FDA Registration Active 🇺🇸 United States

SIEMENS MEDICAL SOLUTIONS USA, INC.

Reg #: 1034973 · FEI: 1034973 · Expires 2026
Products
3
Proprietary Names
123
Establishment Types
2
Classifications
3

Registration Details

Registration Name
SIEMENS MEDICAL SOLUTIONS USA, INC.
Registration Number
1034973
FEI Number
1034973
Status
Active
Expiry Year
2026
Initial Importer
No
Address
810 INNOVATION DR.
City
KNOXVILLE
State
TN
ZIP
37932
Country
US

Regulatory Submissions

510(k) Number
K170904

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, Tomography, Computed, Emission KPS
System, X-Ray, Tomography, Computed JAK
Source, Calibration, Sealed, Nuclear IXD

Proprietary Names

Biograph Horizon Biograph Horizon - VJ20 Biograph Horizon - 3R Biograph Horizon - 4R LS-LA / LS-Art Line Source ASM Line Source MR-PET ASM SRC LS-Exact Line SRCS ASM Line SRC LS-30 HRRT SRC CS-HT-27-2 Uniform Phantom ASM CS-10-14 Calibration Source CS-27 Uniform Phantom mMR Line Source CS-20-1 Uniform Phantom LS-Exact Line Source LS-15 Line Source CS-7 Uniform Phantom LS-Accel Line Source mMR QC Phantom (CS-mMR) LS-HR+ Line Source LS-30 Line Source CS-20-3 Uniform Phantom CS-20-2 Uniform Phantom Biograph mCT S (20)-4R Biograph mCT 20 Excel Biograph mCT Flow Edge-3R Biograph mCT Flow 64-4R Biograph mCT S Biograph mCT X-4R Biograph mCT Flow 64 Biograph mCT S(64)-3R Biograph mCT S 20 Excel Biograph mCT Flow 40 Biograph mCT Flow 64-3R Biograph mCT Flow 20 Biograph mCT S (20)-3R Biograph mCT S(64)-4R Biograph mCT Biograph mCT Flow Edge-4R Biograph mCT Flow Biograph mCT S(40)-4R Biograph mCT Flow 20-3R Biograph mCT Flow Edge Biograph mCT S(20)-3R (aka Biograph mCT Excel) Biograph mCT Flow 40-4R Biograph mCT X Biograph mCT X-3R Biograph mCT S(40)-3R Biograph mCT Flow 40-3R Biograph mCT Flow 20-4R Biograph mCT - VG60 Biograph mCT S(20)-4R Biograph Vision 450 Biograph mCT - VG80 Biograph Vision 600 Biograph mCT S(20)-3R BIograph mCT S Biograph Vision 600 Edge Biograph Vision - VG80 Biograph Vision 450 Edge Biograph Vision Quadra Biograph Vision Quadra VR10 Biograph mCT S (20) - 4R Biograph mCT Flow Edge - 4R Biograph Vision SOTA Biograph mCT S (20) - 3R Biograph mCT Flow Edge - 3R Biograph mCT X - 4R Biograph mCT S (64) - 4R Biograph mCT Flow 64 - 4R Biograph mCT Flow 20 - 4R Biograph mCT S (40) - 4R Biograph mCT Flow 20 - 3R Biograph mCT X - 3R Biograph mCT S (64) - 3R Biograph Vision Quantum Biograph Vision Peak Biograph mCT Flow 64 - 3R Biograph mCT Flow 40 - 4R Biograph mCT S (40) - 3R Biograph mCT Flow 40 - 3R Biograph Mission P Biograph Mission X Biograph Trinion.X EP9 CT128 Biograph Trinion.X EP5 CT64 Biograph Trinion.X EP5 CT128 Biograph Trinion.X EP9 CT64 Biograph Trinion EP CT128 Biograph Mission T Biograph Trinion EP2 CT128 Biograph Trinion EP CT64 Biograph Trinion EP2 CT64 Biograph Mission S Biograph Vision.X Edge Biograph Vision.X Biograph Vision 600 (8 Ring/64 CT) Biograph Vision 600 Edge (8 Ring/Edge) Biograph VIsion 600 Biograph mCT - VG30 Biograph mCT Excel Biograph Vision Biograph Horizon - VJ30 Biograph mCT - VG70 Biograph 16 TP-3R Biograph 40 TruePoint w/TrueV Biograph 16 TruePoint w/TrueV Biograph TruePoint Biograph 6 TruePoint w/TrueV Biograph 64 TP-3R Biograph 16 TruePoint Biograph 64 TP-4R Biograph 6 TP-3R Biograph 16 TP-4R Biograph 64 TruePoint Biograph 40 TP-4R Biograph 64 TruePoint w/TrueV Biograph 40 TP-3R Biograph 40 TruePoint Biograph 6 TP-4R Biograph 6 TruePoint Biograph Vision Quadra VR20 Biograph Horizon - VJ10 Biograph mCT - VG40 Biograph VK10

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device