FDA 510(k)

VirtuOst

K-Number: K220402 · 2023-05-19

Decision Date2023-05-19

Product CodeKGI

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

VirtuOst is the device name listed in this FDA 510(k) record. The listed applicant is O.N. Diagnostics. It received FDA 510(k) clearance on 2023-05-19 under 510(k) number K220402. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VirtuOst?

VirtuOst is a medical device that received FDA 510(k) clearance on 2023-05-19. The listed applicant is O.N. Diagnostics. The 510(k) number is K220402.

When did VirtuOst receive FDA 510(k) clearance?

VirtuOst received FDA 510(k) clearance on 2023-05-19, under 510(k) number K220402.

Who is the listed applicant for VirtuOst?

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

What is the FDA product code for VirtuOst?

The FDA product code for VirtuOst is KGI.

Other records listing O.N. Diagnostics 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.

K171435VirtuOst Vertebral Fracture Assessment

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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.