DIGITAL RADIOGRAPHY CXDI-Pro
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
by Canon Inc.
Identity
- Trade Name
- DIGITAL RADIOGRAPHY CXDI-Pro EUDAMEDCANON INC. FDA UDI
- Generic Name
- Computed radiography digital imaging scanner FDA UDI
- Device Name
- CXDI-Pro EUDAMED
- Model / Reference
- Digital Radiography EUDAMEDBT8-1855 EUDAMEDCXDI-Pro FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04549292200935 EUDAMEDFDA UDI
- Basic UDI-DI
- 4549292dr01CU EUDAMED
- FDA Product Code
- MQB FDA UDI
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
- GMDN Term
- Computed radiography digital imaging scanner FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Market of Registration
- Netherlands 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
No
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
No
Category: Stationary basic diagnostic x-ray system, digital
DIGITAL RADIOGRAPHY CXDI-Pro by Canon Inc. — 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
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222855 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K220098 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K221876 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4549292dr01CU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Canon Inc.
- EUDAMED SRN
- JP-MF-000013254
- Authorised Representative
- Canon Medical Components Europe B.V. NL-AR-000029305
Sources (3)
- EUDAMED af20638b-79be-436b-a017-9e59d66017a6 61 fields · synced Jul 9, 2026
- FDA UDI a7cd835d-87e3-4d02-b049-ad0931ae7cdc 32 fields · synced May 30, 2026
- FDA 510(k) K222855 1 fields · synced Jun 9, 2026