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Ophthalmic Software Platform RX (RX Capture for Retinal Camera +2 more)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BT8-1836Model Ophthalmic Software Platform
by Canon Inc.
Identity
- Trade Name
- Ophthalmic Software Platform RX(RX Capture for Retinal Camera, RX Server, RX Viewer) EUDAMEDCANON INC. FDA UDI
- Generic Name
- Posterior eye segment analyser software FDA UDI
- Device Name
- Ophthalmic Software Platform RX EUDAMED
- Model / Reference
- Ophthalmic Software Platform EUDAMEDBT8-1836 EUDAMEDOphthalmic Software Platform RX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04549292084696 EUDAMEDFDA UDI
- Basic UDI-DI
- 4549292es01D8 EUDAMED
- 510(k) Number
- K173689 FDA UDI
- FDA Product Code
- NFJ FDA UDI
- EMDN Code
- Z12120192 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Posterior eye segment analyser software FDA UDI
- Models / Variants
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ophthalmic Software Platform RX (RX Capture for Retinal Camera +2 more) by Canon Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — 3 models
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4549292es01D8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Canon Inc.
- EUDAMED SRN
- JP-MF-000013254
- Authorised Representative
- Canon Medical Systems Europe B.V. NL-AR-000010531
Sources (2)
- EUDAMED 98c9f51e-5feb-499f-afc4-d73b1099dba2 61 fields · synced Jul 16, 2026
- FDA UDI ae898468-c69e-44dd-93a6-3a9990589c8f 34 fields · synced May 30, 2026