510(k) · Cleared
ClearedNomos Corvus 5.0M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nomos Corp. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Aug 21, 2003 as substantially equivalent to K940663 (Nomos Corp., 1996) and 2 other predicates after a 34-day review. Its family tree reaches back 3 generations to 1989. 4 later devices descend from it.
- Decided
- Aug 21, 2003
- Review
- 34 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K884261 (1989). 9 ancestors in all, the oldest K802809 (1981). 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK884261 Prowess 2000Small Systems Group, Inc. · 1989
- 2 generations backK940663 Peacock PlanNomos Corp. · 1996
- 1 generation backK972451 Coregistration FunctionNomos Corp. · 1998
- This deviceK032209 Nomos Corvus 5.0MNomos Corp. · 2003
- Descendant · cites it directly · 3 of its ownK100092 Corvus Radiation Therapy Planning SystemBest Nomos · 2010
- Descendant · 2 generations on · 2 of its ownK151469 CORVUS Radiation Therapy Planning SystemBest Nomos · 2015
- Descendant · 3 generations on · 1 of its ownK201350 CorvusBest Nomos · 2020
- Descendant · 4 generations on · 0 of its ownK211034 Corvus Radiation Therapy Planning SystemBest Nomos · 2021
Most influential descendants
Showing 4 of 4 · See all- K100092Corvus Radiation Therapy Planning SystemBest Nomos · 2010 · cites it directly3descendants
- K151469CORVUS Radiation Therapy Planning SystemBest Nomos · 2015 · 2 generations on2descendants
- K201350CorvusBest Nomos · 2020 · 3 generations on1descendant
- K211034Corvus Radiation Therapy Planning SystemBest Nomos · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K884261 | Prowess 2000 | Small Systems Group, Inc. | 1989 | — |
| −2 | K940663 | Peacock Plan | Nomos Corp. | 1996 | — |
| −1 | K972451 | Coregistration Function | Nomos Corp. | 1998 | — |
| 0 (this device) | K032209 | Nomos Corvus 5.0M | Nomos Corp. | 2003 | — |
| +1 | K100092 | Corvus Radiation Therapy Planning System | Best Nomos | 2010 | — |
| +2 | K151469 | CORVUS Radiation Therapy Planning System | Best Nomos | 2015 | — |
| +3 | K201350 | Corvus | Best Nomos | 2020 | — |
| +4 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K940663 | Peacock PlanSummary page 1…724-74 1-0778 Email: [email protected] B. Name of predicate device: NOMOS CORVUS System (K940663, K963258, K972451) C. Classification: Class I I D. Performance Standar… | 1996 |
| * | K963258 | Peacock SystemSummary page 1…Email: [email protected] B. Name of predicate device: NOMOS CORVUS System (K940663, K963258, K972451) C. Classification: Class I I D. Performance Standards: None established E. Intended U… | 1996 |
| * | K972451 | Coregistration FunctionSummary page 1…Email: [email protected] B. Name of predicate device: NOMOS CORVUS System (K940663, K963258, K972451) C. Classification: Class I I D. Performance Standards: None established E. Intended Use and De… | 1998 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100092 | Corvus Radiation Therapy Planning System | 2010 | 3 |
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 14 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K100092 (Best Nomos, 2010) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K940663.
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.
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 indications for use for the CORVUS Radiation Therapy Planning System have not changed as a result of this modification. 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) external beam radiation therapy. The treatment plans generated by CORVUS are based upon treatment machine-specific data and are intended to…
Read the full statement (109 words)
The indications for use for the CORVUS Radiation Therapy Planning System have not changed as a result of this modification.
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) 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 intracavitary sources (Brachytherapy) are not supported.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032209 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032209: Nomos Corvus 5.0M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032209
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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