Transpara (2.1.0)
FDA 510(k) K260898 · Screenpoint Medical B.V.
Submission
- Device name
- Transpara (2.1.0)
- Applicant
- Screenpoint Medical B.V.
Nijmegen, NL - Received
- March 18, 2026
- Decision date
- August 14, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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More from Hologic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K241831 | Transpara (2.1.0)QDQ · Traditional | 11/25/2024SE |
| K232096 | Transpara Density 1.0.0QIH · Traditional | 12/11/2023SE |
| K221347 | Transpara 1.7.2QDQ · Traditional | 08/03/2022SE |
| K210404 | Transpara 1.7.0QDQ · Traditional | 06/02/2021SE |
| K193229 | TransparaQDQ · Traditional | 03/05/2020SE |
| K192287 | TransparaQDQ · Traditional | 12/10/2019SE |
| K181704 | TransparaQDQ · Traditional | 11/21/2018SE |
Questions and answers
When was Transpara (2.1.0) cleared by the FDA?
Transpara (2.1.0) (K260898) received a 510(k) decision of Substantially Equivalent on August 14, 2026, 149 days after the submission was received.
What is the product code of K260898?
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.