FDA Registration Active 🇺🇸 United States

Biograph mCT-S (64)

Reg #: 1423253 · FEI: 1000514697 · Expires 2025
Products
2
Proprietary Names
26
Establishment Types
1
Classifications
2

Registration Details

Registration Name
SIEMENS MEDICAL SOLUTIONS USA, INC.
Registration Number
1423253
FEI Number
1000514697
Status
Active
Expiry Year
2025
Initial Importer
No
Address
2501 NORTH BARRINGTON RD.
City
Hoffman Estates
State
IL
ZIP
60192
Country
US

Regulatory Submissions

510(k) Number
K123737

Owner / Operator

Firm Name
SIEMENS MEDICAL SOLUTIONS USA, INC.
Operator Number
9002915
Address
40 Liberty Boulevard
City
Malvern
State
PA
Postal Code
19355
Country
US

Products

Device Name Product Code
System, X-Ray, Tomography, Computed JAK
System, Tomography, Computed, Emission KPS

Proprietary Names

Biograph mCT-S (64) Biograph mCT Flow 40 Biograph mCT-S (20) Biograph mCT Flow 64 Biograph mCT Flow Edge Biograph mCT-S (40) Biograph mCT Flow 20 Biograph mCT-X Biograph mCT Flow Edge-4R Biograph mCT S(40)-3R Biograph mCT Flow 20-3R Biograph mCT X-4R Biograph mCT 20 Excel Biograph mCT Flow 64-4R Biograph mCT Flow 40-3R Biograph mCT Flow 64-3R Biograph mCT X-3R Biograph mCT Flow Edge-3R Biograph mCT S(64)-3R Biograph mCT S(40)-4R Biograph mCT Flow 40-4R Biograph mCT Flow 20-4R Biograph mCT S(20)-3R Biograph mCT S (64)-4R Biograph mCT S(20)-4R Biograph mCT - VG50

Establishment Types

Manufacture Medical Device