FDA 510(k)

TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS

K-Number: K112953 · 2012-02-03

Decision Date2012-02-03

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS is the device name listed in this FDA 510(k) record. The listed applicant is Teratech Corp.. It received FDA 510(k) clearance on 2012-02-03 under 510(k) number K112953. 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 TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS?

TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS is a medical device that received FDA 510(k) clearance on 2012-02-03. The listed applicant is Teratech Corp.. The 510(k) number is K112953.

When did TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS receive FDA 510(k) clearance?

TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS received FDA 510(k) clearance on 2012-02-03, under 510(k) number K112953.

Who is the listed applicant for TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS?

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

What is the FDA product code for TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS?

The FDA product code for TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS is IYN.

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Other records listing Teratech Corp. as applicant

K131209TERASON USMART3200T ULTRASOUND SYSTEM K110482PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS K110020TERASON T3200 ULTRASOUND SYSTEM K080234TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO K051334TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLER K043278TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES

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Related Devices (Code: IYN)

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.