510(k) · Cleared
ClearedSee-Mode Augmented Reporting Tool, Breast (SMART-B)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
See-Mode Technologies Pty, Ltd. · QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Cleared on Jul 28, 2026 as substantially equivalent to K210670 (Taihao Medical, Inc., 2021) after a 179-day review. Its family tree reaches back 13 generations to 1991.
- Decided
- Jul 28, 2026
- Review
- 179 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 deviceK260303 See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd. · 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 deviceK260303 See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd. · 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) | K260303 | See-Mode Augmented Reporting Tool, Breast (SMART-B) | See-Mode Technologies Pty, Ltd. | 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 7…ment for patients. 6. PREDICATE DEVICE Manufacturer: TaiHao Medical Inc. Trade Name: BU-CAD 510(k) Identifier: K210670 Regulation Number: 21 CFR 892.2090 Regulation Name: Radiological Computer Assisted Detection/Diagnosis… | 2021 |
| † | K240697 | See-Mode Augmented Reporting Tool, Thyroid (SMART-T) | 2024 |
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?
See-Mode Augmented Reporting Tool, Breast (SMART-B) is a stand-alone software to assist trained interpreting physicians in analyzing the breast ultrasound images of patients with soft tissue breast lesions who are being referred for diagnostic ultrasound examination. Output of the device includes regions of interest (ROIs) placed on breast ultrasound images assisting interpreting physicians to localize suspicious soft tissue lesions from two orthogonal…
Read the full statement (158 words)
See-Mode Augmented Reporting Tool, Breast (SMART-B) is a stand-alone software to assist trained interpreting physicians in analyzing the breast ultrasound images of patients with soft tissue breast lesions who are being referred for diagnostic ultrasound examination.
Output of the device includes regions of interest (ROIs) placed on breast ultrasound images assisting interpreting physicians to localize suspicious soft tissue lesions from two orthogonal views of a single lesion in breast studies. The device also outputs the BI-RADS category as well as the ultrasonographic lexicon-based descriptors based on ACR BI-RADS for breast, including lesion shape, orientation, margin, echo pattern, and posterior features.
See-Mode Augmented Reporting Tool, Breast may also be used as a structured reporting software for further ultrasound studies. The software includes tools for reading measurements and annotations from the images that can be used for generating a structured report.
Patient management decisions should not be made solely on the basis of analysis by See-Mode Augmented Reporting Tool, Breast.
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/K260303 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260303: See-Mode Augmented Reporting Tool, Breast (SMART-B).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260303
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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