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SOMATOM go.Top
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 11061648Model SOMATOM CT-Scanner_SHA NH
Identity
- Trade Name
- SOMATOM go.Top EUDAMEDFDA UDI
- Generic Name
- Full-body CT system FDA UDI
- Device Name
- SOMATOM CT-Scanner_SHA NH EUDAMED
- Model / Reference
- 11061648 EUDAMEDFDA UDISOMATOM CT-Scanner_SHA NH EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056869151595 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686900124UN EUDAMED
- 510(k) Number
- K173632 FDA UDI
- FDA Product Code
- JAK FDA UDI
- EMDN Code
- Z11030605 COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS EUDAMED
- GMDN Term
- Full-body CT system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- 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
SOMATOM go.Top by Siemens Shanghai Medical Equipment Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Full-body CT system.
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Cleared under the same submission
K173632 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 Shanghai Medical Equipment Ltd.
Sources (2)
- FDA UDI de97b195-2e5b-4c34-8374-5b510378082b 35 fields · synced Jul 15, 2026
- EUDAMED 5b252149-21d7-4282-a014-e8cc10b76cdd 61 fields · synced Jul 15, 2026