Cleared Traditional

VirtuOst

K220402 · O.N. Diagnostics · Radiology
May 2023
Decision
462d
Days
Class 2
Risk

About This 510(k) Submission

K220402 is an FDA 510(k) clearance for the VirtuOst, a Densitometer, Bone (Class II — Special Controls, product code KGI), submitted by O.N. Diagnostics (Berkeley, US). The FDA issued a Cleared decision on May 19, 2023, 462 days after receiving the submission on February 11, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1170.

Submission Details

510(k) Number K220402 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 2022
Decision Date May 19, 2023
Days to Decision 462 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KGI — Densitometer, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1170