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syngo.CT Dual Energy
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 11546407Model syngo.CT PP_IIa_App_ERLN H 127
Identity
- Trade Name
- syngo.CT Dual Energy EUDAMEDFDA UDI
- Generic Name
- Full-body CT system FDA UDI
- Device Name
- syngo.CT PP_IIa_App_ERLN H 127 EUDAMED
- Model / Reference
- syngo.CT PP_IIa_App_ERLN H 127 EUDAMED11546407 EUDAMED11060597 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056869290416 EUDAMED04056869013923 FDA UDI
- Basic UDI-DI
- 0405686900118UT EUDAMED
- FDA Product Code
- JAK FDA UDI
- EMDN Code
- Z11030682 COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Full-body CT system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 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: Full-body CT system
syngo.CT Dual Energy by Siemens Healthcare — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K150745 also covers:
K150757 also covers:
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 7f5018b6-32cf-4088-9a9b-4cd5529eb495 35 fields · synced Jul 22, 2026
- EUDAMED e502374a-4d51-464b-a94e-435630563599 61 fields · synced Jul 22, 2026