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ClearRead Xray Pneumothorax
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1.1.1Model ClearRead Xray Pneumothorax
Identity
- Trade Name
- ClearRead Xray Pneumothorax EUDAMEDClearRead Xray | Pneumothorax FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- ClearRead Xray Pneumothorax EUDAMEDClearRead Xray Pneumothorax on Console Platform FDA UDI
- Model / Reference
- ClearRead Xray Pneumothorax EUDAMED1.1.1 EUDAMEDFDA UDI
- Description
- ClearRead Xray Pneumothorax on Console Platform FDA UDI
Identifiers
- Primary DI / UDI-DI
- M722XC22145P212210 EUDAMEDFDA UDI
- Basic UDI-DI
- ++M722XPFW EUDAMED
- Direct Marketing DI
- M722XC22145P212210 EUDAMED
- FDA Product Code
- QFM 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
- 892.2080 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Austria 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 Pneumothorax by Riverain Technologies, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | ++M722XPFW | 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 6088164b-04df-44fd-a77e-20983ea2fdc5 61 fields · synced Jul 27, 2026
- FDA UDI 79816e80-fa67-4fb2-be94-41da5cd08fde 33 fields · synced May 30, 2026