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
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