510(k) · Cleared
ClearedCorvus Radiation Therapy Planning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Best Nomos · MUJ System, Planning, Radiation Therapy Treatment
Cleared on May 6, 2021 as substantially equivalent to K201350 (Best Nomos, 2020) after a 29-day review. Its family tree reaches back 7 generations to 1989.
- Decided
- May 6, 2021
- Review
- 29 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K884261 (1989). 13 ancestors in all, the oldest K802809 (1981). No later device cites it as a predicate yet.
- Root · 7 generations backK884261 Prowess 2000Small Systems Group, Inc. · 1989
- 6 generations backK940663 Peacock PlanNomos Corp. · 1996
- 5 generations backK972451 Coregistration FunctionNomos Corp. · 1998
- 4 generations backK032209 Nomos Corvus 5.0MNomos Corp. · 2003
- 3 generations backK100092 Corvus Radiation Therapy Planning SystemBest Nomos · 2010
- 2 generations backK151469 CORVUS Radiation Therapy Planning SystemBest Nomos · 2015
- 1 generation backK201350 CorvusBest Nomos · 2020
- This deviceK211034 Corvus Radiation Therapy Planning SystemBest Nomos · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K884261 | Prowess 2000 | Small Systems Group, Inc. | 1989 | — |
| −6 | K940663 | Peacock Plan | Nomos Corp. | 1996 | — |
| −5 | K972451 | Coregistration Function | Nomos Corp. | 1998 | — |
| −4 | K032209 | Nomos Corvus 5.0M | Nomos Corp. | 2003 | — |
| −3 | K100092 | Corvus Radiation Therapy Planning System | Best Nomos | 2010 | — |
| −2 | K151469 | CORVUS Radiation Therapy Planning System | Best Nomos | 2015 | — |
| −1 | K201350 | Corvus | Best Nomos | 2020 | — |
| 0 (this device) | K211034 | Corvus Radiation Therapy Planning System | Best Nomos | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1996 | 2 | 0 |
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 K232799 syngo.via RT Image Suitescore 18.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K201350 | CorvusSummary page 5…DDLE EAST NORTH AMERICA healthcareforeveryone G. PREDICATE DEVICES CORVUS Radiation Therapy Treatment Planning System 14 (K201350) H. STATEMENT OF INDICATIONS FOR USE The intended use and indications for use for the CORVUS Radiation Therapy Treatment Pl… | 2020 |
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 32 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- None of the 13 ancestors has a recall.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, 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 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211034: 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/K211034
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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