FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
MammoScreen 2.0
K Number: K211541
·
Decision Nov 26, 2021
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
34
Applicant Total
6
Review Days
191
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Basic Information
- Device Name
- MammoScreen 2.0
- K Number
- K211541
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2090
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Therapixel
- Date Received
- May 19, 2021
- Decision Date
- November 26, 2021
- 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 Therapixel
| K Number | Device Name | ||
|---|---|---|---|
| K243685 | MammoScreen BD | Aug 22, 2025 | Substantially Equivalent |
| K243679 | MammoScreen® (4) | Jul 3, 2025 | Substantially Equivalent |
| K241561 | MammoScreen BD | Oct 2, 2024 | Substantially Equivalent |
| K240301 | MammoScreen® (3) | Aug 1, 2024 | Substantially Equivalent |
| K192854 | MammoScreen | Mar 25, 2020 | Substantially Equivalent |