510(k) Report

510(k) · Cleared

Cleared

Peacock Plan

K940663510(k) TraditionalCleared Apr 9, 1996781-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 Apr 9, 1996 as substantially equivalent to K884261 (Small Systems Group, Inc., 1989) and 2 other predicates after a 781-day review. Its family tree reaches back 1 generation to 1989. 57 later devices descend from it.

Decided
Apr 9, 1996
Review
781 days
Class
Class II
Product code
IYE
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K884261 (1989). 3 ancestors in all. 57 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1990: 1 other ancestor1989: 1 other ancestor2003: 2 descendants cleared1999: 2 descendants cleared1998: 1 descendant cleared2000: 1 descendant cleared2005: 1 descendant cleared2010: 2 descendants cleared2009: 1 descendant cleared2002: 2 descendants cleared2001: 1 descendant cleared2006: 1 descendant cleared2015: 4 descendants cleared2013: 1 descendant cleared2020: 3 descendants cleared2016: 2 descendants cleared2012: 3 descendants cleared2011: 1 descendant cleared2014: 4 descendants cleared2021: 5 descendants cleared2018: 4 descendants cleared2019: 2 descendants cleared2017: 3 descendants cleared2022: 3 descendants cleared2024: 1 descendant cleared2026: 3 descendants cleared2023: 2 descendants cleared2025: 2 descendants clearedReference device: K841997 · CT 9800 · General Electric Co. · 1984Reference device: K910859 · Computerized Tomography X-Ray System · Siemens Medical Solutions USA, Inc. · 1991K884261 · Prowess 2000 · Small Systems Group, Inc. · 19891990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 7 descendants2 generations forward: 4 descendants3 generations forward: 3 descendants4 generations forward: 3 descendants5 generations forward: 9 descendants6 generations forward: 5 descendants7 generations forward: 3 descendants8 generations forward: 3 descendants9 generations forward: 3 descendants10 generations forward: 2 descendants11 generations forward: 2 descendants12 generations forward: 4 descendants13 generations forward: 2 descendants14 generations forward: 2 descendants15 generations forward: 2 descendants16 generations forward: 1 descendant17 generations forward: 1 descendant18 generations forward: 1 descendant K884261 · Prowess 2000 · Small Systems Group, Inc. · 19890+5+10+15
  1. Root · 1 generation backK884261 Prowess 2000Small Systems Group, Inc. · 1989
  2. This deviceK940663 Peacock PlanNomos Corp. · 1996
  3. Descendant · cites it directly · 27 of its ownK984532 Cadplan Helios Option 6.0Varian Medical Systems, Inc. · 1999
  4. Descendant · cites it directly · 24 of its ownK993766 Helax-TMS V 5.0 Radiation Therapy Treatment Planning SystemHelax AB · 1999
  5. Descendant · 2 generations on · 23 of its ownK010682 Helax-TMS V 5.1 Radiation Therapy Treatment Planning SystemMds Nordion · 2001
  6. Descendant · 3 generations on · 22 of its ownK020971 DCM 2.0Mds Nordion AB · 2002
  7. Descendant · 4 generations on · 21 of its ownK130617 RaystationRaysearch Laboratories AB · 2013 · Recalled

Showing 5 of 57 descendants. See all descendants

Descendants cleared per year

1998: 11999: 22000: 12001: 12002: 22003: 22005: 12006: 12009: 12010: 22011: 12012: 32013: 12014: 42015: 42016: 22017: 32018: 42019: 22020: 32021: 52022: 32023: 22024: 12025: 22026: 3
1998high 5 (2021) · low 0 (2004)2026

Most influential descendants

Showing 5 of 57 · See all
  • K984532Cadplan Helios Option 6.0Varian Medical Systems, Inc. · 1999 · cites it directly27descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K884261Prowess 2000Small Systems Group, Inc.1989—
0 (this device)K940663Peacock PlanNomos Corp.1996—
+1K984532Cadplan Helios Option 6.0Varian Medical Systems, Inc.1999—
+1K993766Helax-TMS V 5.0 Radiation Therapy Treatment Planning SystemHelax AB1999—
+2K010682Helax-TMS V 5.1 Radiation Therapy Treatment Planning SystemMds Nordion2001—
+3K020971DCM 2.0Mds Nordion AB2002—
+4K130617RaystationRaysearch Laboratories AB20136

