510(k) · Cleared
ClearedB-Cad System, Version 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Medipattern Corporation · LLZ System, Image Processing, Radiological
Cleared on May 26, 2005 as substantially equivalent to K043216 (Confirma, Inc., 2005) and 3 other predicates after a 52-day review. Its family tree reaches back 5 generations to 1991. 123 later devices descend from it.
- Decided
- May 26, 2005
- Review
- 52 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K913770 (1991). 11 ancestors in all. 123 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 4 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 3 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 2 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 1 generation backK043216 Cadstream Version 4.0Confirma, Inc. · 2005
- This deviceK050846 B-Cad System, Version 1.0The Medipattern Corporation · 2005
- Descendant · cites it directly · 101 of its ownK141620 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- Descendant · 2 generations on · 99 of its ownK143089 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- Descendant · 2 generations on · 98 of its ownK143264 H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- Descendant · 3 generations on · 97 of its ownK150478 A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- Descendant · 2 generations on · 96 of its ownK151663 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
Showing 5 of 123 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 123 · See all- K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014 · cites it directly101descendants
- K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014 · 2 generations on99descendants
- K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014 · 2 generations on98descendants
- K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015 · 3 generations on97descendants
- K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015 · 2 generations on96descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −4 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −3 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −2 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −1 | K043216 | Cadstream Version 4.0 | Confirma, Inc. | 2005 | — |
| 0 (this device) | K050846 | B-Cad System, Version 1.0 | The Medipattern Corporation | 2005 | — |
| +1 | K141620 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| +2 | K143089 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| +2 | K143264 | H60 V2.00 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| +3 | K150478 | A35 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| +2 | K151663 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 10 | 0 |
| 2018 | 12 | 0 |
| 2019 | 12 | 0 |
| 2020 | 8 | 0 |
| 2021 | 13 | 0 |
| 2022 | 11 | 0 |
| 2023 | 8 | 0 |
| 2024 | 11 | 0 |
| 2025 | 12 | 0 |
| 2026 | 8 | 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? (4)
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 |
|---|---|---|---|
| * | K043216 | Cadstream Version 4.0Summary page 1…l device is substantially equivalent to the devices listed below: Model: CADstream Manufacturer: Confirma, Inc. 5 10(k) Number: K043216 Model: QLAB Software Manufacturer: Phillips Ultrasound 5 10(k) Numbers: K021966, K023877… | 2005 |
| * | K021966 | Q Lab SoftwareSummary page 1…Confirma, Inc. 5 10(k) Number: K043216 Model: QLAB Software Manufacturer: Phillips Ultrasound 5 10(k) Numbers: K021966, K023877 and K040227 4. Device Description: B-CAD is a computer-aided detection (CAD) software application, desi… | 2002 |
| * | K023877 | Q Lab Quantification Software with Strain Rate Quantification Plug-inSummary page 1…onfirma, Inc. 5 10(k) Number: K043216 Model: QLAB Software Manufacturer: Phillips Ultrasound 5 10(k) Numbers: K021966, K023877 and K040227 4. Device Description: B-CAD is a computer-aided detection (CAD) software application, designed to a… | 2002 |
| * | K040227 | Qlab Quantification SoftwareSummary page 1…. 5 10(k) Number: K043216 Model: QLAB Software Manufacturer: Phillips Ultrasound 5 10(k) Numbers: K021966, K023877 and K040227 4. Device Description: B-CAD is a computer-aided detection (CAD) software application, designed to assist radiol… | 2004 |
What descends from it? (123)
See all 1235 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 14 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K141620 (Samsung Medison Co., Ltd., 2014) has gone furthest, with 101 descendants of its own.
- 8 other devices also cite its predicate K043216.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
B-CAD is a computer-aided detection (CAD) software application designed to assist radiologists to analyze breast ultrasound images. B-CAD automatically segments and classifies shape and orientation characteristics of user-selected regions of interest (ROI). The software allows the user to annotate, tag, measure, and automatically record selected views. The software automatically generates reports from user inputs annotated during the image analysis…
Read the full statement (177 words)
B-CAD is a computer-aided detection (CAD) software application designed to assist radiologists to analyze breast ultrasound images. B-CAD automatically segments and classifies shape and orientation characteristics of user-selected regions of interest (ROI).
The software allows the user to annotate, tag, measure, and automatically record selected views. The software automatically generates reports from user inputs annotated during the image analysis process. An output may be viewed and sent to standard film or paper printers or sent electronically to an intranet web server or other DICOM device. The software may retrieve archived reports from a web server or other DICOM device.
B-CAD includes the option to add annotations based on the ACR-BI-RADS® Breast Imaging Atlas. In addition, the report form has been designed to support compliance with the ACR-BI-RADS® Ultrasound Lexicon Classification Form.
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 solely on the results of B-CAD analysis. The ultrasound images displayed on B-CAD must not be used for primary diagnostic interpretation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050846 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050846: B-Cad System, Version 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050846
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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