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syngo.via RT Image Suite
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 11546418Model syngo.CT PP_IIb_App_ERLN H 127
Identity
- Trade Name
- syngo.via RT Image Suite EUDAMEDFDA UDI
- Generic Name
- CT system application software FDA UDI
- Device Name
- syngo.CT PP_IIb_App_ERLN H 127 EUDAMED
- Model / Reference
- 11546418 EUDAMEDFDA UDIsyngo.CT PP_IIb_App_ERLN H 127 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056869287393 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686901998X2 EUDAMED
- 510(k) Number
- K220783 FDA UDI
- FDA Product Code
- MUJ FDA UDI
- EMDN Code
- Z11030692 COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- CT system application software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: CT system application software
syngo.via RT Image Suite by Siemens Healthcare — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare
Sources (2)
- FDA UDI 02ae9085-bcba-441b-b1e3-cb7ba0470a86 34 fields · synced Jul 21, 2026
- EUDAMED 8b70f622-14fa-4323-b7c6-4d20bf137533 61 fields · synced Jul 21, 2026