QDQ — Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer Class II
Classification Details
- Product Code
- QDQ
- Device Class
- Class II
- Regulation Number
- 892.2090
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251474 | median technologies | Median LCS (internal name) / eyonis LCS (trade name) (1.0) | February 6, 2026 |
| K251873 | deephealth | Saige-Dx | August 11, 2025 |
| K243341 | hologic | Genius AI Detection 2.0 | July 31, 2025 |
| K243679 | therapixel | MammoScreen® (4) | July 3, 2025 |
| K242683 | quibim s.l | QP-Prostate® CAD | March 18, 2025 |
| K241770 | siemens healthcare | Prostate MR AI (VA10A) | March 5, 2025 |
| K243688 | deephealth | Saige-Dx (3.1.0) | December 19, 2024 |
| K241831 | screenpoint medical | Transpara (2.1.0) | November 25, 2024 |
| K241747 | deephealth | Saige-Dx | November 18, 2024 |
| K240417 | icad | ProFound Detection (V4.0) | November 8, 2024 |
| K242652 | lunit | Lunit INSIGHT DBT v1.1 | October 4, 2024 |
| K240697 | see-mode technologies pte | See-Mode Augmented Reporting Tool, Thyroid (SMART-T) | September 9, 2024 |
| K240301 | therapixel | MammoScreen® (3) | August 1, 2024 |
| K231470 | lunit | Lunit INSIGHT DBT | November 6, 2023 |
| K230096 | hologic | Genius AI Detection 2.0 with CC-MLO Correlation | May 23, 2023 |
| K221449 | hologic | Genius AI Detection 2.0 | October 6, 2022 |
| K221347 | screenpoint medical | Transpara 1.7.2 | August 3, 2022 |
| K212783 | scanmed | ProstatID | July 8, 2022 |
| K220105 | deephealth | Saige-Dx | May 12, 2022 |
| K210670 | taihao medical | BU-CAD | December 21, 2021 |