FDA 510(k)

VistaScan USB Ultrasound Imaging System

Numéro K : K192170 · 2020-01-23

DemandeurEmagine Solutions Technology, LLC

Date de décision2020-01-23

Code produitIYO

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

VistaScan USB Ultrasound Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Emagine Solutions Technology, LLC. It received FDA 510(k) clearance on 2020-01-23 under 510(k) number K192170. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the VistaScan USB Ultrasound Imaging System?

VistaScan USB Ultrasound Imaging System is a medical device that received FDA 510(k) clearance on 2020-01-23. The listed applicant is Emagine Solutions Technology, LLC. The 510(k) number is K192170.

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

VistaScan USB Ultrasound Imaging System received FDA 510(k) clearance on 2020-01-23, under 510(k) number K192170.

Who is the listed applicant for VistaScan USB Ultrasound Imaging System?

The FDA 510(k) record lists Emagine Solutions Technology, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VistaScan USB Ultrasound Imaging System?

The FDA product code for VistaScan USB Ultrasound Imaging System is IYO.

Essais cliniques associés

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Source officielle

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