FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Lunit INSIGHT DBT (V1.2)
K Number: K253796
·
Decision Mar 26, 2026
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
34
Applicant Total
6
Review Days
118
Basic Information
- Device Name
- Lunit INSIGHT DBT (V1.2)
- K Number
- K253796
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2090
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lunit, Inc.
- Date Received
- November 28, 2025
- Decision Date
- March 26, 2026
- Product Code
- QDQ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | FDA class 2 | Radiology |
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Other Clearances by Lunit, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260320 | Lunit INSIGHT MMG (v1.1.10) | Apr 23, 2026 | Substantially Equivalent |
| K242652 | Lunit INSIGHT DBT v1.1 | Oct 4, 2024 | Substantially Equivalent |
| K231470 | Lunit INSIGHT DBT | Nov 6, 2023 | Substantially Equivalent |
| K211678 | Lunit INSIGHT MMG | Nov 17, 2021 | Substantially Equivalent |
| K211733 | Lunit INSIGHT CXR Triage | Nov 10, 2021 | Substantially Equivalent |