510(k) · Cleared

Cleared

Plato SRS Stereotactic Radiosurgery Planning System,Model 2.0, Plato Ifs Image Fusion Software, Model 2.1

K010784510(k) SpecialCleared Apr 10, 200126-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

Nucletron Corp. · MUJ System, Planning, Radiation Therapy Treatment

Cleared on Apr 10, 2001 after a 26-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 34 later devices descend from it.

Decided: Apr 10, 2001
Review: 26 days
Class: Class II
Product code: MUJ
Recalls: None
Predicates: 0

34 later devices descend from it, 3 citing it directly.

This deviceK010784 Plato SRS Stereotactic Radiosurgery Planning System,Model 2.0, Plato…Nucletron Corp. · 2001
Descendant · cites it directly · 30 of its ownK031281 Ergo SRS3D Line USA, Inc. · 2003
Descendant · 2 generations on · 29 of its ownK080601 Ergo++ Version 1.73D Line Medical Systems S.R.L. · 2008 · Recalled
Descendant · 3 generations on · 13 of its ownK141572 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2014 · Recalled
Descendant · 4 generations on · 12 of its ownK183034 MOSAIQ Oncology Information SystemElekta, Inc. · 2018 · Recalled
Descendant · 3 generations on · 12 of its ownK091179 Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc. · 2009 · Recalled

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2003high 4 (2009) · low 0 (2004)2026

Most influential descendants

Showing 5 of 34 · See all

K031281Ergo SRS3D Line USA, Inc. · 2003 · cites it directly30descendants
K080601Ergo++ Version 1.73D Line Medical Systems S.R.L. · 2008 · 2 generations on29descendants
K141572Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2014 · 3 generations on13descendants
K183034MOSAIQ Oncology Information SystemElekta, Inc. · 2018 · 4 generations on12descendants
K091179Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc. · 2009 · 3 generations on12descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010784	Plato SRS Stereotactic Radiosurgery Planning System,Model 2.0, Plato Ifs Image…	Nucletron Corp.	2001	—
+1	K031281	Ergo SRS	3D Line USA, Inc.	2003	—
+2	K080601	Ergo++ Version 1.7	3D Line Medical Systems S.R.L.	2008	2
+3	K141572	Mosaiq Oncology Information System	Impac Medical Systems, Inc.	2014	11
+4	K183034	MOSAIQ Oncology Information System	Elekta, Inc.	2018	2
+3	K091179	Monaco RTP System, Vmat Option	Computerized Medical Systems, Inc.	2009	5

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2008	1	0
2009	4	0
2010	1	0
2011	1	0
2012	1	0
2013	1	0
2014	1	0
2015	1	0
2018	2	0
2019	2	0
2020	3	0
2021	4	0
2022	2	0
2023	4	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K010784, 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? (34)

See all 34

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

Number	Device	Applicant	Decided	Descendants
K031281	Ergo SRS	3D Line USA, Inc.	2003	30
K030821	Simuplan Treatment Planning System, Model V. 7.5	Simuplan S.L.	2003	2
K090182	Module Integrated Radiotherapy System (Mirs)	Nuclemed S.A.	2009	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, K031281 (3D Line USA, Inc., 2003) has gone furthest, with 30 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/K010784 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010784: Plato SRS Stereotactic Radiosurgery Planning System,Model 2.0, Plato Ifs Image Fusion Software, Model 2.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010784

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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