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Lunit INSIGHT DBT (V1.2)
FDA 510(k)Class II (US FDA 510(k))
510(k) K253796
by Lunit Inc.
Identifiers
- 510(k) Number
- K253796 FDA 510(k)
- FDA Product Code
- QDQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2090 FDA 510(k)
- Regulation Number
- 892.2090 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Lunit INSIGHT DBT (V1.2) by Lunit Inc. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253796 | Class II | Active |
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Manufacturer
- Manufacturer
- Lunit Inc.
- FDA Applicant
- Lunit, Inc.
Sources (1)
- FDA 510(k) K253796 24 fields · synced Jun 19, 2026