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510(k) K253023

Device
BIOGRAPH One
Applicant
Siemens Healthineers AG
510(k) number
K253023
Product code
OUO
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-15
Date received
2025-09-19
Regulation
892.1200
Classification name
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Friederike Hertle
Address
Siemensstr. 3 Forchheim DE 91301 91301

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OUO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K234154uPMR 790Shanghai United Imaging Healthcare Co., Ltd.2024-05-24
K222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.2022-11-14
K213709SIGNA PET/MRGe Medical Systems, LLC2022-01-20
K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc.2020-05-11
K192672uPMR 790Shanghai United Imaging Healthcare Co., Ltd.2019-11-20
K183014uPMR 790Shanghai United Imaging Healthcare Co., Ltd.2019-02-27
K172531Biograph mMR with mMR Angio Transfer OptionSiemens Medical Solutions USA, Inc.2017-11-14
K163234Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc.2017-02-28
K163619SIGNA PET/MRGe Medical Systems, LLC2017-02-14
K142098SIGNA PET/MRGe Medical Systems, LLC2014-11-24
K133226BIOGRAPH MMRSiemens Medical Solutions USA, Inc.2013-11-12
K103483INGENUITY TF PET/MRPhilips Healthcare (Cleveland)2011-11-23
K103429BIOGRAPH MMRSiemens Medical Solutions USA, Inc.2011-06-08