FDA 510(k)

Terason uSmart3200T Ultrasound System

K-Number: K193510 · 2020-01-28

Decision Date2020-01-28

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Terason uSmart3200T Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Teratech Corporation. It received FDA 510(k) clearance on 2020-01-28 under 510(k) number K193510. 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 uSmart3200T Ultrasound System?

Terason uSmart3200T Ultrasound System is a medical device that received FDA 510(k) clearance on 2020-01-28. The listed applicant is Teratech Corporation. The 510(k) number is K193510.

When did Terason uSmart3200T Ultrasound System receive FDA 510(k) clearance?

Terason uSmart3200T Ultrasound System received FDA 510(k) clearance on 2020-01-28, under 510(k) number K193510.

Who is the listed applicant for Terason uSmart3200T Ultrasound System?

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

What is the FDA product code for Terason uSmart3200T Ultrasound System?

The FDA product code for Terason uSmart3200T Ultrasound System is IYN.

Other records listing Teratech 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.

K201633Terason uSmart 3200T Plus Ultrasound System

Related Devices (Code: IYN)

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.