FDA 510(k)

BIOGRAPH MCT FAMILY

K-Number: K123737 · 2013-01-29

ApplicantSiemens Medical Solutions USA, Inc.

Decision Date2013-01-29

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BIOGRAPH MCT FAMILY 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 2013-01-29 under 510(k) number K123737. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOGRAPH MCT FAMILY?

BIOGRAPH MCT FAMILY is a medical device that received FDA 510(k) clearance on 2013-01-29. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K123737.

When did BIOGRAPH MCT FAMILY receive FDA 510(k) clearance?

BIOGRAPH MCT FAMILY received FDA 510(k) clearance on 2013-01-29, under 510(k) number K123737.

Who is the listed applicant for BIOGRAPH MCT FAMILY?

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 MCT FAMILY?

The FDA product code for BIOGRAPH MCT FAMILY is KPS.

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Official Source

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