FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
DeepHealth ProstateAI
K Number: K253682
·
Decision Apr 29, 2026
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
34
Applicant Total
11
Review Days
159
Basic Information
- Device Name
- DeepHealth ProstateAI
- K Number
- K253682
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2090
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quantib B.V.
- Date Received
- November 21, 2025
- Decision Date
- April 29, 2026
- Product Code
- QDQ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | FDA class 2 | Radiology |
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Other Clearances by Quantib B.V.
| K Number | Device Name | ||
|---|---|---|---|
| K251527 | Brain WMH | Sep 25, 2025 | Substantially Equivalent |
| K230772 | Quantib Prostate | Apr 17, 2023 | Substantially Equivalent |
| K221106 | Quantib Prostate | May 13, 2022 | Substantially Equivalent |
| K213737 | Quantib ND | Jan 14, 2022 | Substantially Equivalent |
| K202501 | Quantib Prostate | Oct 11, 2020 | Substantially Equivalent |
| K200899 | Quantib AI Node | Jun 15, 2020 | Substantially Equivalent |
| K182564 | Quantib ND | Dec 27, 2018 | Substantially Equivalent |
| K173939 | Quantib Brain | Mar 9, 2018 | Substantially Equivalent |
| K163013 | Quantib Brain 1.2 | Jan 6, 2017 | Substantially Equivalent |
| K153351 | Quantib Brain 1 | Jun 17, 2016 | Substantially Equivalent |