DeepHealth ProstateAI
FDA 510(k) K253682 · Quantib B.V.
Submission
- Device name
- DeepHealth ProstateAI
- Applicant
- Quantib B.V.
Rotterdam, NL - Received
- November 21, 2025
- Decision date
- April 29, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QDQ – Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2090
- Specialty
- Radiology
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…
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Questions and answers
When was DeepHealth ProstateAI cleared by the FDA?
DeepHealth ProstateAI (K253682) received a 510(k) decision of Substantially Equivalent on April 29, 2026, 159 days after the submission was received.
What is the product code of K253682?
The FDA product code is QDQ – Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer, a Class II (moderate risk) device regulated under 21 CFR 892.2090.