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FDA 510(k)

APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM

K-Number: K103645 · 2011-01-12

ApplicantToshiba Medical Systems Corporation, Japan
Decision Date2011-01-12
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

APLIO XG 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 2011-01-12 under 510(k) number K103645. 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 APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM?

APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2011-01-12. The listed applicant is Toshiba Medical Systems Corporation, Japan. The 510(k) number is K103645.

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

APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance on 2011-01-12, under 510(k) number K103645.

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

The FDA product code for APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM is ITX.

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Other records listing Toshiba Medical Systems Corporation, Japan as applicant

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Related Devices (Code: ITX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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