510(k) · Cleared
ClearedQuantX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantitative Insights, Inc. · LLZ System, Image Processing, Radiological
Cleared on May 17, 2017 as substantially equivalent to K081556 (Confirma, Inc., 2009) and 1 other predicate after a 114-day review. Its family tree reaches back 11 generations to 1991. 4 later devices descend from it.
- Decided
- May 17, 2017
- Review
- 114 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K913770 (1991). 75 ancestors in all, the oldest K896095 (1990). 4 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations between
- 3 generations backK080196 Z3D Contrast AcuityClario Medical Imaging, Inc. · 2008
- 2 generations backK081556 Cadstream, Version 5.0Confirma, Inc. · 2009
- 1 generation backK092954 Cadstream Version 5Confirma, Inc. · 2009 · Recalled
- This deviceK170195 QuantXQuantitative Insights, Inc. · 2017
- Descendant · cites it directly · 3 of its ownK210670 BU-CADTaihao Medical, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK260086 CadAI-B DxBeamWorks, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK260303 See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK240697 See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd. · 2024
Show all 11 generations
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 9 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 8 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 7 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 6 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 5 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 4 generations backK052963 Mediq Version 1.0Clario Medical Imaging, Inc. · 2005
- 3 generations backK080196 Z3D Contrast AcuityClario Medical Imaging, Inc. · 2008
- 2 generations backK081556 Cadstream, Version 5.0Confirma, Inc. · 2009
- 1 generation backK092954 Cadstream Version 5Confirma, Inc. · 2009 · Recalled
- This deviceK170195 QuantXQuantitative Insights, Inc. · 2017
Most influential descendants
Showing 4 of 4 · See all- K210670BU-CADTaihao Medical, Inc. · 2021 · cites it directly3descendants
- K260086CadAI-B DxBeamWorks, Inc. · 2026 · 2 generations on0descendants
- K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd. · 2026 · 2 generations on0descendants
- K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −10 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −9 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −8 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −7 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −6 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −5 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −4 | K052963 | Mediq Version 1.0 | Clario Medical Imaging, Inc. | 2005 | — |
| −3 | K080196 | Z3D Contrast Acuity | Clario Medical Imaging, Inc. | 2008 | — |
| −2 | K081556 | Cadstream, Version 5.0 | Confirma, Inc. | 2009 | — |
| −1 | K092954 | Cadstream Version 5 | Confirma, Inc. | 2009 | 3 |
| 0 (this device) | K170195 | QuantX | Quantitative Insights, Inc. | 2017 | — |
| +1 | K210670 | BU-CAD | Taihao Medical, Inc. | 2021 | — |
| +2 | K260086 | CadAI-B Dx | BeamWorks, Inc. | 2026 | — |
| +2 | K260303 | See-Mode Augmented Reporting Tool, Breast (SMART-B) | See-Mode Technologies Pty, Ltd. | 2026 | — |
| +2 | K240697 | See-Mode Augmented Reporting Tool, Thyroid (SMART-T) | See-Mode Technologies Pte, Ltd. | 2024 | — |
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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K081556 | Cadstream, Version 5.0Summary page 4…ame: Picture archiving and communications system Product Code: LLZ A. LEGALLY MARKETED PREDICATE DEVICE Legally marketed predicate device is: CADStream Version 5 - K081556, K092954 B. DEVICE DESCRIPTION QuantX is a software program that analyzes patient breast images, and is designed to aid rad… | 2009 |
| * | K092954 | Cadstream Version 5Summary page 4…ure archiving and communications system Product Code: LLZ A. LEGALLY MARKETED PREDICATE DEVICE Legally marketed predicate device is: CADStream Version 5 - K081556, K092954 B. DEVICE DESCRIPTION QuantX is a software program that analyzes patient breast images, and is designed to aid radiologists… | 2009 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210670 | BU-CAD | 2021 | 3 |
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 26 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 18 of the 75 ancestors have a recall of any class.
- Of its descendants, K210670 (Taihao Medical, Inc., 2021) has gone furthest, with 3 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. 2017, 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?
QuantX is a quantitative image analysis software device used to assist radiologists in the assessment and characterization of breast abnormalities using MR image data. The software automatically registers images, and segments and analyzes user-selected regions of interest (ROI). QuantX extracts image data from the ROI to provide volumetric and surface area analysis. These imaging features are then displayed to the user in a dedicated analysis panel on…
Read the full statement (151 words)
QuantX is a quantitative image analysis software device used to assist radiologists in the assessment and characterization of breast abnormalities using MR image data. The software automatically registers images, and segments and analyzes user-selected regions of interest (ROI). QuantX extracts image data from the ROI to provide volumetric and surface area analysis. These imaging features are then displayed to the user in a dedicated analysis panel on the display monitor.
When interpreted by a skilled physician, this device provides information that may be useful for screening and diagnosis. Patient management decisions should not be made based solely on the results of QuantX analysis.
QuantX may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software also includes tools that allow users to measure and document images, and output in a structured report.
Limitations: QuantX is not intended for primary interpretation of digital mammography images.
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/K170195 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170195: QuantX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170195
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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