of descent runs back 5 generations to K920879 (1992). 15 ancestors in all. 32 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 5 generations backK920879 Brainscan Radiosurgery ModuleBrainlab · 1992 · Recalled
4 generations backK994413 BrainscanBrainlab AG · 2000 · Recalled
3 generations backK032511 Intuition ImageBrainlab AG · 2004
2 generations backK052220 Iplan RT FibertrackingBrainlab AG · 2005
1 generation backK080886 Iplan RT ImageBrainlab AG · 2008
This deviceK103246 Iplan RTBrainlab AG · 2011
Descendant · cites it directly · 22 of its ownK120387 RaystationRaysearch Laboratories AB · 2012 · Recalled
Descendant · 2 generations on · 21 of its ownK130617 RaystationRaysearch Laboratories AB · 2013 · Recalled
Descendant · 3 generations on · 19 of its ownK140187 Ray StationRaysearch Laboratories AB · 2014 · Recalled
Descendant · 4 generations on · 17 of its ownK141860 RaystationRaysearch Laboratories AB · 2014 · Recalled
Descendant · 5 generations on · 16 of its ownK160093 RayStationRaySearch Laboratories AB (PUBL) · 2016 · Recalled

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2012high 5 (2021) · low 0 (2024)2026

Most influential descendants

Showing 5 of 32 · See all

K120387RaystationRaysearch Laboratories AB · 2012 · cites it directly22descendants
K130617RaystationRaysearch Laboratories AB · 2013 · 2 generations on21descendants
K140187Ray StationRaysearch Laboratories AB · 2014 · 3 generations on19descendants
K141860RaystationRaysearch Laboratories AB · 2014 · 4 generations on17descendants
K160093RayStationRaySearch Laboratories AB (PUBL) · 2016 · 5 generations on16descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K920879	Brainscan Radiosurgery Module	Brainlab	1992	1
−4	K994413	Brainscan	Brainlab AG	2000	1
−3	K032511	Intuition Image	Brainlab AG	2004	—
−2	K052220	Iplan RT Fibertracking	Brainlab AG	2005	—
−1	K080886	Iplan RT Image	Brainlab AG	2008	—
0 (this device)	K103246	Iplan RT	Brainlab AG	2011	—
+1	K120387	Raystation	Raysearch Laboratories AB	2012	6
+2	K130617	Raystation	Raysearch Laboratories AB	2013	6
+3	K140187	Ray Station	Raysearch Laboratories AB	2014	1
+4	K141860	Raystation	Raysearch Laboratories AB	2014	5
+5	K160093	RayStation	RaySearch Laboratories AB (PUBL)	2016	7

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1999	1	0
2001	3	0
2002	1	0
2004	1	0
2006	2	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	1	0
2014	3	0
2015	1	0
2016	1	0
2017	3	0
2018	2	0
2019	1	0
2020	1	0
2021	5	0
2022	2	0
2023	4	0
2025	5	0
2026	2	0

FIG. 1 — Lineage of K103246, 1992–2026Source: 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? (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
*	K080886	Iplan RT Image Summary page 1 …y Class Class 11 FDA Establishment. Registration 8043933 Number Predicate Device Predicate Device: iPlan RT Image 510 (k): K080886 Predicate Device: iPlan RT Dose 510 (k): K080888…	Brainlab AG	2008	—
*	K080888	Modeification to Iplan RT Dose Summary page 1 …933 Number Predicate Device Predicate Device: iPlan RT Image 510 (k): K080886 Predicate Device: iPlan RT Dose 510 (k): K080888 Page 1 of 3 Intended Use iP…	Brainlab AG	2008	3

What descends from it? (32)

See all 32

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

Number	Device	Applicant	Decided	Descendants
K120387	Raystation	Raysearch Laboratories AB	2012	22
K142108	RT Elements, Dose Review, Brain Metastases, Adaptive Hybrid Surgery Analysis	Brainlab AG	2014	5
K203681	RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT…	Brainlab AG	2021	2

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 19, 2014	Class II	Z-0957-2015	Software in the Use Environment	iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets.
Nov 19, 2014	Class II	Z-0956-2015	Software in the Use Environment	iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
4 of the 15 ancestors have a recall of any class.
Of its descendants, K120387 (Raysearch Laboratories AB, 2012) has gone furthest, with 22 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. 2011, this device’s year, is highlighted.

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?

Plan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K103246 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103246: Iplan RT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103246

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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