Lunit INSIGHT DBT— 510(k) K231470
Substantially EquivalentLunit, Inc.
FDA 510(k) clearance K231470 for Lunit INSIGHT DBT, Substantially Equivalent on 2023-11-06. Applicant: Lunit, Inc..
Clearance details
- Applicant
- Lunit, Inc.
- Product code
- Code QDQ
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
Data sourced from openFDA. This site is unofficial and independent of the FDA.