K253796 is an FDA 510(k) clearance for the Lunit INSIGHT DBT (V1.2). This device is classified as a Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer (Class II - Special Controls, product code QDQ).
Submitted by Lunit, Inc. (Seoul, KR). The FDA issued a Cleared decision on March 26, 2026, 118 days after receiving the submission on November 28, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2090. 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) Number | K253796 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 2025 |
| Decision Date | March 26, 2026 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | QDQ - Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2090 |
| 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. |