FDA.reportPublic FDA data

BIOGRAPH One

Primary DI
04068151020472
Brand
BIOGRAPH One
Company
Siemens Healthineers AG
Model
11689172
Published
2026-01-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPSSystem, tomography, computed, emission
LNHSystem, nuclear magnetic resonance imaging
LNISystem, nuclear magnetic resonance spectroscopic
MOSCoil, magnetic resonance, specialty
OUOTomographic imager combining emission computed tomography with nuclear magnetic resonance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPSSystem, Tomography, Computed, EmissionRadiology2
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2
LNISystem, Nuclear Magnetic Resonance SpectroscopicRadiology2
MOSCoil, Magnetic Resonance, SpecialtyRadiology2
OUOTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic ResonanceRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253023000BIOGRAPH OneSiemens Healthineers AG2026-01-15OUO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04068151020472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04068151020472040681510204724068151020472

GMDN Terms#

Term, Definition table
TermDefinition
PET/MRI systemA diagnostic radiological imaging system that is a combination of a positron emission tomography (PET) camera system for nuclear medicine (NM) images, and a magnetic resonance imaging (MRI) system for magnetic resonance images. The nuclear medicine images and the magnetic resonance images may be registered and displayed in a fused format (overlaid in the same orientation) for the anatomical localization of the nuclear medicine data (i.e., distribution of radiopharmaceuticals). The PET and MRI portions of the system may be used independently or in combination; their images may be transferred to other systems for additional processing.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)888-7436CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
314699460
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04068151034202syngo Dynamics11708404117084042026-07-16
04068151086584LungMapsVA10AVA10A2026-06-24
04068151994995SOMATOM X.cite113300012026-04-07
04068151995008System SOMATOM X.ceed113300022026-04-07
04068151995114MAGNETOM Altea113449152026-02-23
04068151995121MAGNETOM Altea114103712026-02-23
04068151995251MAGNETOM Lumina113449162026-02-23
04068151995268MAGNETOM Lumina115161532026-02-23
04068151995299MAGNETOM Sola112914552026-02-23
04068151995305MAGNETOM Sola114102312026-02-23
04068151995312MAGNETOM Sola Fit114104822026-02-23
04068151995343MAGNETOM Vida110608152026-02-23
04068151995350MAGNETOM Vida115161522026-02-23
04068151995367MAGNETOM Vida Fit115161522026-02-23
04068151995374MAGNETOM Viato.Mobile116896522026-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850042098172MRI Receive Coil (Receive Only)Promaxo LLCMOS2026-10-19
00850042098196Fiducial CoilPromaxo LLCMOS2026-10-19
B133NEUROQ412610120NeuroQSYNTERMED INCORPORATEDKPS2026-10-15
00860013868918MICSI-PETMicroStructure Imaging, Inc.KPS2026-10-14
00198953007716NAGE Medical Systems, L.L.C.LNI2026-10-07
00198953007716NAGE Medical Systems, L.L.C.MOS2026-10-07
00198953007716NAGE Medical Systems, L.L.C.LNH2026-10-07
001989530665533.0T AIR PA XLUSA INSTRUMENTS, INC.MOS2026-10-07
00884838129924AV Cardiovascular Suite V1Philips Medical Systems Nederland B.V.LNH2026-08-23
00816396022676WGS-100 Respiration PillowIVY BIOMEDICAL SYSTEMS, INC.LNH2026-08-03
00816396023550WGS-100 Wireless Gating SystemIVY BIOMEDICAL SYSTEMS, INC.LNH2026-08-03
00816396023567WGS-100 TransmitterIVY BIOMEDICAL SYSTEMS, INC.LNH2026-08-03
00816396023574WGS-100 Base StationIVY BIOMEDICAL SYSTEMS, INC.LNH2026-08-03
07090042059091nordicAktivaNordicneurolab ASLNH2026-08-03
07649998522014NeuroLFPositrigo AGKPS2026-07-28
07649998522021NeuroLFPositrigo AGKPS2026-07-28
07649998522038NeuroLFPositrigo AGKPS2026-07-28
07649998522045NeuroLFPositrigo AGKPS2026-07-28
00866463000496STAGESpintech, Inc.LNH2026-07-23
00850040177145UltraSPECTUltraspect Usa, LLCKPS2026-07-08
B133ECTB422606160Cardiac ToolboxSYNTERMED INCORPORATEDKPS2026-07-02
00884838111622Smart Fit Shoulder 1.5TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
00884838112667Smart Fit Knee 3.0TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
00884838131866Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
00884838133235dS MSK M 1.5TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
00884838133242dS MSK S 1.5TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
04068151086584LungMapsSiemens Healthineers AGLNH2026-06-24
B133NEUROQ412605150NeuroQSYNTERMED INCORPORATEDKPS2026-06-10
04573596201367OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201398OASISFUJIFILM CORPORATIONLNH2026-05-29