510(k) · Cleared
ClearedBU-CAD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taihao Medical, Inc. · QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Cleared on Dec 21, 2021 as substantially equivalent to K181704 (Screenpoint Medical B.V., 2018) and 1 other predicate after a 291-day review. Its family tree reaches back 12 generations to 1991. 3 later devices descend from it.
- Decided
- Dec 21, 2021
- Review
- 291 days
- Class
- Class II
- Product code
- QDQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K913770 (1991). 78 ancestors in all, the oldest K896095 (1990). 3 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations between
- 3 generations backK081556 Cadstream, Version 5.0Confirma, Inc. · 2009
- 2 generations backK092954 Cadstream Version 5Confirma, Inc. · 2009 · Recalled
- 1 generation backK170195 QuantXQuantitative Insights, Inc. · 2017
- This deviceK210670 BU-CADTaihao Medical, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK260086 CadAI-B DxBeamWorks, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK260303 See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK240697 See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd. · 2024
Show all 12 generations
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 11 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 10 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 9 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 8 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 7 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 6 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 5 generations backK052963 Mediq Version 1.0Clario Medical Imaging, Inc. · 2005
- 4 generations backK080196 Z3D Contrast AcuityClario Medical Imaging, Inc. · 2008
- 3 generations backK081556 Cadstream, Version 5.0Confirma, Inc. · 2009
- 2 generations backK092954 Cadstream Version 5Confirma, Inc. · 2009 · Recalled
- 1 generation backK170195 QuantXQuantitative Insights, Inc. · 2017
- This deviceK210670 BU-CADTaihao Medical, Inc. · 2021
Most influential descendants
Showing 3 of 3 · See all- K260086CadAI-B DxBeamWorks, Inc. · 2026 · cites it directly0descendants
- K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd. · 2026 · cites it directly0descendants
- K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −11 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −10 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −9 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −8 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −7 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −6 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −5 | K052963 | Mediq Version 1.0 | Clario Medical Imaging, Inc. | 2005 | — |
| −4 | K080196 | Z3D Contrast Acuity | Clario Medical Imaging, Inc. | 2008 | — |
| −3 | K081556 | Cadstream, Version 5.0 | Confirma, Inc. | 2009 | — |
| −2 | K092954 | Cadstream Version 5 | Confirma, Inc. | 2009 | 3 |
| −1 | K170195 | QuantX | Quantitative Insights, Inc. | 2017 | — |
| 0 (this device) | K210670 | BU-CAD | Taihao Medical, Inc. | 2021 | — |
| +1 | K260086 | CadAI-B Dx | BeamWorks, Inc. | 2026 | — |
| +1 | K260303 | See-Mode Augmented Reporting Tool, Breast (SMART-B) | See-Mode Technologies Pty, Ltd. | 2026 | — |
| +1 | 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 |
| 2018 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K181704 | TransparaSummary page 4…or Cancer Review Panel: Radiology Manufacturer: TaiHao Medical Inc. III. Predicate Device Predicate Device: TransparaTM (K181704) (primary), QuantX (K170195) Reference Device: Koios DS for Breast (K190442)… | 2018 |
| * | K170195 | QuantXSummary page 4…Radiology Manufacturer: TaiHao Medical Inc. III. Predicate Device Predicate Device: TransparaTM (K181704) (primary), QuantX (K170195) Reference Device: Koios DS for Breast (K190442) 1… | 2017 |
| † | K190442 | Koios DS for Breast | 2019 |
What descends from it? (3)
3 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)
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 30 years and passes through 8 companies; a new generation was cleared every 12 months on median.
- 18 of the 78 ancestors have a recall of any class.
- Of its descendants, K260086 (BeamWorks, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K181704.
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. 2021, 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?
BU-CAD is a software application indicated to assist trained 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 regions of interest (ROIs) and lesion contours placed on breast ultrasound images assisting physicians to identify suspicious soft tissue lesions from up to…
Read the full statement (221 words)
BU-CAD is a software application indicated to assist trained 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 regions of interest (ROIs) and lesion contours placed on breast ultrasound images assisting physicians to identify suspicious soft tissue lesions from up to two orthogonal views of a single lesion, and region-based analysis of lesion malignancy upon the physician's query. The region-based analysis indicates the score of lesion characteristics (SLC), and corresponding BI-RADS categories in user-selected ROIs or ROIs automatically identified by the software. In addition, BU-CAD also automatically classifies lesion shape, orientation, margin, echo pattern, and posterior features according to BI-RADS descriptors.
BU-CAD may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report (SR).
Patient management decisions should not be made solely on the basis of analysis by BU-CAD.
Limitations: BU-CAD is not to be used on sites of post-surgical excision, or images with Doppler, elastography, or other overlays present in them. BU-CAD is not intended for the primary interpretation of digital mammography images. BU-CAD is not intended for use on mobile devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210670 · printed Nov 5, 2026
Cite this page
510(k) Report. “K210670: BU-CAD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K210670
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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