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VirtuOst Bone Densitometer

by O.N. Diagnostics 2 variants

510(k) K113725

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK113725 Date13 Sep 2012ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Virtuost
510(k) Number
FDA product code
KGI
Device class
Class II
Regulation
21 CFR Part 892.1170
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The VirtuOst Bone Densitometer is a medical device classified as a bone densitometer, designed to estimate bone mineral density, bone strength, and load-to-strength ratios. It processes data from computed tomography (CT) scans to provide quantitative assessments of bone health, aiding in fracture risk assessment, osteoporosis identification, and therapeutic monitoring. This device leverages existing CT imaging to derive clinically relevant metrics without requiring additional scans, making it a non-invasive diagnostic tool for radiology applications.

The VirtuOst is supplied as a software-based solution integrated with CT imaging systems, intended for use in radiology settings. It is not classified as single-use or reusable but operates as a standalone analytical tool. The device adheres to FDA 510(k) clearance (K113725) under the Radiology advisory committee, with regulatory classification as a Class II device (892.1170). No specific sterility or MRI safety information is provided, and its use is restricted to qualified healthcare professionals for diagnostic interpretation.

Devices cleared under K113725

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K113725
UDI-DISize and differences
VirtuOst A
O.N. Diagnostics
A00860000233101 —On the market

Similar devices

Other devices filed under FDA product code KGI (Densitometer, Bone).

Other devices from O.N. Diagnostics