FDA 510(k)

ACUSON NX2 Diagnostic Ultrasound Systems

Numéro K : K161787 · 2016-07-28

DemandeurSiemens Medical Solutions USA, Inc.

Date de décision2016-07-28

Code produitIYN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

ACUSON NX2 Diagnostic Ultrasound Systems 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 2016-07-28 under 510(k) number K161787. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the ACUSON NX2 Diagnostic Ultrasound Systems?

ACUSON NX2 Diagnostic Ultrasound Systems is a medical device that received FDA 510(k) clearance on 2016-07-28. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K161787.

When did ACUSON NX2 Diagnostic Ultrasound Systems receive FDA 510(k) clearance?

ACUSON NX2 Diagnostic Ultrasound Systems received FDA 510(k) clearance on 2016-07-28, under 510(k) number K161787.

Who is the listed applicant for ACUSON NX2 Diagnostic Ultrasound Systems?

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 NX2 Diagnostic Ultrasound Systems?

The FDA product code for ACUSON NX2 Diagnostic Ultrasound Systems is IYN.

Essais cliniques associés

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Dispositifs connexes (Code : IYN)

Source officielle

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