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FDA 510(k)

FUJIFILM Sonosite Vevo MD Imaging System

K-Number: K190476 · 2019-03-15

Decision Date2019-03-15
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Sonosite Vevo MD Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Sonosite, Inc.. It received FDA 510(k) clearance on 2019-03-15 under 510(k) number K190476. 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 FUJIFILM Sonosite Vevo MD Imaging System?

FUJIFILM Sonosite Vevo MD Imaging System is a medical device that received FDA 510(k) clearance on 2019-03-15. The listed applicant is FUJIFILM Sonosite, Inc.. The 510(k) number is K190476.

When did FUJIFILM Sonosite Vevo MD Imaging System receive FDA 510(k) clearance?

FUJIFILM Sonosite Vevo MD Imaging System received FDA 510(k) clearance on 2019-03-15, under 510(k) number K190476.

Who is the listed applicant for FUJIFILM Sonosite Vevo MD Imaging System?

The FDA 510(k) record lists FUJIFILM Sonosite, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUJIFILM Sonosite Vevo MD Imaging System?

The FDA product code for FUJIFILM Sonosite Vevo MD Imaging System is IYN.

Other records listing FUJIFILM Sonosite, Inc. 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.

View all 19 devices →

Related Devices (Code: IYN)

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.

Official Source

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