510(k) Report

510(k) · Cleared

Cleared

Corvus Radiation Therapy Planning System

K100092510(k) SpecialCleared Feb 23, 201041-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

Best Nomos · MUJ System, Planning, Radiation Therapy Treatment

Cleared on Feb 23, 2010 as substantially equivalent to K032209 (Nomos Corp., 2003) after a 41-day review. Its family tree reaches back 4 generations to 1989. 3 later devices descend from it.

Decided
Feb 23, 2010
Review
41 days
Class
Class II
Product code
MUJ
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K884261 (1989). 10 ancestors in all, the oldest K802809 (1981). 3 later devices descend from it, 1 citing it directly.

Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 5 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant K032209 · Nomos Corvus 5.0M · Nomos Corp. · 2003K972451 · Coregistration Function · Nomos Corp. · 1998K940663 · Peacock Plan · Nomos Corp. · 1996K884261 · Prowess 2000 · Small Systems Group, Inc. · 19890
  1. Root · 4 generations backK884261 Prowess 2000Small Systems Group, Inc. · 1989
  2. 3 generations backK940663 Peacock PlanNomos Corp. · 1996
  3. 2 generations backK972451 Coregistration FunctionNomos Corp. · 1998
  4. 1 generation backK032209 Nomos Corvus 5.0MNomos Corp. · 2003
  5. This deviceK100092 Corvus Radiation Therapy Planning SystemBest Nomos · 2010
  6. Descendant · cites it directly · 2 of its ownK151469 CORVUS Radiation Therapy Planning SystemBest Nomos · 2015
  7. Descendant · 2 generations on · 1 of its ownK201350 CorvusBest Nomos · 2020
  8. Descendant · 3 generations on · 0 of its ownK211034 Corvus Radiation Therapy Planning SystemBest Nomos · 2021

Most influential descendants

Showing 3 of 3 · See all
  • K151469CORVUS Radiation Therapy Planning SystemBest Nomos · 2015 · cites it directly2descendants
  • K201350CorvusBest Nomos · 2020 · 2 generations on1descendant
  • K211034Corvus Radiation Therapy Planning SystemBest Nomos · 2021 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K884261Prowess 2000Small Systems Group, Inc.1989—
−3K940663Peacock PlanNomos Corp.1996—
−2K972451Coregistration FunctionNomos Corp.1998—
−1K032209Nomos Corvus 5.0MNomos Corp.2003—
0 (this device)K100092Corvus Radiation Therapy Planning SystemBest Nomos2010—
+1K151469CORVUS Radiation Therapy Planning SystemBest Nomos2015—
+2K201350CorvusBest Nomos2020—
+3K211034Corvus Radiation Therapy Planning SystemBest Nomos2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198610
198910
199010
199620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
202010
202110
FIG. 1 — Lineage of K100092, 1989–2021Source: 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 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. #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 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? (1)

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
*K032209Nomos Corvus 5.0M
Summary page 3
…tructures. Each structure can have a separate dose prescription. 2.10 PREDICATE DEVICE INFORMATION The CORVUS 09 system is substantially equivalent to the CORVUS 5.0M (K032209). The CORVUS 5.0M was determined to be substantially equivalent to its predicate device as of August 2003.. ) o - The fundamenta…
Nomos Corp.2003—
†K060859Compound W Freeze Off Wart Removal SystemOraSure Technologies, Inc.2006—
†K940412Multileaf Intensity Modulating CollimatorNomos Corp.1995—
†K013036Nomos Motorized Crane IINomos Corp.2001—

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K151469CORVUS Radiation Therapy Planning SystemBest Nomos20152

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 21 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
  • None of the 10 ancestors has a recall.
  • Of its descendants, K151469 (Best Nomos, 2015) has gone furthest, with 2 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. 2010, this device’s year, is highlighted.

FDA decisions per year · MUJ

10in 2025

2007: 42008: 92009: 162010: 112011: 92012: 82013: 52014: 92015: 132016: 52017: 72018: 72019: 92020: 92021: 112022: 82023: 102024: 92025: 102026 (partial year): 9
2007high 16 (2009) · low 4 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MUJ

186in 2025

2007: 67 days median2008: 63 days median2009: 84 days median2010: 56 days median2011: 103 days median2012: 59 days median2013: 64 days median2014: 108 days median2015: 78 days median2016: 80 days median2017: 30 days median2018: 53 days median2019: 56 days median2020: 104 days median2021: 87 days median2022: 168 days median2023: 140 days median2024: 122 days median2025: 186 days median2026 (partial year): 233 days median
2007high 233 (2026) · low 30 (2017)2026

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

Recalls per year · MUJ

2in 2023

2007: 42008: 102009: 112010: 232011: 172012: 42013: 62014: 22015: 72016: 132017: 42018: 32019: 42020: 22021: 42022: 32023: 22026 (partial year): 2
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

2007: 242008: 512009: 242010: 782011: 732012: 392013: 332014: 352015: 302016: 272017: 162018: 252019: 252020: 262021: 152022: 222023: 762024: 92025: 21
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007467424
20089631051
200916841124
201011562378
201191031773
2012859439
2013564633
20149108235
20151378730
20165801327
2017730416
2018753325
2019956425
20209104226
20211187415
20228168322
202310140276
2024912209
202510186021
202692332—

What is it indicated for?

The CORVUS system is a radiation treatment planning package designed to allow medical physxclsts, dosimetrists, and radiation oncologists to create conformal treatment plans using photon (x-ray) external beam radiation therapy. The treatment plans generated by CORVUS are based upon treatment machine-specific data and are intended to provide a guide to delivering external beam radiation therapy which conforms to the target volume defined by the radiation oncologist.

The CORVUS system is valid for use only with external beam photon therapy; calculations for electrons and intracavity sources (Brachytherapy) are NOT supported.

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. “K100092: Corvus Radiation Therapy Planning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100092

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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