Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1423253

FEI Number

1000514697

Entity Name

SIEMENS MEDICAL SOLUTIONS USA, INC.

City/State/Country

Hoffman Estates, IL, US

Establishment Address

2501 NORTH BARRINGTON RD., Hoffman Estates, IL 60192, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SIEMENS MEDICAL SOLUTIONS USA, INC. (Owner Number: 9002915)

Owner / Operator Contact Address

40 Liberty Boulevard, Malvern, PA 19355, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212604

PMA Number

N/A

All Registered Proprietary Names

Biograph Horizon - VJ30 Biograph Horizon - 3R Biograph Horizon - 4R Biograph Horizon Scenium VE10 Scenium Symbia Intevo Bold Symbia 6.5 - VB20 Scenium VD20 Scenium Biograph Vision 600 Edge Biograph Vision 600 (8 Ring/64 CT) Biograph Vision 600 Edge (8 Ring/Edge) Biograph VIsion 600 Biograph mCT S(64)-3R Biograph mCT Flow 40-3R Biograph mCT Flow Edge-3R Biograph mCT Flow 20 Biograph mCT X Biograph mCT Flow 64-3R Biograph mCT X-4R Biograph mCT S(64)-4R Biograph mCT Flow 40-4R Biograph mCT Flow Edge Biograph mCT S 20 Excel Biograph mCT Flow 20-4R Biograph mCT 20 Excel Biograph mCT Flow 20-3R Biograph mCT Flow Biograph mCT S(20)-3R Biograph mCT S(20)-4R Biograph mCT S(40)-4R Biograph mCT Flow 64-4R Biograph mCT - VG70 Biograph mCT Flow 40 Biograph mCT S(40)-3R Biograph mCT X-3R Biograph mCT Flow Edge-4R Biograph mCT S Biograph mCT Flow 64 Biograph mCT Excel Biograph Horizon Biograph Horizon - VJ20 Biograph Horizon - 3R Biograph Horizon - 4R Scenium VE20 syngo.MI Reading (VA30A) syngo.CT LungCAD (VA30A) syngo.NM Reading (VA30A) syngo.MI Workplace syngo.MI Cardiology (VA30A) syngo.MI Taskflows syngo.SPECT Reading (VA30A) syngo.MI Neurology (VA30A) syngo.MM Oncology (VA30A) syngo.via MI Wokflows (VA30A) syngo.PET&CT Oncology (VA30A) syngo Circulation Dynamic PET syngo.PET Myocardial Blood Flow syngo.MBF - CFR 2 syngo.MBF syngo.MI Workplace syngo.MI Cardiology (VB10, VB10A) syngo.via MI Workflows VB10A syngo.via MI Taskflows syngo.MI Reading (VB10, VB10A) (aka syngo.SPECT Reading and / or syngo.NM Reading) syngo.MI Neurology (VB10, VB10A) syngo.PET&CT Oncology (VB10, VB10A) (aka syngo.MM Oncology (VB10, VB10A)) Symbia E Symbia T16 Symbia S Symbia E Single Symbia T6 Symbia T Symbia Evo Symbia Intevo 16 Symbia Intevo 6 Symbia 6.7 Symbia E Dual Symbia T2 Symbia Intevo 2 Symbia Evo Excel Symbia Intevo Bold Symbia Intevo Excel syngo.NM Reading VB30A syngo.MI Reading VB30A syngo.MI Cardiology VB30A syngo.CT LungCAD VB30A syngo.PET&CT Oncology VB30A syngo.MI Neurology VB30A syngo.via MI Neurology VB30A syngo.MM Oncology VB30A syngo.via MI Workflows VB30A syngo.via MI Cardiology VB30A syngo.SPECT Reading VB30A syngo.SPECT Processing VB30A 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 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 Symbia T2 Symbia T6 Symbia E Symbia Evo Symbia T Symbia E Dual Symbia Intevo 2 Symbia Intevo 6 Symbia Intevo Excel Symbia T16 Symbia Evo Excel Symbia E Single Symbia Intevo 16 Symbia S Symbia 6.5 - VB20 Biograph Horizon Biograph Horizon - 4R Biograph Horizon - 3R Biograph Horizon - VJ10 syngo.MI Cardiology syngo.MI General syngo.MI Neurology syngo.NM Reading syngo.via MI Workflows syngo.MM Oncology syngo PET&CT Oncology syngo.via MI Workflows VB60A syngo.via MI Neurology syngo.SPECT Processing syngo.MI Reading 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 Symbia Pro.specta VA20 Symbia Pro.specta X3 Symbia Pro.specta X7 Symbia Pro.specta VA20A Symbia Pro.specta Q3 Biograph mCT Flow Edge-4R Biograph mCT Flow 64 Biograph mCT S(40)-3R Biograph mCT S(20)-4R Biograph mCT X Biograph Vision 450 Biograph mCT Flow 20-4R Biograph mCT Flow 40 Biograph mCT S 20 Excel Biograph mCT X-3R Biograph mCT - VG80 Biograph mCT Flow 64-4R Biograph Vision 600 Biograph mCT Flow 40-4R Biograph mCT Flow 20 Biograph mCT S(40)-4R Biograph mCT Flow 64-3R Biograph mCT Flow 40-3R Biograph mCT Flow 20-3R Biograph mCT 20 Excel Biograph mCT X-4R Biograph mCT Flow Edge Biograph mCT S(20)-3R BIograph mCT S Biograph Vision 600 Edge Biograph Vision - VG80 Biograph mCT Flow Edge-3R Biograph mCT Flow Biograph mCT S(64)-4R Biograph mCT S(64)-3R Biograph Vision 450 Edge Symbia VA10A Symbia Pro.specta X3 Symbia Pro.specta X7 Symbia Pro.specta Q3 Symbia Evo Symbia T16 Symbia T2 Symbia.net Symbia T Symbia Intevo Excel Symbia Intevo 16 Symbia Evo Excel Symbia Intevo 6 Symbia S Symbia VB23 Symbia Intevo Bold Symbia Intevo 2 Symbia T6 Symbia Intevo c.cam Biograph mCT S (20) - 4R Biograph mCT Flow Edge - 4R Biograph Vision SOTA Biograph mCT S (20) - 3R Biograph mCT Flow Edge - 3R Biograph Vision 600 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 Vision 600 Edge Biograph mCT S (64) - 3R Biograph Vision Quantum Biograph Vision 450 Biograph Vision Peak Biograph mCT Flow 64 - 3R Biograph mCT Flow 40 - 4R Biograph mCT S (40) - 3R Biograph Vision 450 Edge Biograph mCT Flow 40 - 3R Biograph mCT S 20 Excel Biograph Vision.X Edge Biograph Vision.X Biograph Trinion EP CT64 Biograph VK10 Biograph Trinion EP2 CT64 Biograph Trinion EP2 CT128 Biograph Trinion EP CT128 Biograph Vision Quadra Biograph Vision Quadra VR10 Biograph Vision 450 Edge Biograph Vision Biograph Vision 600 Edge Biograph Vision 600 Biograph Vision 450 Scenium Scenium Database Comparison syngo.PET Myocardial Blood Flow syngo.MI Neurology VC10 syngo.MI General VC10 syngo MBF syngo.MM Oncology VC10 syngo.NM Organ Processing syngo.NM Organ Processing VC10 syngo.MI Neurology syngo.MI Cardiology syngo.MI General Scenium Cortical Analysis Scenium Subtraction Scenium Striatal Analysis syngo.MI Cardiology VC10 syngo.MM Oncology syngo PET Myocardial Blood Flow syngo.MBF syngo.MI General syngo.MM Oncology syngo.MI Neurology syngo.via MI Workflows Scenium syngo.via MI Workflows VB80A syngo.NM Organ Processing syngo.MI Cardiology Biograph Vision Quadra VR20 Biograph Vision Quadra Symbia Pro.specta FAST Symbia Pro.specta X7 Symbia Pro.specta SHARP Symbia Pro.specta SPEED Symbia Pro.specta VA40 Family Symbia Pro.specta LIGHT Symbia Pro.specta FLOW Symbia Pro.specta Q3 Symbia Pro.specta X3 Symbia VA10A Symbia Pro.specta Q3 Symbia Pro.specta X3 Symbia Pro.specta X7

