FDA Registration Active 🇨🇳 China

SOMATOM CT Systems with VC50 SW - SOMATOM Perspective, SOMATOM Scope/Scope Power and SOMATOM Emotion 16

Reg #: 3003202425 · FEI: 3003202425 · Expires 2025
Products
2
Proprietary Names
1
Establishment Types
1
Classifications
2

Registration Details

Registration Name
SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.
Registration Number
3003202425
FEI Number
3003202425
Status
Active
Expiry Year
2025
Initial Importer
No
Address
278 ZHOU ZHU RD
City
SHANGHAI
Country
CN

Regulatory Submissions

510(k) Number
K183548

Owner / Operator

Firm Name
Siemens Healthineers AG
Operator Number
8010024
Address
Karlheinz-Kaske-Str. 5, --
City
Erlangen
State
DE-NOTA
Postal Code
91052
Country
DE

US Agent

Business Name
SIEMENS MEDICAL SOLUTIONS USA, INC.
Contact Name
Robert Phillips
Address
40 Liberty Boulevard
City
MALVERN
State
PA
ZIP
19355
Country
US
Phone
302 2359839

Products

Device Name Product Code
System, X-Ray, Tomography, Computed JAK
System, Image Processing, Radiological LLZ

Proprietary Names

SOMATOM CT Systems with VC50 SW - SOMATOM Perspective, SOMATOM Scope/Scope Power and SOMATOM Emotion 16

Establishment Types

Manufacture Medical Device