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ClearRead CT CAC
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 1.2.2Model ClearRead CT CAC510(k) K242188
Identity
- Trade Name
- ClearRead CT CAC EUDAMED
- Device Name
- ClearRead CT CAC EUDAMED
- Model / Reference
- ClearRead CT CAC EUDAMED1.2.2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- M722CD25281CA252790 EUDAMED
- Basic UDI-DI
- ++M722CCAUJ EUDAMED
- Direct Marketing DI
- M722CD25281CA252790 EUDAMED
- EMDN Code
- Z119092 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ClearRead CT CAC by Riverain Technologies, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, 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 | K242188 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++M722CCAUJ | Class IIa | Active |
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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 a2e11f71-6c40-41af-b7f4-63e4068ad8d5 85 fields · synced Jun 19, 2026
- FDA 510(k) K242188 1 fields · synced May 18, 2026