K231470
- 510(k) number
- K231470
- Device name
- Lunit INSIGHT DBT
- Applicant
- Lunit, Inc. KR
- Product code
- QDQ — Radiological Computer Assisted Detection/Diagnosis S
- Decision date
- 2023-11-06
- Date received
- 2023-05-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K231470.pdf
Official FDA record: K231470
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.