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.. Device class: 2.
Clearance details
- Applicant
- Lunit, Inc.
- Product code
- Code QDQ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2090
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
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