Identity
- Trade Name
- SOMATOM Emotion 16-slice configuration FDA UDI
- Generic Name
- Full-body CT system FDA UDI
- Model / Reference
- 10165977 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056869010304 FDA UDI
- 510(k) Number
- K050297 FDA UDI
- FDA Product Code
- JAK FDA UDI
- GMDN Term
- Full-body CT system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
SOMATOM Emotion 16-slice configuration by Siemens Shanghai Medical Equipment Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K050297 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Shanghai Medical Equipment Ltd.
Sources (1)
- FDA UDI b8aae137-65cf-49a4-bb77-3f85b722a086 36 fields · synced May 30, 2026