CINA-ASPECTS
EUDAMEDFDA 510(k)Class IIb (EU MDR)
by Avicenna.AI
Identity
- Trade Name
- CINA-ASPECTS EUDAMED
- Device Name
- CINA-ASPECTS EUDAMED
- Model / Reference
- CINA-ASPECTS EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B826CINAASPECTS140 EUDAMED
- Basic UDI-DI
- ++B826CINAASPECTS14NS EUDAMED
- EMDN Code
- Z11039092 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
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
No
Incorporates Medicinal Product
No
CINA-ASPECTS is a Class IIb diagnostic device classified under nomenclature code Z11039092, designed for active medical imaging analysis. It functions as an artificial intelligence-powered system for interpreting and assessing medical imaging data, aiding in diagnostic decision-making processes.
The device is supplied as a non-sterile, non-reusable, non-implantable product and is intended for use in clinical settings where imaging data requires advanced analysis. It is regulated under FDA 510(k) and MDR authorisations, with a unique device identifier (UDI) for traceability. Storage and handling follow standard electronic device protocols, and its active status ensures compliance with current medical imaging standards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233342 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K200855 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K221716 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | ++B826CINAASPECTS14NS | Class IIb | Active |
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Manufacturer
- Manufacturer
- Avicenna.AI
- EUDAMED SRN
- FR-MF-000000324
Sources (2)
- EUDAMED a239aec3-1ca8-4238-b84c-9d68228055b0 61 fields · synced Sep 18, 2026
- FDA 510(k) K233342 1 fields · synced May 18, 2026