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Auto Lung Nodule Detection
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref Auto Lung Nodule Detection
Identity
- Trade Name
- Auto Lung Nodule Detection EUDAMED
- Device Name
- Application Software for Digital Diagnostic X-ray System EUDAMED
- Model / Reference
- Auto Lung Nodule Detection EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08801643467098 EUDAMED
- Basic UDI-DI
- 8806090DGRSW0015Y EUDAMED
- EMDN Code
- Z11031192 SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Auto Lung Nodule Detection by Samsung Electronics Co., Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, 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 | K201560 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8806090DGRSW0015Y | Class IIa | Active |
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Manufacturer
- Manufacturer
- Samsung Electronics Co., Ltd
- EUDAMED SRN
- KR-MF-000020682
- Authorised Representative
- Samsung Electronics GmbH DE-AR-000007005
Sources (2)
- EUDAMED bf42e60f-e128-4339-832b-ae7ff2d97e1a 61 fields · synced Jul 10, 2026
- FDA 510(k) K201560 1 fields · synced May 18, 2026