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Syngo Carbon Clinicals
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 11824011Model MDR_05_FOR_SYNGO_SaMD_IIbRef 11665628Ref 11665568Ref 11665330
Identity
- Trade Name
- Syngo Carbon Clinicals EUDAMEDFDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- MDR_05_FOR_SYNGO_SaMD_IIb EUDAMED
- Model / Reference
- MDR_05_FOR_SYNGO_SaMD_IIb EUDAMED11824011 EUDAMED11665628 EUDAMED11665568 EUDAMED11665330 EUDAMEDVA3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04068151022162 EUDAMED04056869985947 EUDAMEDFDA UDI04056869979113 EUDAMED04056869961101 EUDAMED
- Basic UDI-DI
- 0405686901978WU EUDAMED
- 510(k) Number
- K232856 FDA UDI
- FDA Product Code
- QIH 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 IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Syngo Carbon Clinicals by Siemens Healthcare GmbH — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, 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 | K232856 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 0405686901978WU | Class IIb | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare GmbH
- EUDAMED SRN
- DE-MF-000006122
Sources (6)
- EUDAMED 2b5230bc-4324-4c02-bff5-92cd3cdf760a 61 fields · synced Oct 6, 2026
- EUDAMED a5c7a652-30bb-4d3a-bab3-6f7f8976af0d 61 fields · synced May 17, 2026
- FDA UDI c72845c1-a758-4eb0-9ee2-4096e3a21d54 34 fields · synced May 27, 2026
- EUDAMED c4791e5c-8fe5-49f9-bf34-9ab041e15946 61 fields · synced Jul 16, 2026
- EUDAMED 2bb9f104-958c-4662-ba04-1532b27a1697 61 fields · synced Jul 19, 2026
- FDA 510(k) K232856 1 fields · synced May 18, 2026