Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
The Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images such as mammography, MRI, CT, ultrasound, and radiography; primary diagnostic and patient management decisions are made by the clinical user. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 892.2090 in the Radiology specialty. The product code is QDQ. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QDQ
- Device Class
- FDA class 2
- Regulation Number
- 892.2090
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
Definition
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 features or information extracted from the images, and may provide information about the presence, location, and characteristics of the lesion to the user. Primary diagnostic and patient management decisions are made by the clinical user.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 35 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K253825 | Saige-Dx | Jun 15, 2026 | Substantially Equivalent | DeepHealth, Inc. |
| K253682 | DeepHealth ProstateAI | Apr 29, 2026 | Substantially Equivalent | Quantib B.V. |
| K260320 | Lunit INSIGHT MMG (v1.1.10) | Apr 23, 2026 | Substantially Equivalent | Lunit, Inc. |
| K253796 | Lunit INSIGHT DBT (V1.2) | Mar 26, 2026 | Substantially Equivalent | Lunit, Inc. |
| K251474 | Median LCS (internal name) / eyonis LCS (trade name) (1.0) | Feb 06, 2026 | Substantially Equivalent | Median Technologies |
| K251873 | Saige-Dx | Aug 11, 2025 | Substantially Equivalent | DeepHealth, Inc. |
| K243341 | Genius AI Detection 2.0 | Jul 31, 2025 | Substantially Equivalent | Hologic, Inc. |
| K243679 | MammoScreen® (4) | Jul 03, 2025 | Substantially Equivalent | Therapixel |
| K242683 | QP-Prostate® CAD | Mar 18, 2025 | Substantially Equivalent | Quibim S.L. |
| K241770 | Prostate MR AI (VA10A) | Mar 05, 2025 | Substantially Equivalent | Siemens Healthcare GmbH |
| K243688 | Saige-Dx (3.1.0) | Dec 19, 2024 | Substantially Equivalent | DeepHealth, Inc. |
| K241831 | Transpara (2.1.0) | Nov 25, 2024 | Substantially Equivalent | Screenpoint Medical B.V. |
| K241747 | Saige-Dx | Nov 18, 2024 | Substantially Equivalent | DeepHealth, Inc. |
| K240417 | ProFound Detection (V4.0) | Nov 08, 2024 | Substantially Equivalent | Icad, Inc. |
| K242652 | Lunit INSIGHT DBT v1.1 | Oct 04, 2024 | Substantially Equivalent | Lunit, Inc. |
| K240697 | See-Mode Augmented Reporting Tool, Thyroid (SMART-T) | Sep 09, 2024 | Substantially Equivalent | See-Mode Technologies Pte, Ltd. |
| K240301 | MammoScreen® (3) | Aug 01, 2024 | Substantially Equivalent | Therapixel |
| K231470 | Lunit INSIGHT DBT | Nov 06, 2023 | Substantially Equivalent | Lunit, Inc. |
| K230096 | Genius AI Detection 2.0 with CC-MLO Correlation | May 23, 2023 | Substantially Equivalent | Hologic, Inc. |
| K221449 | Genius AI Detection 2.0 | Oct 06, 2022 | Substantially Equivalent | Hologic, Inc. |
| K221347 | Transpara 1.7.2 | Aug 03, 2022 | Substantially Equivalent | Screenpoint Medical B.V. |
| K212783 | ProstatID | Jul 08, 2022 | Substantially Equivalent | Scanmed, LLC |
| K220105 | Saige-Dx | May 12, 2022 | Substantially Equivalent | DeepHealth, Inc. |
| K210670 | BU-CAD | Dec 21, 2021 | Substantially Equivalent | Taihao Medical, Inc. |
| K211541 | MammoScreen 2.0 | Nov 26, 2021 | Substantially Equivalent | Therapixel |
| K211678 | Lunit INSIGHT MMG | Nov 17, 2021 | Substantially Equivalent | Lunit, Inc. |
| K210404 | Transpara 1.7.0 | Jun 02, 2021 | Substantially Equivalent | Screenpoint Medical B.V. |
| K203822 | ProFound AI Software V3.0 | Mar 12, 2021 | Substantially Equivalent | Icad, Inc. |
| K201019 | Genius AI Detection | Nov 18, 2020 | Substantially Equivalent | Hologic, Inc. |
| K192854 | MammoScreen | Mar 25, 2020 | Substantially Equivalent | Therapixel |
| K193229 | Transpara | Mar 05, 2020 | Substantially Equivalent | Screenpoint Medical B.V. |
| K192287 | Transpara | Dec 10, 2019 | Substantially Equivalent | Screenpoint Medical B.V. |
| K191994 | ProFound AI Software V2.1 | Oct 04, 2019 | Substantially Equivalent | Icad, Inc. |
| K182373 | PowerLook Tomo Detection V2 Software | Dec 06, 2018 | Substantially Equivalent | Icad, Inc. |
| K181704 | Transpara | Nov 21, 2018 | Substantially Equivalent | Screenpoint Medical B.V. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.