510(k) · Cleared
ClearedCadAI-B Dx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BeamWorks, Inc. · QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Cleared on Aug 12, 2026 as substantially equivalent to K210670 (Taihao Medical, Inc., 2021) after a 212-day review. Its family tree reaches back 13 generations to 1991.
- Decided
- Aug 12, 2026
- Review
- 212 days
- Class
- Class II
- Product code
- QDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K913770 (1991). 79 ancestors in all, the oldest K896095 (1990). No later device cites it as a predicate yet.
- Root · 13 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations between
- 3 generations backK092954 Cadstream Version 5Confirma, Inc. · 2009 · Recalled
- 2 generations backK170195 QuantXQuantitative Insights, Inc. · 2017
- 1 generation backK210670 BU-CADTaihao Medical, Inc. · 2021
- This deviceK260086 CadAI-B DxBeamWorks, Inc. · 2026
Show all 13 generations
- Root · 13 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 12 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 11 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 10 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 9 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 8 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 7 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 6 generations backK052963 Mediq Version 1.0Clario Medical Imaging, Inc. · 2005
- 5 generations backK080196 Z3D Contrast AcuityClario Medical Imaging, Inc. · 2008
- 4 generations backK081556 Cadstream, Version 5.0Confirma, Inc. · 2009
- 3 generations backK092954 Cadstream Version 5Confirma, Inc. · 2009 · Recalled
- 2 generations backK170195 QuantXQuantitative Insights, Inc. · 2017
- 1 generation backK210670 BU-CADTaihao Medical, Inc. · 2021
- This deviceK260086 CadAI-B DxBeamWorks, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −12 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −11 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −10 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −9 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −8 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −7 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −6 | K052963 | Mediq Version 1.0 | Clario Medical Imaging, Inc. | 2005 | — |
| −5 | K080196 | Z3D Contrast Acuity | Clario Medical Imaging, Inc. | 2008 | — |
| −4 | K081556 | Cadstream, Version 5.0 | Confirma, Inc. | 2009 | — |
| −3 | K092954 | Cadstream Version 5 | Confirma, Inc. | 2009 | 3 |
| −2 | K170195 | QuantX | Quantitative Insights, Inc. | 2017 | — |
| −1 | K210670 | BU-CAD | Taihao Medical, Inc. | 2021 | — |
| 0 (this device) | 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 |
| 2018 | 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 QDQ? 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 QDQ device
- #1 K241831 Transpara (2.1.0)score 15.6 · 5 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 |
|---|---|---|---|
| * | K210670 | BU-CADSummary page 6…Page 6 === 4. Identification of Predicate Device(s) The identified predicate device within this submission is shown as follows; 510(k) Number K210670 Trade/Device/Model Name BU-CAD Product Name BU-CAD Regulation Name… | 2021 |
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 35 years and passes through 9 companies; a new generation was cleared every 12 months on median.
- 18 of the 79 ancestors have a recall of any class.
- 2 other devices also cite its predicate K210670.
How does its category compare?
All QDQ devicesQDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QDQ
10so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QDQ
216in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QDQ
No recall names QDQ since 2007.
Adverse event reports per year · QDQ
No MAUDE report names QDQ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 3 | 173 | 0 | 0 |
| 2021 | 5 | 169 | 0 | 0 |
| 2022 | 4 | 131 | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 7 | 153 | 0 | 0 |
| 2025 | 5 | 216 | 0 | 0 |
| 2026 | 10 | 154 | 0 | — |
What is it indicated for?
CadAI-B Dx is a software application indicated to assist interpreting physicians in analyzing the breast ultrasound images of patients with soft tissue breast lesions suspicious for breast cancer who are being referred for further diagnostic ultrasound examination. Output of the device includes lesion indicators placed on breast ultrasound images assisting physicians to identify suspicious soft tissue breast lesions from given B-Mode ultrasound images…
Read the full statement (178 words)
CadAI-B Dx is a software application indicated to assist interpreting physicians in analyzing the breast ultrasound images of patients with soft tissue breast lesions suspicious for breast cancer who are being referred for further diagnostic ultrasound examination.
Output of the device includes lesion indicators placed on breast ultrasound images assisting physicians to identify suspicious soft tissue breast lesions from given B-Mode ultrasound images and the risk analysis of malignancy. The risk analysis of malignancy indicates the malignancy score (CadAI-Score) and corresponding BI-RADS categories. In addition, CadAI-B Dx analyzes the size of the lesions and BI-RADS lexicon descriptors: shape, orientation, margin, echo pattern, and posterior features.
CadAI-B Dx may also be used as an image viewer of digital ultrasound images. The software includes tools that allow users to adjust, measure and document images, and output into a structured report.
Patient management decisions should not be made solely on the basis of analysis by CadAI-B Dx.
Limitations: CadAI-B Dx is not to be used on sites of post-surgical excision, or images with Doppler, elastography, or other overlays present in them.
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/K260086 · printed Nov 5, 2026
Cite this page
510(k) Report. “K260086: CadAI-B Dx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K260086
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026