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Lunit INSIGHT DBT
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 126012
by Lunit Inc.
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 EUDAMED1.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800076000148 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000760MMGXH EUDAMED
- 510(k) Number
- K231470 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
- Germany 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 — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231470 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 88000760MMGXH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Lunit Inc.
- EUDAMED SRN
- KR-MF-000005200
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 1a690f2c-c989-4963-906c-99236cf81387 61 fields · synced Jul 30, 2026
- FDA UDI d5c55f38-2f27-4da3-bb66-00a7096d09ce 33 fields · synced May 30, 2026
- FDA 510(k) K231470 1 fields · synced May 18, 2026