MammoScreen 2.0
FDA 510(k) K211541 · Therapixel
Submission
- Device name
- MammoScreen 2.0
- Applicant
- Therapixel
Nice, FR - Received
- May 19, 2021
- Decision date
- November 26, 2021
- 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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|---|---|---|---|
| K260898 | Transpara (2.1.0)QDQ · Special | Screenpoint Medical B.V. | 08/14/2026SE |
| K260086 | CadAI-B DxQDQ · Traditional | BeamWorks, Inc. | 08/12/2026SE |
| K260303 | See-Mode Augmented Reporting Tool, Breast (SMART-B)QDQ · Traditional | See-Mode Technologies Pty, Ltd. | 07/28/2026SE |
| K260714 | MammoScreen® (5)QDQ · Special | Therapixel | 06/26/2026SE |
| K253825 | Saige-DxQDQ · Traditional | DeepHealth, Inc. | 06/15/2026SE |
| K253682 | DeepHealth ProstateAIQDQ · Traditional | Quantib B.V. | 04/29/2026SE |
| K260320 | Lunit INSIGHT MMG (v1.1.10)QDQ · Special | Lunit, Inc. | 04/23/2026SE |
| K253796 | Lunit INSIGHT DBT (V1.2)QDQ · Traditional | Lunit, Inc. | 03/26/2026SE |
| K251474 | Median LCS (internal name) / eyonis LCS (trade name) (1.0)QDQ · Traditional | Median Technologies | 02/06/2026SE |
| K251873 | Saige-DxQDQ · Special | DeepHealth, Inc. | 08/11/2025SE |
More from DeepHealth, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260714 | MammoScreen® (5)QDQ · Special | 06/26/2026SE |
| K243685 | MammoScreen BDQIH · Traditional | 08/22/2025SE |
| K243679 | MammoScreen® (4)QDQ · Traditional | 07/03/2025SE |
| K241561 | MammoScreen BDQIH · Traditional | 10/02/2024SE |
| K240301 | MammoScreen® (3)QDQ · Traditional | 08/01/2024SE |
| K192854 | MammoScreenQDQ · Traditional | 03/25/2020SE |
Questions and answers
When was MammoScreen 2.0 cleared by the FDA?
MammoScreen 2.0 (K211541) received a 510(k) decision of Substantially Equivalent on November 26, 2021, 191 days after the submission was received.
What is the product code of K211541?
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.