510(k) · Cleared

Cleared

Peacock System

K963258510(k) TraditionalCleared Nov 18, 199690-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

Nomos Corp. · IYE Accelerator, Linear, Medical

Cleared on Nov 18, 1996 as substantially equivalent to K852842 (Nucletron-Oldelft Corp., 1986) and 2 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1981. 31 later devices descend from it.

Decided: Nov 18, 1996
Review: 90 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K802809 (1981). 3 ancestors in all. 31 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK802809 Electron Arc TherapyVarian Assoc., Inc. · 1981
This deviceK963258 Peacock SystemNomos Corp. · 1996
Descendant · cites it directly · 24 of its ownK993766 Helax-TMS V 5.0 Radiation Therapy Treatment Planning SystemHelax AB · 1999
Descendant · 2 generations on · 23 of its ownK010682 Helax-TMS V 5.1 Radiation Therapy Treatment Planning SystemMds Nordion · 2001
Descendant · 3 generations on · 22 of its ownK020971 DCM 2.0Mds Nordion AB · 2002
Descendant · 4 generations on · 21 of its ownK130617 RaystationRaysearch Laboratories AB · 2013 · Recalled
Descendant · 5 generations on · 19 of its ownK140187 Ray StationRaysearch Laboratories AB · 2014 · Recalled

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

1999high 4 (2021) · low 0 (2000)2026

Most influential descendants

Showing 5 of 31 · See all

K993766Helax-TMS V 5.0 Radiation Therapy Treatment Planning SystemHelax AB · 1999 · cites it directly24descendants
K010682Helax-TMS V 5.1 Radiation Therapy Treatment Planning SystemMds Nordion · 2001 · 2 generations on23descendants
K020971DCM 2.0Mds Nordion AB · 2002 · 3 generations on22descendants
K130617RaystationRaysearch Laboratories AB · 2013 · 4 generations on21descendants
K140187Ray StationRaysearch Laboratories AB · 2014 · 5 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K802809	Electron Arc Therapy	Varian Assoc., Inc.	1981	—
0 (this device)	K963258	Peacock System	Nomos Corp.	1996	—
+1	K993766	Helax-TMS V 5.0 Radiation Therapy Treatment Planning System	Helax AB	1999	—
+2	K010682	Helax-TMS V 5.1 Radiation Therapy Treatment Planning System	Mds Nordion	2001	—
+3	K020971	DCM 2.0	Mds Nordion AB	2002	—
+4	K130617	Raystation	Raysearch Laboratories AB	2013	6
+5	K140187	Ray Station	Raysearch Laboratories AB	2014	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
1989	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	2	0
2001	1	0
2002	1	0
2003	1	0
2010	1	0
2013	1	0
2014	2	0
2015	2	0
2016	1	0
2017	3	0
2018	2	0
2019	1	0
2020	2	0
2021	4	0
2022	2	0
2023	2	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K963258, 1981–2026Source: 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 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

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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
*	K852842	Selectron HDR Remote Afterloader Summary page 1 …ad Sewickley, PA 15143 2. Names of Predicate Devices' Int ted PEACOCK Treal { Planni \| Deli Systern: Varian Varisource HDR Afterloader with integrated planning system (K852842) GE Target Planning System (K896353) & Arc Therapy (K802809) These systems were marketed prior to and/or following enactment of…	Nucletron-Oldelft Corp.	1986	—
*	K896353	GE Target Series 2 Summary page 1 …Predicate Devices' Int ted PEACOCK Treal { Planni \| Deli Systern: Varian Varisource HDR Afterloader with integrated planning system (K852842) GE Target Planning System (K896353) & Arc Therapy (K802809) These systems were marketed prior to and/or following enactment of the Medlcal Device Amendments on May…	GE Medical Systems	1989	—
*	K802809	Electron Arc Therapy Summary page 1 …ed PEACOCK Treal { Planni \| Deli Systern: Varian Varisource HDR Afterloader with integrated planning system (K852842) GE Target Planning System (K896353) & Arc Therapy (K802809) These systems were marketed prior to and/or following enactment of the Medlcal Device Amendments on May 28, 1976. 3. Classuflc…	Varian Assoc., Inc.	1981	—

What descends from it? (31)

See all 31

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

Number	Device	Applicant	Decided	Descendants
K993766	Helax-TMS V 5.0 Radiation Therapy Treatment Planning System	Helax AB	1999	24
K032209	Nomos Corvus 5.0M	Nomos Corp.	2003	4
K993359	Raptor Treatment Planning System	Nomos Corp.	1999	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?

None of the 3 ancestors has a recall.
Of its descendants, K993766 (Helax AB, 1999) has gone furthest, with 24 descendants of its own.

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?

This device is intended to be used as an integrated system for the planning and delivery of dynamic conformal radiation therapy to produce a radiation field which is modulated to conform to the projected tumor volume plus margins by means of a dynamic (moving) multileaf collimator, while simultaneously moving the accelerator gantry.

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/K963258 · printed Nov 4, 2026

Cite this page

510(k) Report. “K963258: Peacock System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963258

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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