De Novo · Granted
GrantedQuantX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantitative Insights, Inc. · POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Granted on Jul 19, 2017 as a new device type through De Novo after a 103-day review. 22 later devices descend from it.
- Decided
- Jul 19, 2017
- Review
- 103 days
- Class
- Class II
- Product code
- POK
- Recalls
- None
22 later devices descend from it, 4 citing it directly.
- This deviceDEN170022 QuantXQuantitative Insights, Inc. · 2017
- 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 · cites it directly · 5 of its ownK200760 Rapid ASPECTSIschemaview, Inc. · 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
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K190442Koios DS for BreastKoios Medical, Inc. · 2019 · cites it directly12descendants
- K201555EchoGo ProUltromics, Ltd. · 2020 · 2 generations on6descendants
- K200760Rapid ASPECTSIschemaview, Inc. · 2020 · cites it directly5descendants
- K212616Koios DSKoios Medical, Inc. · 2021 · 2 generations on4descendants
- K242342Fetal EchoScanBrightheart · 2024 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN170022 | QuantX | Quantitative Insights, Inc. | 2017 | — |
| +1 | K190442 | Koios DS for Breast | Koios Medical, Inc. | 2019 | — |
| +2 | K201555 | EchoGo Pro | Ultromics, Ltd. | 2020 | — |
| +1 | K200760 | Rapid ASPECTS | Ischemaview, Inc. | 2020 | — |
| +2 | K212616 | Koios DS | Koios Medical, Inc. | 2021 | — |
| +3 | K242342 | Fetal EchoScan | Brightheart | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (22)
See all 224 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?
- Of its descendants, K190442 (Koios Medical, Inc., 2019) has gone furthest, with 12 descendants of its own.
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. 2017, 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?
QuantX is a computer-aided diagnosis (CADx) software device used to assist radiologists in the assessment and characterization of breast abnormalities using MR image data. The software automatically registers images, and segments and analyzes user-selected regions of interest (ROI). QuantX extracts image data from the ROI to provide volumetric analysis and computer analytics based on morphological and enhancement characteristics. These imaging (or…
Read the full statement (251 words)
QuantX is a computer-aided diagnosis (CADx) software device used to assist radiologists in the assessment and characterization of breast abnormalities using MR image data. The software automatically registers images, and segments and analyzes user-selected regions of interest (ROI). QuantX extracts image data from the ROI to provide volumetric analysis and computer analytics based on morphological and enhancement characteristics. These imaging (or radiomic) features are then synthesized by an artificial intelligence algorithm into a single value, the QI score, which is analyzed relative to a database of reference abnormalities with known ground truth.
QuantX is indicated for evaluation of patients presenting for high-risk screening, diagnostic imaging workup, or evaluation of extent of known disease. Extent of known disease refers to both the assessment of the boundary of a particular abnormality as well as the assessment of the total disease burden in a particular patient. In cases where multiple abnormalities are present, QuantX can be used to assess each abnormality independently.
This device provides information that may be useful in the characterization of breast abnormalities during image interpretation. For the QI score and component radiomic features, the QuantX device provides comparative analysis to lesions with known outcomes using an image atlas and histogram display format.
QuantX may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software also includes tools that allow users to measure and document images, and output in a structured report.
Limitations: QuantX is not intended for primary interpretation of digital mammography images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN170022 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN170022: QuantX.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN170022
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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