510(k) · Cleared
ClearedKoios DS
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 Dec 16, 2021 as substantially equivalent to K190442 (Koios Medical, Inc., 2019) after a 120-day review. Its family tree reaches back 8 generations to 1991. 4 later devices descend from it.
- Decided
- Dec 16, 2021
- Review
- 120 days
- Class
- Class II
- Product code
- POK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K913770 (1991). 15 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 6 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 5 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 4 generations backK043216 Cadstream Version 4.0Confirma, Inc. · 2005
- 3 generations backK050846 B-Cad System, Version 1.0The Medipattern Corporation · 2005
- 2 generations backK161959 ClearView cCADClearview Diagnostics, Inc. · 2016 · Recalled
- 1 generation backK190442 Koios DS for BreastKoios Medical, Inc. · 2019
- This deviceK212616 Koios DSKoios Medical, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK243614 Sonio SuspectSonio · 2025
- Descendant · cites it directly · 1 of its ownK242130 Koios DSKoios Medical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK253884 Koios DS (3.8)Koios Medical, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK261519 Sonio SuspectSonio · 2026
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −7 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −6 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −5 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −4 | K043216 | Cadstream Version 4.0 | Confirma, Inc. | 2005 | — |
| −3 | K050846 | B-Cad System, Version 1.0 | The Medipattern Corporation | 2005 | — |
| −2 | K161959 | ClearView cCAD | Clearview Diagnostics, Inc. | 2016 | 1 |
| −1 | K190442 | Koios DS for Breast | Koios Medical, Inc. | 2019 | — |
| 0 (this device) | K212616 | Koios DS | Koios Medical, Inc. | 2021 | — |
| +1 | K243614 | Sonio Suspect | Sonio | 2025 | — |
| +1 | K242130 | Koios DS | Koios Medical, Inc. | 2024 | — |
| +2 | K253884 | Koios DS (3.8) | Koios Medical, Inc. | 2026 | — |
| +2 | K261519 | Sonio Suspect | Sonio | 2026 | — |
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 |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K190442 | Koios DS for BreastSummary page 5…the devices listed below: Model: Koios DS for Breast Manufacturer: Koios Medical, Inc. 510(k) Number: K190442 4. Device Description Koios DS is a software application designed to assist trained interpreting physicians in… | 2019 |
What descends from it? (4)
2 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 7 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K243614 (Sonio, 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K190442.
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. 2021, 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 DS is an artificial intelligence (Al)/machine learning (ML)-based computer-aided diagnosis (CADx) software device intended for use as an adjunct to diagnostic ultrasound examinations of lesions or nodules suspicious for breast or thyroid cancer. Koios DS allows the user to select or confirm regions of interest (ROIs) within an image representing a single lesion or nodule to be analyzed. The software then automatically characterizes the selected…
Read the full statement (310 words)
Koios DS is an artificial intelligence (Al)/machine learning (ML)-based computer-aided diagnosis (CADx) software device intended for use as an adjunct to diagnostic ultrasound examinations of lesions or nodules suspicious for breast or thyroid cancer.
Koios DS allows the user to select or confirm regions of interest (ROIs) within an image representing a single lesion or nodule to be analyzed. The software then automatically characterizes the selected image data to generate an AI/ML-derived cancer risk assessment and selects applicable lexicon-based descriptors designed to improve overall diagnostic accuracy as well as reduce interpreting physician variability.
Koios DS 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.
Koios DS software is designed to assist trained interpreting physicians in analyzing the breast ultrasound images of adult (>= 22 years) female patients with soft tissue breast lesions and/or thyroid ultrasounds of all adult (>= 22 years) patients with thyroid nodules suspicious for cancer. When utilized by an interpreting physician who has completed the prescribed training, this device provides information that may be useful in recommending appropriate clinical management.
Limitations:
» Patient management decisions should not be made solely on the results of the Koios DS analysis.
» Koios DS software is not to be used for the evaluation of normal tissue, on sites of post-surgical excision, or images with doppler, elastography, or other overlays present in them.
» Koios DS software is not intended for use on portable handheld devices (e.g. smartphones or tablets) or as a primary diagnostic viewer of mammography images.
* The software does not predict the presence of the thyroid nodule margin descriptor, extra-thyroidal extension. In the event that this condition is present, the user may select this category manually from the margin descriptor list.
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/K212616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212616: Koios DS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212616
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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