Lunit INSIGHT CXR Triage— 510(k) K211733
Substantially EquivalentLunit, Inc.
FDA 510(k) clearance K211733 for Lunit INSIGHT CXR Triage, Substantially Equivalent on 2021-11-10. Applicant: Lunit, Inc.. Device class: 2.
Clearance details
- Applicant
- Lunit, Inc.
- Product code
- Code QFM
- Device class
- Class 2
- Regulation
- 21 CFR 892.2080
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
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