Flat Panel Digital X-ray Detector
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- EXPD-N series FDA UDI
- Generic Name
- Indirect flat panel x-ray detector FDA UDI
- Device Name
- Flat Panel Digital X-ray Detector EUDAMED
- Model / Reference
- EXPD 129P EUDAMEDEXPD 4343N1 EUDAMEDFDA UDIEXPD 3643NU EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800018430002 EUDAMEDFDA UDI08800018430804 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000184DGXXXXXXXXRV EUDAMED
- Direct Marketing DI
- 08800018430002 EUDAMED08800018430804 EUDAMED
- 510(k) Number
- K243443 FDA UDI
- FDA Product Code
- MQB FDA UDI
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
- GMDN Term
- Indirect flat panel x-ray detector FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Stationary basic diagnostic x-ray system, digital
Flat Panel Digital X-ray Detector by DRTECH Corporation — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243443 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 88000184DGXXXXXXXXRV | Class IIa | Active |
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Manufacturer
- Manufacturer
- DRTECH Corporation
- EUDAMED SRN
- KR-MF-000012441
- Authorised Representative
- DRTECH Europe GmbH DE-AR-000011974
Sources (5)
- EUDAMED 979f603a-247c-4cc4-88b7-9c096bbe5648 85 fields · synced Jul 15, 2026
- FDA UDI 4b8cc2e4-4b72-48ca-9b41-75325ec0cb48 33 fields · synced May 25, 2026
- FDA UDI dd84a040-156d-4088-a469-0580e99efe06 33 fields · synced May 30, 2026
- EUDAMED e43f9825-fa9a-4319-9227-923b78ccc90b 61 fields · synced Jul 15, 2026
- FDA 510(k) K243443 1 fields · synced May 18, 2026