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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 the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2020-05-11 under 510(k) 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. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K200213.

When did Biograph mMR with syngo MR E11P-AP01 system software receive FDA 510(k) clearance?

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

Who is the listed applicant for Biograph mMR with syngo MR E11P-AP01 system software?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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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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