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DIGITAL RADIOGRAPHY CXDI-Elite
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref BT8-1880Model Digital Radiography510(k) K221620
by Canon Inc.
Identity
- Trade Name
- DIGITAL RADIOGRAPHY CXDI-Elite EUDAMEDCANON INC. FDA UDI
- Generic Name
- Computed radiography digital imaging scanner FDA UDI
- Device Name
- CXDI-Pro EUDAMED
- Model / Reference
- Digital Radiography EUDAMEDBT8-1880 EUDAMEDCXDI-Elite FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04549292200942 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
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
No
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
DIGITAL RADIOGRAPHY CXDI-Elite by Canon 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
United States Active
FDA_510K
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 | K213780 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K221620 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K222687 | 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
- FDA Applicant
- Canon, Inc.
- Authorised Representative
- Canon Medical Components Europe B.V. NL-AR-000029305
Sources (3)
- EUDAMED bb12ff10-4254-44e6-9cd6-1d71f69ead34 85 fields · synced Jun 19, 2026
- FDA UDI a7166413-007c-4f91-8ca1-025bc580d00e 33 fields · synced May 29, 2026
- FDA 510(k) K213780 1 fields · synced Jun 9, 2026