510(k) · Cleared
Recalled · Class II · 2016Cadstream Version 5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Confirma, Inc. · LLZ System, Image Processing, Radiological
Cleared on Nov 6, 2009 as substantially equivalent to K081556 (Confirma, Inc., 2009) and 2 other predicates after a 42-day review. Its family tree reaches back 10 generations to 1991. 8 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 6, 2009
- Review
- 42 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 10 generations to K913770 (1991). 74 ancestors in all, the oldest K896095 (1990). 8 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations between
- 3 generations backK052963 Mediq Version 1.0Clario Medical Imaging, Inc. · 2005
- 2 generations backK080196 Z3D Contrast AcuityClario Medical Imaging, Inc. · 2008
- 1 generation backK081556 Cadstream, Version 5.0Confirma, Inc. · 2009
- This deviceK092954 Cadstream Version 5Confirma, Inc. · 2009
- Descendant · cites it directly · 4 of its ownK170195 QuantXQuantitative Insights, Inc. · 2017
- Descendant · 2 generations on · 3 of its ownK210670 BU-CADTaihao Medical, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK231130 TumorSight VizSimBioSys, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK243189 TumorSight VizSimBioSys, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK260086 CadAI-B DxBeamWorks, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 8 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 7 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 6 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 5 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 4 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 3 generations backK052963 Mediq Version 1.0Clario Medical Imaging, Inc. · 2005
- 2 generations backK080196 Z3D Contrast AcuityClario Medical Imaging, Inc. · 2008
- 1 generation backK081556 Cadstream, Version 5.0Confirma, Inc. · 2009
- This deviceK092954 Cadstream Version 5Confirma, Inc. · 2009
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K170195QuantXQuantitative Insights, Inc. · 2017 · cites it directly4descendants
- K210670BU-CADTaihao Medical, Inc. · 2021 · 2 generations on3descendants
- K231130TumorSight VizSimBioSys, Inc. · 2023 · cites it directly2descendants
- K243189TumorSight VizSimBioSys, Inc. · 2024 · 2 generations on1descendant
- K260086CadAI-B DxBeamWorks, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −9 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −8 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −7 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −6 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −5 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −4 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −3 | K052963 | Mediq Version 1.0 | Clario Medical Imaging, Inc. | 2005 | — |
| −2 | K080196 | Z3D Contrast Acuity | Clario Medical Imaging, Inc. | 2008 | — |
| −1 | K081556 | Cadstream, Version 5.0 | Confirma, Inc. | 2009 | — |
| 0 (this device) | K092954 | Cadstream Version 5 | Confirma, Inc. | 2009 | — |
| +1 | K170195 | QuantX | Quantitative Insights, Inc. | 2017 | — |
| +2 | K210670 | BU-CAD | Taihao Medical, Inc. | 2021 | — |
| +1 | K231130 | TumorSight Viz | SimBioSys, Inc. | 2023 | — |
| +2 | K243189 | TumorSight Viz | SimBioSys, Inc. | 2024 | — |
| +3 | K260086 | CadAI-B Dx | BeamWorks, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 11 | 0 |
| 2002 | 6 | 0 |
| 2003 | 7 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K081556 | Cadstream, Version 5.0Summary page 1…ot alter the fundamental scientific technology of the device. The primary predicate is therefore the previous clearance of CADstream 5 in K081556. Table 1 includes several additional predicate devices cleared with substantially equivalent ADC… | 2009 |
| * | K053301 | Cedara I-Response Cedara Pet/CTSummary page 1…de Classification Merge CAD Inc CADstream 5 K081556 ILLZ 2 Cedara I-Response K053301 LLZ Medtronic StealthViz K081512 LLZ 2 Merge CAD I… | 2006 |
| * | K081512 | Stealthviz Advanced Planning Application with Stealthdti PackageSummary page 1…6 ILLZ 2 Cedara I-Response K053301 LLZ Medtronic StealthViz K081512 LLZ 2 Merge CAD Inc CADstream 5 Special 510(k)… | 2008 |
What descends from it? (8)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 30, 2016 | Class II | Z-0137-2017 | Software design | The software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site starts using PURE filter, the user interface message will not display. This may result in incorrect patient follow-up. |
| Nov 1, 2012 | Class II | Z-2871-2016 | Error in labeling | An incorrect biopsy or missed target could result if the incorrect grid is selected within the application. |
| Oct 19, 2011 | Class II | Z-0118-2017 | Software design | Customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting in incorrect patient follow-up. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 17 of the 74 ancestors have a recall of any class.
- Of its descendants, K170195 (Quantitative Insights, Inc., 2017) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K081556.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
CADstream is intended to be used in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream supports evaluation of dynamic MR data acquired during contrast administration. CADstream performs other user selected processing functions (such as image registration, subtractions, measurements, 3D renderings, and reformats). CADstream also includes user-configurable features for reporting on findings in breast or…
Read the full statement (133 words)
CADstream is intended to be used in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream supports evaluation of dynamic MR data acquired during contrast administration. CADstream performs other user selected processing functions (such as image registration, subtractions, measurements, 3D renderings, and reformats).
CADstream also includes user-configurable features for reporting on findings in breast or general MRI studies. Additionally, CADstream assists users in planning MIM guided interventional procedures.
When interpreted by a skilled physician, this device provides information that may be used for screening, diagnosis, and interventional planning. Patient management decisions should not be made based solely on the results of CADstream.
CADstream may also be used as an image viewer of multi-modality, digital images, including ultrasound and mammography. CADstream is not intended for primary interpretation of digital mammography images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092954 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092954: Cadstream Version 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092954
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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