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FDA 510(k)

ACUSON X800 Diagnostic Ultrasound System

K-Number: K180067 · 2018-02-07

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2018-02-07
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACUSON X800 Diagnostic Ultrasound System is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2018-02-07 under approval number K180067. 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 X800 Diagnostic Ultrasound System?

ACUSON X800 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2018-02-07. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K180067.

When was ACUSON X800 Diagnostic Ultrasound System approved by the FDA?

ACUSON X800 Diagnostic Ultrasound System received FDA 510(k) clearance on 2018-02-07, under approval number K180067.

What company makes ACUSON X800 Diagnostic Ultrasound System?

ACUSON X800 Diagnostic Ultrasound System is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for ACUSON X800 Diagnostic Ultrasound System?

The FDA product code for ACUSON X800 Diagnostic Ultrasound System is IYN.

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Related Devices (Code: IYN)

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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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