510(k) · Cleared
ClearedDeepHealth ProstateAI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantib B.V. · QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Cleared on Apr 29, 2026 as substantially equivalent to K212783 (Scanmed, LLC, 2022) after a 159-day review. Its family tree reaches back 4 generations to 2018.
- Decided
- Apr 29, 2026
- Review
- 159 days
- Class
- Class II
- Product code
- QDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN180005 (2018). No later device cites it as a predicate yet.
- Root · 4 generations backDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- 3 generations backK181704 TransparaScreenpoint Medical B.V. · 2018
- 2 generations backK193229 TransparaScreenpoint Medical B.V. · 2020
- 1 generation backK212783 ProstatIDScanmed, LLC · 2022
- This deviceK253682 DeepHealth ProstateAIQuantib B.V. · 2026
View FIG. 1 as a table
Line of descent and top descendants
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 QDQ? 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 QDQ device
- #1 K241831 Transpara (2.1.0)score 15.6 · 5 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 |
|---|---|---|---|
| * | K212783 | ProstatIDSummary page 6…ssisted detection and diagnosis software (21 CFR 892.2090) Regulation Class: II Product Code: QDQ 3. Predicate Device Trade Name of Device: ProstatID (K212783) Common or Usual Name: ProstatIDTM MRI Diagnostic Aid for Prostate Cancer Classification Names: Radiological Computer Assisted… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 8 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K212783.
How does its category compare?
All QDQ devicesQDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QDQ
10so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QDQ
216in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QDQ
No recall names QDQ since 2007.
Adverse event reports per year · QDQ
No MAUDE report names QDQ since 2007.
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 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 3 | 173 | 0 | 0 |
| 2021 | 5 | 169 | 0 | 0 |
| 2022 | 4 | 131 | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 7 | 153 | 0 | 0 |
| 2025 | 5 | 216 | 0 | 0 |
| 2026 | 10 | 154 | 0 | — |
What is it indicated for?
DeepHealth ProstateAI is a Computer-Aided Detection and Diagnosis (CADe/x) software device developed to aid trained physicians in the detection and characterization of prostate cancer lesions using MR imaging data in patients aged 40 years and older. DeepHealth ProstateAI analyzes T2W, ADC and DWI MR images. Combined with the MR images the software requires a binary mask containing the prostate gland segmentation. Output consists of ROI candidates…
Read the full statement (185 words)
DeepHealth ProstateAI is a Computer-Aided Detection and Diagnosis (CADe/x) software device developed to aid trained physicians in the detection and characterization of prostate cancer lesions using MR imaging data in patients aged 40 years and older. DeepHealth ProstateAI analyzes T2W, ADC and DWI MR images. Combined with the MR images the software requires a binary mask containing the prostate gland segmentation. Output consists of ROI candidates including segmentations, and per ROI a classification indicating the likelihood of prostate cancer. The device is intended to assist in the detection of prostate cancer across the full range of grade groups (ISUP Grade Group ≥ 1), including clinically significant prostate cancer (ISUP Grade Group ≥ 2). Device outputs shall be input for a visualization and adaptation tool. DeepHealth ProstateAI is intended to be used as a concurrent reading aid for physicians assessing prostate MRI exams. Analysis by DeepHealth ProstateAI is not intended as a replacement for interpreting prostate abnormalities using MR image data consistent with clinical recommendations (e.g., including DCE information when available); nor should patient management decisions be made solely based on the results of DeepHealth ProstateAI.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253682 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253682: DeepHealth ProstateAI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253682
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026