FDA 510(k)

Preview Shoulder

K-Number: K210556 · 2021-04-21

Decision Date2021-04-21

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Preview Shoulder is the device name listed in this FDA 510(k) record. The listed applicant is Genesis Software Innovations. It received FDA 510(k) clearance on 2021-04-21 under 510(k) number K210556. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Preview Shoulder?

Preview Shoulder is a medical device that received FDA 510(k) clearance on 2021-04-21. The listed applicant is Genesis Software Innovations. The 510(k) number is K210556.

When did Preview Shoulder receive FDA 510(k) clearance?

Preview Shoulder received FDA 510(k) clearance on 2021-04-21, under 510(k) number K210556.

Who is the listed applicant for Preview Shoulder?

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

What is the FDA product code for Preview Shoulder?

The FDA product code for Preview Shoulder is QIH.

Other records listing Genesis Software Innovations 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.

K240172Preview Shoulder

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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.