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199920
200010
200110
200220
200320
200510
200610
200910
201020
201110
201230
201310
201440
201540
201620
201730
201840
201920
202030
202150
202230
202320
202410
202520
202630
FIG. 1 — Lineage of K940663, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K884261Prowess 2000
Summary page 1
…inical Affairs NOMOS Corporation (NOMOS) 2593 Wexford Bayne Road Sewickley, PA 15143 (412)-934-5477 . Name of predicate device(s): 1.Small Systems Group: Prowess 2000, K884261/A/B 2.GE Target Series 2, K896353 3.University of Michigan/Scanditronix: Scandiplan K903403 . Classification: Radiation Therap…
Small Systems Group, Inc.1989—
*K896353GE Target Series 2
Summary page 1
…OMOS) 2593 Wexford Bayne Road Sewickley, PA 15143 (412)-934-5477 . Name of predicate device(s): 1.Small Systems Group: Prowess 2000, K884261/A/B 2.GE Target Series 2, K896353 3.University of Michigan/Scanditronix: Scandiplan K903403 . Classification: Radiation Therapy Simulation Systems were reviewed…
GE Medical Systems1989—
*K903403CT-Compatible Fletcher System Applicator
Summary page 1
…34-5477 . Name of predicate device(s): 1.Small Systems Group: Prowess 2000, K884261/A/B 2.GE Target Series 2, K896353 3.University of Michigan/Scanditronix: Scandiplan K903403 . Classification: Radiation Therapy Simulation Systems were reviewed by the Radiological Devices Classification Panel and place…
University of Michigan1990—
†K841997CT 9800General Electric Co.1984—
†K910859Computerized Tomography X-Ray SystemSiemens Medical Solutions USA, Inc.1991—

What descends from it? (57)

See all 57

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

NumberDeviceApplicantDecidedDescendants
K984532Cadplan Helios Option 6.0Varian Medical Systems, Inc.199927
K993766Helax-TMS V 5.0 Radiation Therapy Treatment Planning SystemHelax AB199924
K992434Itp, Model 1.0Nucletron Corp.200021
K972451Coregistration FunctionNomos Corp.19985
K032209Nomos Corvus 5.0MNomos Corp.20034
K041971Wimrt Module for Artp Planning SystemProdigm Group, Inc.20051
K032456ProwessProwess, Inc.20030

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, K984532 (Varian Medical Systems, Inc., 1999) has gone furthest, with 27 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

2007: 232008: 142009: 202010: 232011: 112012: 282013: 182014: 202015: 202016: 212017: 232018: 212019: 192020: 202021: 192022: 122023: 182024: 92025: 122026 (partial year): 14
2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007: 44 days median2008: 69 days median2009: 63 days median2010: 74 days median2011: 94 days median2012: 106 days median2013: 88 days median2014: 100 days median2015: 108 days median2016: 97 days median2017: 94 days median2018: 58 days median2019: 83 days median2020: 67 days median2021: 86 days median2022: 172 days median2023: 129 days median2024: 239 days median2025: 170 days median2026 (partial year): 120 days median
2007high 239 (2024) · low 44 (2007)2026

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

Recalls per year · IYE

1in 2025

2007: 782008: 492009: 222010: 272011: 732012: 202013: 112014: 142015: 82016: 72017: 72018: 72019: 22020: 42021: 52022: 32023: 72024: 12025: 12026 (partial year): 4
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

2007: 1552008: 1142009: 1742010: 2462011: 2802012: 1282013: 962014: 1242015: 1002016: 972017: 1252018: 852019: 912020: 742021: 682022: 662023: 1282024: 812025: 101
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007234478155
2008146949114
2009206322174
2010237427246
2011119473280
20122810620128
201318881196
20142010014124
2015201088100
20162197797
201723947125
20182158785
20191983291
20202067474
20211986568
202212172366
2023181297128
20249239181
2025121701101
2026141204—

What is it indicated for?

The indications for the NOMOS Peacock Plan are the same as those for the predicate devices with external beam radiation: Present a graphical display of the resultant dose distribution around a target which is based upon the size, shape and position of the radiation treatment fields.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K940663: Peacock Plan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940663

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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