FDA 510(k)

ACUSON

K-Number: K131164 · 2013-12-24

ApplicantSiemens Medical Solutions USA, Inc.

Decision Date2013-12-24

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ACUSON 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 2013-12-24 under 510(k) number K131164. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUSON?

ACUSON is a medical device that received FDA 510(k) clearance on 2013-12-24. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K131164.

When did ACUSON receive FDA 510(k) clearance?

ACUSON received FDA 510(k) clearance on 2013-12-24, under 510(k) number K131164.

Who is the listed applicant for ACUSON?

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 ACUSON?

The FDA product code for ACUSON is IYN.

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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.