510(k) · Cleared
ClearedKoios DS for Breast
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Koios Medical, Inc. · POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Cleared on Jul 3, 2019 as substantially equivalent to DEN170022 (Quantitative Insights, Inc., 2017) and 1 other predicate after a 128-day review. Its family tree reaches back 7 generations to 1991. 12 later devices descend from it.
- Decided
- Jul 3, 2019
- Review
- 128 days
- Class
- Class II
- Product code
- POK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K913770 (1991). 14 ancestors in all. 12 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 5 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 4 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 3 generations backK043216 Cadstream Version 4.0Confirma, Inc. · 2005
- 2 generations backK050846 B-Cad System, Version 1.0The Medipattern Corporation · 2005
- 1 generation backK161959 ClearView cCADClearview Diagnostics, Inc. · 2016 · Recalled
- This deviceK190442 Koios DS for BreastKoios Medical, Inc. · 2019
- Descendant · cites it directly · 6 of its ownK201555 EchoGo ProUltromics, Ltd. · 2020
- Descendant · cites it directly · 4 of its ownK212616 Koios DSKoios Medical, Inc. · 2021
- Descendant · 2 generations on · 2 of its ownK242342 Fetal EchoScanBrightheart · 2024
- Descendant · 3 generations on · 1 of its ownK251071 Fetal EchoScan (v1.1)Brightheart · 2025
- Descendant · 2 generations on · 1 of its ownK243614 Sonio SuspectSonio · 2025
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K201555EchoGo ProUltromics, Ltd. · 2020 · cites it directly6descendants
- K212616Koios DSKoios Medical, Inc. · 2021 · cites it directly4descendants
- K242342Fetal EchoScanBrightheart · 2024 · 2 generations on2descendants
- K251071Fetal EchoScan (v1.1)Brightheart · 2025 · 3 generations on1descendant
- K243614Sonio SuspectSonio · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −6 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −5 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −4 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −3 | K043216 | Cadstream Version 4.0 | Confirma, Inc. | 2005 | — |
| −2 | K050846 | B-Cad System, Version 1.0 | The Medipattern Corporation | 2005 | — |
| −1 | K161959 | ClearView cCAD | Clearview Diagnostics, Inc. | 2016 | 1 |
| 0 (this device) | K190442 | Koios DS for Breast | Koios Medical, Inc. | 2019 | — |
| +1 | K201555 | EchoGo Pro | Ultromics, Ltd. | 2020 | — |
| +1 | K212616 | Koios DS | Koios Medical, Inc. | 2021 | — |
| +2 | K242342 | Fetal EchoScan | Brightheart | 2024 | — |
| +3 | K251071 | Fetal EchoScan (v1.1) | Brightheart | 2025 | — |
| +2 | K243614 | Sonio Suspect | Sonio | 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 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 POK? 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 POK device
- #1 K242342 Fetal EchoScanscore 16.7 · 9 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 |
|---|---|---|---|
| * | DEN170022 | QuantXSummary page 4…erformance, this software medical device is substantially equivalent to the devices listed below: Model: QuantX Manufacturer: Quantitative Insights, Inc. 510(k) Number: DEN170022 510(k) Summary Koios Medical, Inc. 5-1… | 2017 |
| * | K161959 | ClearView cCADSummary page 5…ical, Inc. 5-1 Model: ClearView cCAD, Version 1.0 Manufacturer: ClearView Diagnostics, Inc. 510(k) Number: K161959 4. Device Description Koios Decision Support (DS) for Breast is a software application designed to assist trained interpreting p… | 2016 |
What descends from it? (12)
See all 122 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 28 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 14 ancestors have a recall of any class.
- Of its descendants, K201555 (Ultromics, Ltd., 2020) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate DEN170022.
How does its category compare?
All POK devicesPOK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · POK
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · POK
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · POK
No recall names POK since 2007.
Adverse event reports per year · POK
1in 2021
MAUDE reports naming product code POK, 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 | 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 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 6 | 161 | 0 | 0 |
| 2025 | 5 | 119 | 0 | 0 |
| 2026 | 5 | 155 | 0 | — |
What is it indicated for?
Koios Decision Support (DS) for Breast is a software application designed to assist trained interpreting physicians in analyzing the breast ultrasound images of patients with soft tissue breast lesions who are being referred for further diagnostic ultrasound examination. Koios DS for Breast is a machine learning-based decision support system, indicated as an adjunct to diagnostic ultrasound for breast cancer. Koios DS for Breast automatically classifies…
Read the full statement (298 words)
Koios Decision Support (DS) for Breast is a software application designed to assist trained interpreting physicians in analyzing the breast ultrasound images of patients with soft tissue breast lesions who are being referred for further diagnostic ultrasound examination. Koios DS for Breast is a machine learning-based decision support system, indicated as an adjunct to diagnostic ultrasound for breast cancer. Koios DS for Breast automatically classifies user-selected region(s) of interest (ROIs) containing a breast lesion into four BI-RADS-aligned categories (Benign, Probably Benign, Suspicious, Probably Malignant), and displays a continuous graphical confidence level indicator of where the lesion falls across all categories. Koios DS for Breast also automatically classifies lesion shape and orientation according to BI-RADS descriptors.
The software requires a user to select up to two ROIs, from up to two orthogonal views, that represent a single lesion to be selected and processed. When utilized by an interpreting physician who has completed the prescribed training, this device provides information that may be useful in rendering an accurate diagnosis. Patient management decisions should not be made solely on the results of the Koios DS for Breast analysis. This device is intended to help trained interpreting physicians improve their overall accuracy as well as reduce inter- and intra-operator variability.
Koios DS for Breast 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.
Limitations: Koios DS for Breast is not to be used on sites of post-surgical excision, or images with doppler, elastography, or other overlays present in them. Koios DS for Breast is not intended for the primary interpretation of digital mammography images. Koios DS for Breast is not intended for use on mobile devices.
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/K190442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190442: Koios DS for Breast.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190442
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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