FDA 510(k)

Interson USB Ultrasound System

K-Number: K163443 · 2017-04-13

Decision Date2017-04-13

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Interson USB Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Interson Corporation. It received FDA 510(k) clearance on 2017-04-13 under 510(k) number K163443. 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 Interson USB Ultrasound System?

Interson USB Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-04-13. The listed applicant is Interson Corporation. The 510(k) number is K163443.

When did Interson USB Ultrasound System receive FDA 510(k) clearance?

Interson USB Ultrasound System received FDA 510(k) clearance on 2017-04-13, under 510(k) number K163443.

Who is the listed applicant for Interson USB Ultrasound System?

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

What is the FDA product code for Interson USB Ultrasound System?

The FDA product code for Interson USB Ultrasound System is IYN.

Other records listing Interson 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.

K233734Interson USB 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.