Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1034973

FEI Number

1034973

Entity Name

SIEMENS MEDICAL SOLUTIONS USA, INC.

City/State/Country

KNOXVILLE, TN, US

Establishment Address

810 INNOVATION DR., KNOXVILLE, TN 37932, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K173578

PMA Number

N/A

All Registered 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 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 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 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 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 Edge Biograph Vision 600 (8 Ring/64 CT) Biograph Vision 600 Edge (8 Ring/Edge) Biograph VIsion 600 Biograph mCT - VG30 Biograph mCT X Biograph mCT Excel Biograph mCT S Biograph Vision 450 Edge Biograph Vision Biograph Vision 600 Edge Biograph Vision 600 Biograph Vision 450 Biograph Horizon - VJ30 Biograph Horizon - 3R Biograph Horizon - 4R Biograph Horizon 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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
IXD	Source, Calibration, Sealed, Nuclear	Radiology	Class 1	892.1400	2005-09-07
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	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	2021-03-03
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2021-03-03
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	2025-08-04
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-08-04
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	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	2012-12-26
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2012-12-26
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
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	2018-01-06
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2018-01-06

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
3014745562	Siemens Healthcare s.r.o.	Kosice-Barca Kosicky, SK
3002619337	Siemens Healthineers Ltd.	SEONGNAM-SI Gyeonggi, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033956	Is2 Research, Inc.	MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)	2004-01-20
K923309	GE Medical Systems	ARGUS PET SYSTEM	1992-09-29
K101768	Miegmbh	MIE SCINTRON GAMMA CAMERA SYSTEMS	2010-10-05
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2016	Toshiba American Medical Systems Inc	2	Celesteion PCA-9000A/2 PET/CT System
Z-0012-05	General Electric Med Systems LLC	2	Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam.
Z-0013-2007	Philips Medical Systems (Cleveland) Inc	2	Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 679 75691. Precedence, Model #2169 -3000A, #2169-3001A, #2169-3002A, and 2169-3003A. PET/CT Computed tomography systems.
Z-0014-2007	Philips Medical Systems (Cleveland) Inc	2	Brilliance(a) CT 6 slice, Model #4535 670 73191. Brilliance(a) CT 10 Slice, Model 4535 670 73181. Brilliance 16 Slice, Model #4535 670 78851. Brilliance CT 16 Power, Model #4535 670 23331. Brilliance CT 40 Slice, Model #4550 110 04011. Brilliance CT Big Bore, Model #4535 670 88051. Computed tomography systems.
Z-0024-2014	GE Healthcare, LLC	2	GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1034973. Last updated year: 2026. Please use registration number 1034973 when referencing this establishment in official correspondence.