FDA 510(k)

SoftVue

K-Number: K172256 · 2018-03-02

Decision Date2018-03-02

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SoftVue is the device name listed in this FDA 510(k) record. The listed applicant is Delphinus Medical Technologies. It received FDA 510(k) clearance on 2018-03-02 under 510(k) number K172256. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SoftVue?

SoftVue is a medical device that received FDA 510(k) clearance on 2018-03-02. The listed applicant is Delphinus Medical Technologies. The 510(k) number is K172256.

When did SoftVue receive FDA 510(k) clearance?

SoftVue received FDA 510(k) clearance on 2018-03-02, under 510(k) number K172256.

Who is the listed applicant for SoftVue?

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

What is the FDA product code for SoftVue?

The FDA product code for SoftVue is IYO.

Other records listing Delphinus Medical Technologies as applicant

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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.