Identity
- Trade Name
- aiOS EUDAMEDFDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- aiOS EUDAMEDThe AI Operating System (aiOS) is a Medical Image Communication Device, indicated to route radiological studies for processing by Integrated AI Solutions (IAIS), and to display their results. FDA UDI
- Model / Reference
- aiOS EUDAMED3.x.y FDA UDI
- Description
- The AI Operating System (aiOS) is a Medical Image Communication Device, indicated to route radiological studies for processing by Integrated AI Solutions (IAIS), and to display their results. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290018052198 EUDAMEDFDA UDI
- Basic UDI-DI
- 729001805219AD EUDAMED
- Direct Marketing DI
- 07290018052198 EUDAMED
- FDA Product Code
- LMD FDA UDI
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.2020 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
aiOS by Aidoc Medical Ltd — Class I — 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 | 729001805219AD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aidoc Medical Ltd.
- EUDAMED SRN
- IL-MF-000030988
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 56e6d1d7-f839-4674-8c91-2aaaa944eb2e 61 fields · synced Jun 18, 2026
- FDA UDI 349be348-5218-4d2a-8790-96910cda638c 33 fields · synced May 30, 2026