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FDA 510(k)

APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0

K-Number: K063130 · 2006-11-02

Decision Date2006-11-02
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2006-11-02 under 510(k) number K063130. 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 XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0?

APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0 is a medical device that received FDA 510(k) clearance on 2006-11-02. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K063130.

When did APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0 receive FDA 510(k) clearance?

APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0 received FDA 510(k) clearance on 2006-11-02, under 510(k) number K063130.

Who is the listed applicant for APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0?

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

What is the FDA product code for APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0?

The FDA product code for APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0 is IYN.

Related Clinical Trials

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.

Other records listing Toshibamedical Systems Corporation as applicant

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.

View all 52 devices →

Related Devices (Code: IYN)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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