510(k) · Cleared
ClearedcNeuro cDAT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Combinostics OY · LLZ System, Image Processing, Radiological
Cleared on Jul 1, 2024 as substantially equivalent to K201103 (GE Healthcare, 2020) after a 202-day review. Its family tree reaches back 11 generations to 2001.
- Decided
- Jul 1, 2024
- Review
- 202 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K010641 (2001). 24 ancestors in all, the oldest K914350 (1991). No later device cites it as a predicate yet.
- Root · 11 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 7 generations between
- 3 generations backK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
- 2 generations backK153355 Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016
- 1 generation backK201103 Xeleris V Processing and Review SystemsGE Healthcare · 2020
- This deviceK233908 cNeuro cDATCombinostics OY · 2024
Show all 11 generations
- Root · 11 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 10 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 9 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 8 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 7 generations backK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
- 6 generations backK061545 Scenium 1.1Siemens Molecular Imaging, Ltd. · 2006
- 5 generations backK121074 Scenium 2.0Siemens Medical Solutions USA, Inc. · 2012
- 4 generations backK123528 SceniumSiemens Medical Solutions USA, Inc. · 2012
- 3 generations backK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
- 2 generations backK153355 Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016
- 1 generation backK201103 Xeleris V Processing and Review SystemsGE Healthcare · 2020
- This deviceK233908 cNeuro cDATCombinostics OY · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −10 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −9 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −8 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −7 | K042863 | Scenium | Siemens Molecular Imaging, Ltd. | 2004 | — |
| −6 | K061545 | Scenium 1.1 | Siemens Molecular Imaging, Ltd. | 2006 | — |
| −5 | K121074 | Scenium 2.0 | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −4 | K123528 | Scenium | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −3 | K130884 | Xeleris 3.1 Processing and Review Workstation | Ge Medical Systems F.I. Haifa | 2013 | — |
| −2 | K153355 | Xeleris 4.0 Processing and Review Workstation | GE Healthcare | 2016 | — |
| −1 | K201103 | Xeleris V Processing and Review Systems | GE Healthcare | 2020 | — |
| 0 (this device) | K233908 | cNeuro cDAT | Combinostics OY | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K201103 | Xeleris V Processing and Review SystemsSummary page 4…e: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate Xeleris V Processing and Review Systems K201103 (DaTQUANT Application) / GE Medic… | 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 23 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 7 of the 24 ancestors have a recall of any class.
- 2 other devices also cite its predicate K201103.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
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?
cNeuro™ cDAT is intended for use by Nuclear Medicine or Radiology practitioners and referring physicians for display, processing, and reporting of Nuclear Medicine Imaging data. cNeuro™ cDAT enables visual evaluation and quantification of ioflupane I 123 (DaTscan™) images. The software enables automated quantification of tracer uptake and comparison with the corresponding tracer uptake in healthy subjects as provided by normal population databases of…
Read the full statement (140 words)
cNeuro™ cDAT is intended for use by Nuclear Medicine or Radiology practitioners and referring physicians for display, processing, and reporting of Nuclear Medicine Imaging data.
cNeuro™ cDAT enables visual evaluation and quantification of ioflupane I 123 (DaTscan™) images. The software enables automated quantification of tracer uptake and comparison with the corresponding tracer uptake in healthy subjects as provided by normal population databases of ioflupane I 123 (DaTscan™) images. cNeuro™ cDAT assists in detection of loss of functional dopaminergic neuron terminals in the striatum, which is correlated with Parkinson disease or Dementia with Lewy Bodies (DLB).
cNeuro™ cDAT has not been demonstrated to improve ioflupane I 123 reader performance for distinguishing positive from negative patients. This device should not be used to deviate from ioflupane I 123 dosing and administration instructions. Refer also to ioflupane I 123 prescribing information for instructions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233908 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233908: cNeuro cDAT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233908
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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