Radiology · 510(k) · 2026
DeepHealth ProstateAI
Quantib B.V.. Cleared by FDA on 29 April 2026 under submission K253682, product code QDQ (radiological computer assisted detection/diagnosis software for lesions suspicious for cancer). What FDA's record says, in FDA's words.
Device record · K253682
- Device. DeepHealth ProstateAIDEVICE
- Company. Quantib B.V. (NL)COMPANY
- Decision. 29 April 2026, 510(k), substantially equivalent (traditional review); received 21 November 2025DECISION
- Panel. RadiologyPANEL
- Product code. QDQ, Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For CancerCODE
- Regulation. 21 CFR 892.2090, Class IIREG
- Source. FDA database entry · decision document (11 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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.
The product code's definition, from FDA's classification record. A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images (e.g., mammography , MR, CT, ultrasound, radiography). The device detects, identifies and characterizes lesions suspicious for cancer based on features or information extracted from the images, and may provide information about the presence, location, and characteristics of the lesion to the user. Primary diagnostic and patient management decisions are made by the clinical user.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedMRI
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QDQ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QDQ, in Radiology, from Quantib B.V., or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.