510(k) · Cleared
ClearedZ3D Contrast Acuity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clario Medical Imaging, Inc. · LLZ System, Image Processing, Radiological
Cleared on Sep 5, 2008 as substantially equivalent to K052963 (Clario Medical Imaging, Inc., 2005) and 1 other predicate after a 224-day review. Its family tree reaches back 8 generations to 1991. 10 later devices descend from it.
- Decided
- Sep 5, 2008
- Review
- 224 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K913770 (1991). 46 ancestors in all, the oldest K896095 (1990). 10 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 6 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 5 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 4 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 3 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 2 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 1 generation backK052963 Mediq Version 1.0Clario Medical Imaging, Inc. · 2005
- This deviceK080196 Z3D Contrast AcuityClario Medical Imaging, Inc. · 2008
- Descendant · cites it directly · 9 of its ownK081556 Cadstream, Version 5.0Confirma, Inc. · 2009
- Descendant · 2 generations on · 8 of its ownK092954 Cadstream Version 5Confirma, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 4 of its ownK170195 QuantXQuantitative Insights, Inc. · 2017
- Descendant · 3 generations on · 3 of its ownK210670 BU-CADTaihao Medical, Inc. · 2021
- Descendant · 3 generations on · 2 of its ownK231130 TumorSight VizSimBioSys, Inc. · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K081556Cadstream, Version 5.0Confirma, Inc. · 2009 · cites it directly9descendants
- K092954Cadstream Version 5Confirma, Inc. · 2009 · 2 generations on8descendants
- K170195QuantXQuantitative Insights, Inc. · 2017 · 2 generations on4descendants
- K210670BU-CADTaihao Medical, Inc. · 2021 · 3 generations on3descendants
- K231130TumorSight VizSimBioSys, Inc. · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −7 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −6 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −5 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −4 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −3 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −2 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −1 | K052963 | Mediq Version 1.0 | Clario Medical Imaging, Inc. | 2005 | — |
| 0 (this device) | K080196 | Z3D Contrast Acuity | Clario Medical Imaging, Inc. | 2008 | — |
| +1 | K081556 | Cadstream, Version 5.0 | Confirma, Inc. | 2009 | — |
| +2 | K092954 | Cadstream Version 5 | Confirma, Inc. | 2009 | 3 |
| +2 | K170195 | QuantX | Quantitative Insights, Inc. | 2017 | — |
| +3 | K210670 | BU-CAD | Taihao Medical, Inc. | 2021 | — |
| +3 | K231130 | TumorSight Viz | SimBioSys, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 8 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K052963 | Mediq Version 1.0Summary page 4…d below: Model: MedIQ Manufacturer: Clario Medical Imagining, Inc. 510(k) Number: K052963 Model: CADstream Version 4.0 Manufacturer: Confirma, Inc.… | 2005 |
| * | K043216 | Cadstream Version 4.0Summary page 4…K052963 Model: CADstream Version 4.0 Manufacturer: Confirma, Inc. 510(k) Number: K043216 Original 510(k) PreMarket Notification Clarlo Medical Imaging, Inc. 16… | 2005 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081556 | Cadstream, Version 5.0 | 2009 | 9 |
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 17 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 11 of the 46 ancestors have a recall of any class.
- Of its descendants, K081556 (Confirma, Inc., 2009) has gone furthest, with 9 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. 2008, 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?
z3D Contrast Acuity (z3D) version 2.1 is a post-processing, productivity software package designed to assist radiologists in the analysis of dynamic CT and MR images. The software provides image display, supplemental information and visual enhancement of time/intensity changes extracted from CT and MR temporal datasets. Single or multi-slice datasets, using standard acquisition protocols, are used for input. The software displays the temporal variation…
Read the full statement (275 words)
z3D Contrast Acuity (z3D) version 2.1 is a post-processing, productivity software package designed to assist radiologists in the analysis of dynamic CT and MR images. The software provides image display, supplemental information and visual enhancement of time/intensity changes extracted from CT and MR temporal datasets. Single or multi-slice datasets, using standard acquisition protocols, are used for input.
The software displays the temporal variation in dynamic data as a surface map that enhances visualization of pixel intensity and time/intensity changes extracted from CT and MR temporal data sets. The results may be displayed as either a grayscale enhancement or a color overlay on the selected image.
z3D may perform additional functions to aid in the analysis and viewing of dynamic studies, including registration of serial MR and CT acquisitions, labeling of tissue types based upon user specified enhancement characteristics, visualization and quantification of lesion morphology in 3D, segmentation of tissues, multiplanar and oblique reformats, maximum intensity projections, image averaging, subtraction and blinking of images acquired at different time points to help visualize enhancement.
z3D also may be used to perform post-processing analysis of multi-modality, digital images, including MR, CT, X-Ray, PET, and Nuclear Medicine images. The software analysis tools may be applied to image subtractions, reformatted images, multiplanar reformats, and maximum intensity projections.
The software package includes tools to allow the radiologist to manipulate and fly-through images for enhanced visualization.
When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made based solely on the results of z3D analysis. The z3D software is contraindicated for automated sole interpretation of digital mammography images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080196: Z3D Contrast Acuity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080196
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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