Radiology · 510(k) · 2026
Lunit INSIGHT DBT (V1.2)
Lunit, Inc.. Cleared by FDA on 26 March 2026 under submission K253796, product code QDQ (radiological computer assisted detection/diagnosis software for lesions suspicious for cancer). What FDA's record says, in FDA's words.
Device record · K253796
- Device. Lunit INSIGHT DBT (V1.2)DEVICE
- Company. Lunit, Inc. (KR)COMPANY
- Decision. 26 March 2026, 510(k), substantially equivalent (traditional review); received 28 November 2025DECISION
- Panel. RadiologyPANEL
- Product code. QDQ, Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For CancerCODE
- Regulation. 21 CFR 892.2090, Class IIREG
- Source. FDA database entry · decision document (12 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Lunit INSIGHT DBT is a computer-assisted detection and diagnosis (CADe/x) software intended to be used concurrently by interpreting physicians to aid in the detection and characterization of suspected lesions for breast cancer in digital breast tomosynthesis (DBT) exams from compatible DBT systems. Through the analysis, the regions of soft tissue lesions and calcifications are marked with an abnormality score indicating the likelihood of the presence of malignancy for each lesion. Lunit INSIGHT DBT uses screening mammograms of the female population. Lunit INSIGHT DBT is not intended as a replacement for a complete interpreting physician’s review or their clinical judgment that takes into account other relevant information from the image or patient history.
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QDQ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QDQ, in Radiology, from Lunit, Inc., or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.