# K253682: DeepHealth ProstateAI

- Pathway: 510(k) (Traditional)
- Applicant: Quantib B.V.
- Decided: Apr 29, 2026 after 159 days
- Product code: QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer)
- Device class: 2
- Regulation: 21 CFR 892.2090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN180005 (2018). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212783: ProstatID, Scanmed, LLC (2022) Summary page 6.

## Indications for use
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.

Source page: https://510kreport.com/device/K253682
Methodology: https://510kreport.com/methodology