510(k) Report

510(k) · Cleared

Cleared

CORVUS Radiation Therapy Planning System

K151469510(k) TraditionalCleared Nov 25, 2015177-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 Nov 25, 2015 as substantially equivalent to K100092 (Best Nomos, 2010) after a 177-day review. Its family tree reaches back 5 generations to 1989. 2 later devices descend from it.

Decided
Nov 25, 2015
Review
177 days
Class
Class II
Product code
MUJ
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K884261 (1989). 11 ancestors in all, the oldest K802809 (1981). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 2 other ancestors1990: 1 other ancestor1989: 1 other ancestor1986: 1 other ancestor1981: 1 other ancestor2020: 1 descendant cleared2021: 1 descendant clearedReference device: K102915 · Viewray Treatment Planning and Delivery System · Viewray, Incorporated · 2011 · recalledK884261 · Prowess 2000 · Small Systems Group, Inc. · 1989K940663 · Peacock Plan · Nomos Corp. · 1996K972451 · Coregistration Function · Nomos Corp. · 1998K032209 · Nomos Corvus 5.0M · Nomos Corp. · 2003K100092 · Corvus Radiation Therapy Planning System · Best Nomos · 201019801990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor4 generations back: 5 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K100092 · Corvus Radiation Therapy Planning System · Best Nomos · 2010K032209 · Nomos Corvus 5.0M · Nomos Corp. · 2003K972451 · Coregistration Function · Nomos Corp. · 1998K940663 · Peacock Plan · Nomos Corp. · 1996K884261 · Prowess 2000 · Small Systems Group, Inc. · 1989−50
  1. Root · 5 generations backK884261 Prowess 2000Small Systems Group, Inc. · 1989
  2. 4 generations backK940663 Peacock PlanNomos Corp. · 1996
  3. 3 generations backK972451 Coregistration FunctionNomos Corp. · 1998
  4. 2 generations backK032209 Nomos Corvus 5.0MNomos Corp. · 2003
  5. 1 generation backK100092 Corvus Radiation Therapy Planning SystemBest Nomos · 2010
  6. This deviceK151469 CORVUS Radiation Therapy Planning SystemBest Nomos · 2015
  7. Descendant · cites it directly · 1 of its ownK201350 CorvusBest Nomos · 2020
  8. Descendant · 2 generations on · 0 of its ownK211034 Corvus Radiation Therapy Planning SystemBest Nomos · 2021

Most influential descendants

Showing 2 of 2 · See all
  • K201350CorvusBest Nomos · 2020 · cites it directly1descendant
  • K211034Corvus Radiation Therapy Planning SystemBest Nomos · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K884261Prowess 2000Small Systems Group, Inc.1989—
−4K940663Peacock PlanNomos Corp.1996—
−3K972451Coregistration FunctionNomos Corp.1998—
−2K032209Nomos Corvus 5.0MNomos Corp.2003—
−1K100092Corvus Radiation Therapy Planning SystemBest Nomos2010—
0 (this device)K151469CORVUS Radiation Therapy Planning SystemBest Nomos2015—
+1K201350CorvusBest Nomos2020—
+2K211034Corvus 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
202010
202110
FIG. 1 — Lineage of K151469, 1989–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
Get a 510(k) Report

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
*K100092Corvus Radiation Therapy Planning System
Summary page 6
…have a separate dose prescription. K. PREDICATE DEVICE INFORMATION The CORVUS 2011 system is substantially equivalent to its primary predicate device CORVUS 09 (K100092). The ViewRay Treatment Planning and Delivery System (K102915) for treatment planning is used only as a reference predicate dev…
Best Nomos2010—
†K102915Viewray Treatment Planning and Delivery SystemViewray, Incorporated20111

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K201350CorvusBest Nomos20201

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 26 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
  • None of the 11 ancestors has a recall.
  • Of its descendants, K201350 (Best Nomos, 2020) has gone furthest, with 1 descendant 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. 2015, 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

physicists, dosimetrists, and radiation oncologists to create conformal treatment plans using

photon (x-ray, gamma 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 as stated in the FDA summary.

Cite this page

510(k) Report. “K151469: 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/K151469

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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