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FDA 510(k)

MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM

K-Number: K081121 · 2008-06-04

ApplicantSiemens Medical Solutions USA, Inc., Ultrasound DI
Decision Date2008-06-04
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc., Ultrasound DI. It received FDA 510(k) clearance on 2008-06-04 under 510(k) number K081121. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM?

MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2008-06-04. The listed applicant is Siemens Medical Solutions USA, Inc., Ultrasound DI. The 510(k) number is K081121.

When did MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM received FDA 510(k) clearance on 2008-06-04, under 510(k) number K081121.

Who is the listed applicant for MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc., Ultrasound DI as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM?

The FDA product code for MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM is IYO.

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Other records listing Siemens Medical Solutions USA, Inc., Ultrasound DI as applicant

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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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