Identity
- Trade Name
- Lunit INSIGHT DBT EUDAMEDFDA UDI
- Generic Name
- X-ray image interpretive software FDA UDI
- Device Name
- Lunit INSIGHT MMG EUDAMED
- Model / Reference
- 126012 EUDAMED1.1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800076000162 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000760MMGXH EUDAMED
- 510(k) Number
- K242652 FDA UDI
- FDA Product Code
- QDQ FDA UDI
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- X-ray image interpretive software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2090 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Lunit INSIGHT DBT by Lunit Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000760MMGXH | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Lunit Inc.
- EUDAMED SRN
- KR-MF-000005200
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED e92e030f-c08a-455e-96e3-42078a3f6074 61 fields · synced Jul 21, 2026
- FDA UDI e5e12fce-56e0-409e-9544-3ba52133781c 33 fields · synced May 29, 2026