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FDA 510(k)

Biograph mMR with syngo MR E11P-AP01 system software

K-Number: K200213 · 2020-05-11

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2020-05-11
Product CodeOUO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Biograph mMR with syngo MR E11P-AP01 system software is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2020-05-11 under approval number K200213. The device is classified under product code OUO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biograph mMR with syngo MR E11P-AP01 system software?

Biograph mMR with syngo MR E11P-AP01 system software is a medical device that received FDA 510(k) clearance on 2020-05-11. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K200213.

When was Biograph mMR with syngo MR E11P-AP01 system software approved by the FDA?

Biograph mMR with syngo MR E11P-AP01 system software received FDA 510(k) clearance on 2020-05-11, under approval number K200213.

What company makes Biograph mMR with syngo MR E11P-AP01 system software?

Biograph mMR with syngo MR E11P-AP01 system software is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for Biograph mMR with syngo MR E11P-AP01 system software?

The FDA product code for Biograph mMR with syngo MR E11P-AP01 system software is OUO.

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Other Devices by Siemens Medical Solutions USA, Inc.

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Related Devices (Code: OUO)

K172531Biograph mMR with mMR Angio Transfer OptionSiemens Medical Solutions USA, Inc. K163234Biograph mMR with syngo MR E11P system softwareSiemens Medical Solutions USA, Inc. K163619SIGNA PET/MRGe Medical Systems, LLC K192672uPMR 790Shanghai United Imaging Healthcare Co., Ltd. K183014uPMR 790Shanghai United Imaging Healthcare Co., Ltd. K222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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