510(k) · Cleared
Recalled · Class II · 2019ClearView cCAD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clearview Diagnostics, Inc. · LLZ System, Image Processing, Radiological
Cleared on Dec 28, 2016 as substantially equivalent to K050846 (The Medipattern Corporation, 2005) after a 163-day review. Its family tree reaches back 6 generations to 1991. 13 later devices descend from it. It has been recalled once.
- Decided
- Dec 28, 2016
- Review
- 163 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K913770 (1991). 12 ancestors in all. 13 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 4 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 3 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 2 generations backK043216 Cadstream Version 4.0Confirma, Inc. · 2005
- 1 generation backK050846 B-Cad System, Version 1.0The Medipattern Corporation · 2005
- This deviceK161959 ClearView cCADClearview Diagnostics, Inc. · 2016
- Descendant · cites it directly · 12 of its ownK190442 Koios DS for BreastKoios Medical, Inc. · 2019
- Descendant · 2 generations on · 6 of its ownK201555 EchoGo ProUltromics, Ltd. · 2020
- Descendant · 2 generations on · 4 of its ownK212616 Koios DSKoios Medical, Inc. · 2021
- Descendant · 3 generations on · 2 of its ownK242342 Fetal EchoScanBrightheart · 2024
- Descendant · 4 generations on · 1 of its ownK251071 Fetal EchoScan (v1.1)Brightheart · 2025
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K190442Koios DS for BreastKoios Medical, Inc. · 2019 · cites it directly12descendants
- K201555EchoGo ProUltromics, Ltd. · 2020 · 2 generations on6descendants
- K212616Koios DSKoios Medical, Inc. · 2021 · 2 generations on4descendants
- K242342Fetal EchoScanBrightheart · 2024 · 3 generations on2descendants
- K251071Fetal EchoScan (v1.1)Brightheart · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −5 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −4 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −3 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −2 | K043216 | Cadstream Version 4.0 | Confirma, Inc. | 2005 | — |
| −1 | K050846 | B-Cad System, Version 1.0 | The Medipattern Corporation | 2005 | — |
| 0 (this device) | K161959 | ClearView cCAD | Clearview Diagnostics, Inc. | 2016 | — |
| +1 | K190442 | Koios DS for Breast | Koios Medical, Inc. | 2019 | — |
| +2 | K201555 | EchoGo Pro | Ultromics, Ltd. | 2020 | — |
| +2 | K212616 | Koios DS | Koios Medical, Inc. | 2021 | — |
| +3 | K242342 | Fetal EchoScan | Brightheart | 2024 | — |
| +4 | K251071 | Fetal EchoScan (v1.1) | Brightheart | 2025 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K050846 | B-Cad System, Version 1.0Summary page 4…ftware medical device is substantially equivalent to the device listed below: Model: B-CAD System, Version 1.0 Manufacturer: The Medipattern Corporation 510(k) Numbers: K050846 510(k) Summary ClearView Diagnostics, Inc. 5-1 4. Device D… | 2005 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190442 | Koios DS for Breast | 2019 | 12 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 31, 2019 | Class II | Z-0820-2020 | Other | Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedures. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 6 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K190442 (Koios Medical, Inc., 2019) has gone furthest, with 12 descendants of its own.
- 4 other devices also cite its predicate K050846.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
ClearView cCAD is a software application designed to assist skilled physicians in analyzing breast ultrasound images. ClearView cCAD automatically classifies shape and orientation characteristics of user-selected regions of interest (ROIs). The software allows the user to annotate, tag, measure, and automatically record and/or store selected views. The software also automatically generates reports from user inputs annotated during the image analysis…
Read the full statement (198 words)
ClearView cCAD is a software application designed to assist skilled physicians in analyzing breast ultrasound images. ClearView cCAD automatically classifies shape and orientation characteristics of user-selected regions of interest (ROIs).
The software allows the user to annotate, tag, measure, and automatically record and/or store selected views. The software also automatically generates reports from user inputs annotated during the image analysis process as well as the automatically generated characteristics. The output of this system will be a DICOM compatible (e.g. grayscale softcopy presentation state (GSPS)) and/or PDF report that can be sent along with the original image to standard film or paper printers or sent electronically to an intranet webserver or other DICOM compatible device.
cCAD includes options to annotate and describe the image 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 decision should not be made solely on the results of the cCAD analysis. The ultrasound images displayed on cCAD must not be used for primary diagnostic interpretation.
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/K161959 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161959: ClearView cCAD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161959
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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