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FDA 510(k)

ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE

K-Number: K121076 · 2012-10-09

ApplicantToshiba America Medical Systems, In.C
Decision Date2012-10-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba America Medical Systems, In.C. It received FDA 510(k) clearance on 2012-10-09 under 510(k) number K121076. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE?

ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE is a medical device that received FDA 510(k) clearance on 2012-10-09. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K121076.

When did ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE receive FDA 510(k) clearance?

ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE received FDA 510(k) clearance on 2012-10-09, under 510(k) number K121076.

Who is the listed applicant for ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE?

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

What is the FDA product code for ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE?

The FDA product code for ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE is LLZ.

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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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