Who else makes this device?

Name: VirtuOst
Brand: VirtuOst

Radiology › DiagnosticDensitometer, Bone

VirtuOst

VirtuOst uses data from computed tomography scans to estimate bone mineral density, bone strength, and a load-to-strength ratio. This information can be used by a physician to assess…

Registry build 21.09.26

VirtuOst uses data from computed tomography scans to estimate bone mineral density, bone strength, and a load-to-strength ratio. This information can be used by a physician to assess fracture risk, identify osteoporosis, and monitor therapy. For pediatric patients, VirtuOst provides these estimates without any classifications and should be used only when the benefit of obtaining these estimates outweighs the risk of radiation.

1manufacturer

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Registered in Beijing.

Chinese manufacturers registered for FDA product code KGI
Manufacturer	City	Province	Registered as	Device types
GE Hangwei Medical Systems Co., Ltd.	Beijing	Beijing	Specification developer	22

Record

Regulatory record for VirtuOst
Listed by	O.N. Diagnostics, LLC, United States
FDA product code	KGI
Device type	Densitometer, Bone
Device class	Class 2
Regulation	21 CFR 892.1170
Establishment	Manufacturer
510(k)	K113725
Record published	2018-08-15
Record revised	2023-12-04 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for VirtuOst
Catalogue number	Size	Status
A		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
TBS iNsight	Medimaps Group SA	6
Prodigy	GE Medical Systems Ultrasound & Primary Care Diagnostics LLC	4
3D-SHAPER	3D-SHAPER Medical S.L.	2
QCT PRO Asynchronous 3D Spine and CTXA-Hip System	Mindways Software, Inc.	2
Densitometer, Bone	Stratec Medizintechnik Gmbh	2
Horizon Ci	Hologic, Inc.	1
QCT Pro Asynchronous Calibration Module, CliniQCT	Mindways Software, Inc.	1
XR-600 Basic	Norland at Swissray	1
Discovery A	Hologic, Inc.	1
Medimaps TBS iNsight	Medimaps Group SA	1
Model 4 CT Calibration Phantom	Mindways Software, Inc.	1
Discovery SL	Hologic, Inc.	1

Showing 12 of 38. All products under Densitometer, Bone

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K220402	2023-05-19
K113725	2012-09-13

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.