Cleared Traditional

VIRTUOST

K113725 · O.N. Diagnostics · Radiology
Sep 2012
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K113725 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 September 13, 2012, 269 days after receiving the submission on December 19, 2011. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1170.

Submission Details

510(k) Number K113725 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2011
Decision Date September 13, 2012
Days to Decision 269 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