510(k) K260303
K260303 is an FDA 510(k) premarket notification submitted by See-Mode Technologies Pty, Ltd. for the device "See-Mode Augmented Reporting Tool, Breast (SMART-B)". The FDA issued a decision of Substantially Equivalent on July 28, 2026. The device falls under product code QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer), a Class II device regulated under 21 CFR 892.2090.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2026
- Date Received
- January 30, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
- Device Class
- Class II
- Regulation Number
- 892.2090
- Review Panel
- RA
- Submission Type
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.