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FDA 510(k)

THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM

K-Number: K103722 · 2011-01-05

ApplicantMedison Co., Ltd.
Decision Date2011-01-05
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medison Co., Ltd.. It received FDA 510(k) clearance on 2011-01-05 under 510(k) number K103722. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM?

THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2011-01-05. The listed applicant is Medison Co., Ltd.. The 510(k) number is K103722.

When did THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM receive FDA 510(k) clearance?

THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance on 2011-01-05, under 510(k) number K103722.

Who is the listed applicant for THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA 510(k) record lists Medison Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA product code for THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM is ITX.

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Related Devices (Code: ITX)

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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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