510(k) Report

510(k) · Cleared

Cleared

Raptor Treatment Planning System

K993359510(k) TraditionalCleared Dec 21, 199976-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 Dec 21, 1999 as substantially equivalent to K982791 (Radiation Oncology Computer Systems, 1998) and 2 other predicates after a 76-day review. Its family tree reaches back 2 generations to 1981.

Decided
Dec 21, 1999
Review
76 days
Class
Class II
Product code
IYE
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K802809 (1981). 12 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor1994: 2 other ancestors1992: 1 other ancestor1990: 1 other ancestor1989: 1 other ancestor1987: 1 other ancestor1986: 1 other ancestorK802809 · Electron Arc Therapy · Varian Assoc., Inc. · 1981K963258 · Peacock System · Nomos Corp. · 199619801985199019952000
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 8 other ancestors K963258 · Peacock System · Nomos Corp. · 1996K802809 · Electron Arc Therapy · Varian Assoc., Inc. · 19810
  1. Root · 2 generations backK802809 Electron Arc TherapyVarian Assoc., Inc. · 1981
  2. 1 generation backK963258 Peacock SystemNomos Corp. · 1996
  3. This deviceK993359 Raptor Treatment Planning SystemNomos Corp. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K802809Electron Arc TherapyVarian Assoc., Inc.1981—
−1K963258Peacock SystemNomos Corp.1996—
0 (this device)K993359Raptor Treatment Planning SystemNomos Corp.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198710
198910
199010
199210
199420
199610
199710
199810
FIG. 1 — Lineage of K993359, 1981–1999Source: 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
*K982791Rocs TPS
Summary page 1
…cation name: Accelerator, Linear, Medical, Accessory 90 IYE [21 CFR 892.5050] (a) (3) Predicate device: Radiation Oncology Computer Systems, Treatment Planning System K982791 Theratronics, TheraPlan Plus K970236 NOMOS Corporation, PEACOCK® System K963258 (a) (4) Device description: The RAPTOR Treatm…
Radiation Oncology Computer Systems1998—
*K970236Theraplan Plus Version 1.2
Summary page 1
…cal, Accessory 90 IYE [21 CFR 892.5050] (a) (3) Predicate device: Radiation Oncology Computer Systems, Treatment Planning System K982791 Theratronics, TheraPlan Plus K970236 NOMOS Corporation, PEACOCK® System K963258 (a) (4) Device description: The RAPTOR Treatment Planning System is a collection of…
Theratronics, Inc.1997—
*K963258Peacock System
Summary page 1
…) (3) Predicate device: Radiation Oncology Computer Systems, Treatment Planning System K982791 Theratronics, TheraPlan Plus K970236 NOMOS Corporation, PEACOCK® System K963258 (a) (4) Device description: The RAPTOR Treatment Planning System is a collection of software modules that execute known and doc…
Nomos Corp.1996—

What descends from it?

No later submission names this one as a predicate yet.

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 18 years and passes through 2 companies; a new generation was cleared every 15.9 years on median.
  • None of the 12 ancestors has a recall.

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 RAPTOR® Treatment Planning System is used to generate computation, display, evaluation and output radiation dose estimates for clinical review and judgement prior to treating the patient. It uses well-documented algorithms to provide output data in the form of displays, hardcopy prints, plots and treatment instructions to guide the radiation oncology professional and / or physician to select the optimum treatment plan. The MLC module is used to…

Read the full statement (104 words)

The RAPTOR® Treatment Planning System is used to generate computation, display,

evaluation and output radiation dose estimates for clinical review and judgement prior to

treating the patient. It uses well-documented algorithms to provide output data in the

form of displays, hardcopy prints, plots and treatment instructions to guide the radiation

oncology professional and / or physician to select the optimum treatment plan. The MLC

module is used to generate plans and instructions for documented and released

multileaf collimators. The RAPTOR® Treatment Planning System is intended to be used

by a competent health professional such as a radiation oncologist, medical physicist,

radiation therapist, or dosimetrist.

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

More from Nomos Corp.

21 FDA decisions under this applicant name. See the company

  • K070611Bat Ultrasound Localization and Positioning System, Version 6Nomos Corp. · 2007
  • K060895Nomosstat, Version 1.0Nomos Corp. · 2006
  • K042875NavigatorNomos Corp. · 2005
  • K032209Nomos Corvus 5.0MNomos Corp. · 2003
  • K013036Nomos Motorized Crane IINomos Corp. · 2001

Recent decisions in IYE

The IYE category page

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  • K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd. · 2026
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https://510kreport.com/device/K993359 · printed Nov 4, 2026

Cite this page

510(k) Report. “K993359: Raptor Treatment Planning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993359

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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