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FDA 510(k)

Biograph mMR with mMR Angio Transfer Option

K-Number: K172531 · 2017-11-14

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2017-11-14
Product CodeOUO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Biograph mMR with mMR Angio Transfer Option 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 2017-11-14 under 510(k) number K172531. 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 mMR Angio Transfer Option?

Biograph mMR with mMR Angio Transfer Option is a medical device that received FDA 510(k) clearance on 2017-11-14. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K172531.

When did Biograph mMR with mMR Angio Transfer Option receive FDA 510(k) clearance?

Biograph mMR with mMR Angio Transfer Option received FDA 510(k) clearance on 2017-11-14, under 510(k) number K172531.

Who is the listed applicant for Biograph mMR with mMR Angio Transfer Option?

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 mMR Angio Transfer Option?

The FDA product code for Biograph mMR with mMR Angio Transfer Option 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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