510(k) · Cleared

Cleared

Nucletron Plato External Beam Planning RTS V2 and RTS 3D V2

K964206510(k) TraditionalCleared Jun 20, 1997242-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. · IYE Accelerator, Linear, Medical

Cleared on Jun 20, 1997 as substantially equivalent to K921991 (Nucletron-Oldelft Corp., 1992) and 2 other predicates after a 242-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it.

Decided: Jun 20, 1997
Review: 242 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K914926 (1992). 7 ancestors in all, the oldest K894706 (1989). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK914926 Scandiplan - Version 338Scanditronix, Inc. · 1992
1 generation backK953391 Treatment Management SystemSiemens Medical Solutions USA, Inc. · 1996
This deviceK964206 Nucletron Plato External Beam Planning RTS V2 and RTS 3D V2Nucletron Corp. · 1997
Descendant · cites it directly · 0 of its ownK980629 VSS, Virtual Simulation SystemNucletron Corp. · 1998

Most influential descendants

Showing 1 of 1 · See all

K980629VSS, Virtual Simulation SystemNucletron Corp. · 1998 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K914926	Scandiplan - Version 338	Scanditronix, Inc.	1992	—
−1	K953391	Treatment Management System	Siemens Medical Solutions USA, Inc.	1996	—
0 (this device)	K964206	Nucletron Plato External Beam Planning RTS V2 and RTS 3D V2	Nucletron Corp.	1997	—
+1	K980629	VSS, Virtual Simulation System	Nucletron Corp.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1990	1	0
1992	1	0
1994	1	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K964206, 1992–1998Source: 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 IYE? 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 IYE device

#1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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? (3)

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
*	K921991	Plato Radiation Therapy Planning System Summary page 1 …assification Name: Medical Charged Particle Radiation Therapy System 21 CFR 892.5050 (Class II) stanti ivalence: Nucletron PLATO Radiation Therapy Planning System 510(k) K 921991 ADAC Pinnacle 3 APEX 510(k) K 951581 Siemens Treatment Management System (TMS) 510(k) K 953391 Device Description: The PLATO 3…	Nucletron-Oldelft Corp.	1992	—
*	K951581	PINNACLE3 Apex Summary page 1 …ticle Radiation Therapy System 21 CFR 892.5050 (Class II) stanti ivalence: Nucletron PLATO Radiation Therapy Planning System 510(k) K 921991 ADAC Pinnacle 3 APEX 510(k) K 951581 Siemens Treatment Management System (TMS) 510(k) K 953391 Device Description: The PLATO 3-D Treatment Planning System described…	Adac Laboratories	1996	—
*	K953391	Treatment Management System Summary page 1 …tanti ivalence: Nucletron PLATO Radiation Therapy Planning System 510(k) K 921991 ADAC Pinnacle 3 APEX 510(k) K 951581 Siemens Treatment Management System (TMS) 510(k) K 953391 Device Description: The PLATO 3-D Treatment Planning System described in this submissionis a computer-based external beam and br…	Siemens Medical Solutions USA, Inc.	1996	—

Also cleared against K921991: 2 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K980629	VSS, Virtual Simulation System	Nucletron Corp.	1998	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?

The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
None of the 7 ancestors has a recall.
Of its descendants, K980629 (Nucletron Corp., 1998) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K921991.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYE

12in 2025

2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007high 239 (2024) · low 44 (2007)2026

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

Recalls per year · IYE

1in 2025

2007high 78 (2007) · low 1 (2024)2026

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

Adverse event reports per year · IYE

101in 2025

2007high 280 (2011) · low 66 (2022)2025

MAUDE reports naming product code IYE, 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	23	44	78	155
2008	14	69	49	114
2009	20	63	22	174
2010	23	74	27	246
2011	11	94	73	280
2012	28	106	20	128
2013	18	88	11	96
2014	20	100	14	124
2015	20	108	8	100
2016	21	97	7	97
2017	23	94	7	125
2018	21	58	7	85
2019	19	83	2	91
2020	20	67	4	74
2021	19	86	5	68
2022	12	172	3	66
2023	18	129	7	128
2024	9	239	1	81
2025	12	170	1	101
2026	14	120	4	—

What is it indicated for?

PLATO 3-D Treatment Planning System is used to prepare individual treatment plans for cancer patients undergoing therapeutic radiation treatment. The system is utilized to develop plans for external photon and electron therapy. PLATO External Beam Planning RTS V2 and RTS 3D V2 has intended uses equivalent to its predecessor PLATO RTS V1. This device is used for external beam radiation therapy treatment planning for localization and treatment planning of…

Read the full statement (168 words)

PLATO External Beam Planning RTS V2 and RTS 3D V2 has intended uses equivalent to its predecessor PLATO RTS V1. This device is used for external beam radiation therapy treatment planning for localization and treatment planning of malignant and benign lesions of patients.

Treatment of cancer may require use of external radiation beams from an external source. Teletherapy unit coordinates of beam placement including gantry angle, field size, and shape along with accurately calculated predicted dose computation, are necessary in present day planning for radiotherapy. The ability to calculate both coplanar and noncoplanar beams to a highly accurate level is desirable by the industry. PLATO RTS V 2 allows for accuracy and speed to clinically facilitate this need. The recent use of linear accelerator Multileaf Collimators for field shaping is desired and supported by RTS V2.

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/K964206 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964206: Nucletron Plato External Beam Planning RTS V2 and RTS 3D V2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964206

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