syngo.MI Neurology
by Siemens Medical Solutions USA, Inc. EUDAMED
Active
Ref 11431549Model Image Processing Software_10_IIa_HES
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0405686900137UX | Date29 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Device Name
- Image Processing Software_10_IIa_HES
- Model / Reference
- Image Processing Software_10_IIa_HES, 11431549
- Primary DI / UDI-DI
- 04056869279770
- Basic UDI-DI
- 0405686900137UX
- EMDN Code
- Z110603 Picture archiving and communication systems
- Device Class
- Class IIa
- Special Device Type
- Software
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000016485
- Authorised representative
- Siemens Healthineers AG DE-AR-000038458
Other devices from Siemens Medical Solutions USA, Inc.
Properties
Other properties (13)
- 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