Identity
- Trade Name
- ClearRead CT EUDAMEDClearRead CT Console FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- ClearRead CT EUDAMEDClearRead CT Console FDA UDI
- Model / Reference
- 5.7.0 EUDAMEDFDA UDI
- Description
- ClearRead CT Console FDA UDI
Identifiers
- Primary DI / UDI-DI
- M722CC23171V231710 EUDAMEDFDA UDI
- Basic UDI-DI
- ++M722CVEB EUDAMED
- Direct Marketing DI
- M722CC23171V231710 EUDAMED
- FDA Product Code
- OEB FDA UDILLZ FDA UDI
- EMDN Code
- Z119092 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Austria 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
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
The ClearRead CT device is a high-quality, Class IIa medical imaging system designed for accurate and efficient diagnostic imaging. By utilizing advanced image reconstruction algorithms and noise reduction techniques, this device provides excellent image quality and reduces the risk of artifacts.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++M722CVEB | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Riverain Technologies, Inc.
- EUDAMED SRN
- US-MF-000003233
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED d3d5f4cf-d11f-4e81-9a6b-eab389b21b02 61 fields · synced Jul 24, 2026
- FDA UDI 9bc33ff1-a10c-48e2-a932-d1da5733524e 33 fields · synced May 30, 2026