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2020-02-18
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2020-02-18
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-09-23
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2017-01-10
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2017-01-10
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2015-04-16
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-04-16
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2018-05-24
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2018-05-24
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2018-01-06
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2018-01-06
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2017-06-01
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2017-06-01
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-04-12
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-02-10
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2012-12-26
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-06-26
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2020-03-24
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2020-03-24
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-04-12
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2014-12-22
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2014-12-22
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2025-08-04
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-08-04
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2016-09-09
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2016-09-09
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2016-01-15
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2016-01-15
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-06-17
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2021-06-17
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2015-07-30
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2015-07-30
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2023-05-20
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2023-05-20
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2020-02-18
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2020-02-18
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-05-19
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2021-05-19
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2024-09-06
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-09-06
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2024-02-16
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-07-14
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2025-07-14
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2023-07-25
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2023-07-25
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-01-26
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2024-01-26
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-03-03
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2021-03-03
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2019-05-07
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-05-07
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-07-07
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2023-11-29
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2022-12-23
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2022-12-23
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2026-05-26
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2026-05-26
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2021-11-10
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-11-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SIEMENS MEDICAL SOLUTIONS USA, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1836549	SIEMENS MEDICAL SOLUTIONS USA, INC.	ANN ARBOR, MI, US
3012127758	Siemens Healthcare Limited	Oakville Ontario, CA
2531814	Siemens Medical Solutions USA, Inc.	Plymouth Meeting, PA, US
1034973	SIEMENS MEDICAL SOLUTIONS USA, INC.	KNOXVILLE, TN, US
3014745562	Siemens Healthcare s.r.o.	Kosice-Barca Kosicky, SK

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243523	Siemens Medical Solutions USA, Inc.	NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime	2025-02-12
K781431	General Electric Co.	ELECTRIC CT/T OPERATOR DISPLAY CONSOLE	1978-09-07
K231574	FUJIFILM Healthcare Americas Corporation	Scenaria View 4.2	2023-10-12
K233583	FUJIFILM Healthcare Americas Corporation	FCT iSTREAM Phase 1	2024-04-26
K151376	Covidien, LLC	superDimension Navigation System	2015-11-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2011	GE Medical Systems, LLC	2	HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017	Philips Medical Systems	2	Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017	Philips Medical Systems	2	Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017	Philips Medical Systems	2	Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0012-2017	Philips Medical Systems	2	Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1423253. Last updated year: 2026. Please use registration number 1423253 when referencing this establishment in official correspondence.