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ClearRead Xray Confirm
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 3.0.0510(k) K123526
Identity
- Trade Name
- ClearRead Xray Confirm EUDAMEDClearRead Xray | Confirm FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- ClearRead Xray Confirm EUDAMEDClearRead Confirm on Console Platform FDA UDI
- Model / Reference
- 3.0.0 EUDAMEDFDA UDI
- Description
- ClearRead Confirm on Console Platform FDA UDI
Identifiers
- Primary DI / UDI-DI
- M722XC22145L212210 EUDAMEDFDA UDI
- Basic UDI-DI
- ++M722XLFN EUDAMED
- Direct Marketing DI
- M722XC22145L212210 EUDAMED
- FDA Product Code
- LLZ 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
- Belgium 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
ClearRead Xray Confirm by Riverain Technologies, 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
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123526 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++M722XLFN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Riverain Technologies, Inc.
- EUDAMED SRN
- US-MF-000003233
- FDA Applicant
- Riverain Technologies
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED e90bff57-0755-4e6f-ba8f-496a928c10c6 85 fields · synced Jun 18, 2026
- FDA UDI 4582c820-5c38-4892-8d73-4d1c37854804 33 fields · synced May 30, 2026
- FDA 510(k) K123526 1 fields · synced May 18, 2026