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FDA 510(k)

ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM

K-Number: K093531 · 2009-12-01

ApplicantSiemens Medi Cal Solutions, Inc.
Decision Date2009-12-01
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medi Cal Solutions, Inc.. It received FDA 510(k) clearance on 2009-12-01 under 510(k) number K093531. 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 MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM?

ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2009-12-01. The listed applicant is Siemens Medi Cal Solutions, Inc.. The 510(k) number is K093531.

When did ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM receive FDA 510(k) clearance?

ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance on 2009-12-01, under 510(k) number K093531.

Who is the listed applicant for ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM?

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

What is the FDA product code for ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA product code for ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM is 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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