510(k) · Cleared
ClearedImagefusion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radionics Software Applications, Inc. · LLZ System, Image Processing, Radiological
Cleared on Apr 17, 1996 after a 103-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Apr 17, 1996
- Review
- 103 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK960071 ImagefusionRadionics Software Applications, Inc. · 1996
- Descendant · cites it directly · 5 of its ownK972451 Coregistration FunctionNomos Corp. · 1998
- Descendant · 2 generations on · 4 of its ownK032209 Nomos Corvus 5.0MNomos Corp. · 2003
- Descendant · 3 generations on · 3 of its ownK100092 Corvus Radiation Therapy Planning SystemBest Nomos · 2010
- Descendant · 4 generations on · 2 of its ownK151469 CORVUS Radiation Therapy Planning SystemBest Nomos · 2015
- Descendant · 5 generations on · 1 of its ownK201350 CorvusBest Nomos · 2020
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K972451Coregistration FunctionNomos Corp. · 1998 · cites it directly5descendants
- K032209Nomos Corvus 5.0MNomos Corp. · 2003 · 2 generations on4descendants
- K100092Corvus Radiation Therapy Planning SystemBest Nomos · 2010 · 3 generations on3descendants
- K151469CORVUS Radiation Therapy Planning SystemBest Nomos · 2015 · 4 generations on2descendants
- K201350CorvusBest Nomos · 2020 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960071 | Imagefusion | Radionics Software Applications, Inc. | 1996 | — |
| +1 | K972451 | Coregistration Function | Nomos Corp. | 1998 | — |
| +2 | K032209 | Nomos Corvus 5.0M | Nomos Corp. | 2003 | — |
| +3 | K100092 | Corvus Radiation Therapy Planning System | Best Nomos | 2010 | — |
| +4 | K151469 | CORVUS Radiation Therapy Planning System | Best Nomos | 2015 | — |
| +5 | K201350 | Corvus | Best Nomos | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 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 |
|---|---|---|---|
| * | — | RSA StereoPlan Named without a submission number |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K972451 (Nomos Corp., 1998) has gone furthest, with 5 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
Image processing and comparing an MR and a CT image set or two different CT image sets.
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/K960071 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960071: Imagefusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960071
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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