510(k) · Cleared
ClearedQP-Prostate® CAD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quibim S.L. · QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Cleared on Mar 18, 2025 as substantially equivalent to K212783 (Scanmed, LLC, 2022) after a 193-day review. Its family tree reaches back 4 generations to 2018.
- Decided
- Mar 18, 2025
- Review
- 193 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 deviceK242683 QP-Prostate® CADQuibim S.L. · 2025
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 5…spicious for cancer Regulatory Class: Class II Product Code: QDQ Predicate Device • Applicant: ScanMed, LLC • Device’s trade name: ProstatIDTM • 510(k) number: K212783 • Product code: QDQ Device Description QP-Prostate® CAD is an artificial intelligence-based Computed Aided Detection and Diag… | 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 7 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. 2025, 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?
QP-Prostate® CAD is a Computed Aided Detection and Diagnosis (CADe/CADx) image processing software that automatically detects and identifies suspected lesions in the prostate gland based on bi-parametric prostate MRI. The software is intended to be used as a concurrent read by physicians with proper training in a clinical setting as an aid for interpreting prostate MRI studies. The results can be displayed in a variety of DICOM outputs, including…
Read the full statement (157 words)
QP-Prostate® CAD is a Computed Aided Detection and Diagnosis (CADe/CADx) image processing software that
automatically detects and identifies suspected lesions in the prostate gland based on bi-parametric prostate MRI. The
software is intended to be used as a concurrent read by physicians with proper training in a clinical setting as an aid for
interpreting prostate MRI studies. The results can be displayed in a variety of DICOM outputs, including identified
suspected lesions marked as an overlay onto source MR images. The output can be displayed on third-party DICOM
workstations and Picture Archive and Communication Systems (PACS). Patient management decisions should not be
based solely on the results of QP-Prostate® CAD.
Intended patient population:
Patients above 40 years with prostate MR imaging.
Intended users:
QP-Prostate® CAD is intended to be used by physicians with proper training, including radiologists, urologists and any
physician qualified to read and interpret prostate MRI consistent with ACR recommendations in the context of PI-RADS.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242683: QP-Prostate® CAD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242683
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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