FDA 510(k)

APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM

K-Number: K121577 · 2012-06-22

ApplicantToshiba Medical Systems Corporation, Japan

Decision Date2012-06-22

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba Medical Systems Corporation, Japan. It received FDA 510(k) clearance on 2012-06-22 under 510(k) number K121577. 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 APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM?

APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2012-06-22. The listed applicant is Toshiba Medical Systems Corporation, Japan. The 510(k) number is K121577.

When did APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM receive FDA 510(k) clearance?

APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance on 2012-06-22, under 510(k) number K121577.

Who is the listed applicant for APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA 510(k) record lists Toshiba Medical Systems Corporation, Japan as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA product code for APLIO ARTIDA 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.