Expd 4343p
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- EXPD 4343P EUDAMEDExprimer FDA UDI
- Generic Name
- Indirect flat panel x-ray detector FDA UDI
- Device Name
- Flat Panel Digital X-ray Detector EUDAMEDThe EXPD 4343P Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications. FDA UDI
- Model / Reference
- EXPD 129P EUDAMEDEXPD 4343P EUDAMEDFDA UDI
- Description
- The EXPD 4343P Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800018406304 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000184DGXXXXXXXXRV EUDAMED
- 510(k) Number
- K193031 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
Expd 4343p 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 | K232082 | 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 (3)
- EUDAMED 49011959-8f5b-4cfb-89ae-65d432b96aed 61 fields · synced Jul 25, 2026
- FDA UDI 01aeb9ce-b14f-4978-88b5-bb6f2cbecc84 34 fields · synced May 30, 2026
- FDA 510(k) K232082 1 fields · synced May 18, 2026