510(k) · Cleared
ClearedCoregistration Function
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nomos Corp. · IYE Accelerator, Linear, Medical
Cleared on Jan 22, 1998 as substantially equivalent to K960071 (Radionics Software Applications, Inc., 1996) and 1 other predicate after a 206-day review. Its family tree reaches back 2 generations to 1989. 5 later devices descend from it.
- Decided
- Jan 22, 1998
- Review
- 206 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K884261 (1989). 5 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK884261 Prowess 2000Small Systems Group, Inc. · 1989
- 1 generation backK940663 Peacock PlanNomos Corp. · 1996
- This deviceK972451 Coregistration FunctionNomos Corp. · 1998
- Descendant · cites it directly · 4 of its ownK032209 Nomos Corvus 5.0MNomos Corp. · 2003
- Descendant · 2 generations on · 3 of its ownK100092 Corvus Radiation Therapy Planning SystemBest Nomos · 2010
- Descendant · 3 generations on · 2 of its ownK151469 CORVUS Radiation Therapy Planning SystemBest Nomos · 2015
- Descendant · 4 generations on · 1 of its ownK201350 CorvusBest Nomos · 2020
- Descendant · 5 generations on · 0 of its ownK211034 Corvus Radiation Therapy Planning SystemBest Nomos · 2021
Most influential descendants
Showing 5 of 5 · See all- K032209Nomos Corvus 5.0MNomos Corp. · 2003 · cites it directly4descendants
- K100092Corvus Radiation Therapy Planning SystemBest Nomos · 2010 · 2 generations on3descendants
- K151469CORVUS Radiation Therapy Planning SystemBest Nomos · 2015 · 3 generations on2descendants
- K201350CorvusBest Nomos · 2020 · 4 generations on1descendant
- K211034Corvus Radiation Therapy Planning SystemBest Nomos · 2021 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K884261 | Prowess 2000 | Small Systems Group, Inc. | 1989 | — |
| −1 | K940663 | Peacock Plan | Nomos Corp. | 1996 | — |
| 0 (this device) | K972451 | Coregistration Function | Nomos Corp. | 1998 | — |
| +1 | K032209 | Nomos Corvus 5.0M | Nomos Corp. | 2003 | — |
| +2 | K100092 | Corvus Radiation Therapy Planning System | Best Nomos | 2010 | — |
| +3 | K151469 | CORVUS Radiation Therapy Planning System | Best Nomos | 2015 | — |
| +4 | K201350 | Corvus | Best Nomos | 2020 | — |
| +5 | K211034 | Corvus Radiation Therapy Planning System | Best Nomos | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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 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 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K960071 | ImagefusionSummary page 1…ction Applicant Name and Address l;sog(ewse%%%ogaat}i’%ré Road Sewickley, PA 15143 Name of Predicate Devices ImageFusion - Radionics Software Applications (RSA), Inc. (K960071)' Classification CORVUS™ (Cleared as PEACOCK® Plan (K940663) is classified as class II devices according to 21 CFR 882.5050 (90… | 1996 |
| * | K940663 | Peacock PlanSummary page 1…d Sewickley, PA 15143 Name of Predicate Devices ImageFusion - Radionics Software Applications (RSA), Inc. (K960071)' Classification CORVUS™ (Cleared as PEACOCK® Plan (K940663) is classified as class II devices according to 21 CFR 882.5050 (90 IYE). These devices are reviewed by the Radiological Devices… | 1996 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032209 | Nomos Corvus 5.0M | 2003 | 4 |
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 9 years and passes through 2 companies; a new generation was cleared every 6.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K032209 (Nomos Corp., 2003) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K960071.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
The Coregistration function is intended for use as part of an RT planning system (such as CORVUS) in procedures which could benefit from the ability to correlate between multiple image sets regardless of the modality used for scanning. In addition this function may be used to coregister earlier patient scans without a localization system.
The Coregistration function enables the use of complementary image data while maintaining the geometric accuracy and tissue density information from the CT.
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/K972451 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972451: Coregistration Function.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972451
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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