TBS iNsight

Primary DI
B214OSTBSI30
Brand
TBS iNsight
Company
medimaps group SA
Model
3.0.2.0
Device description
TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age-matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture. TBS provides information independent of BMD value; it is used as a complement to the data obtained from the DXA analysis and the clinical examination. The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk.
Published
2017-02-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGIDensitometer, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGIDensitometer, BoneRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B214OSTBSI0PreviousHIBCC0
B214OSTBSI30PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone absorptiometric x-ray system, dual-energyAn assembly of devices designed for bone density measurements and other calculations based on data obtained using a two distinct photon energy peak. Also referred to as a bone densitometer. It utilizes an x-ray tube or tubes as the photon source which are mechanically aligned and moves along with a photon detector assembly typically in a rectilinear pattern. The collimated beam is directed through an anatomical region of interest and the differential absorption patterns are detected. This information is used in calculations to estimate bone mineral density (osteoporosis), subcutaneous fat, fracture risk.

Contacts#

Phone, Email table
PhoneEmail
+1-608-669-9113support@medimapsgroup.com

Regulatory Flags#

DUNS number
486330728
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B214OSPTMV30Phantom32022-12-08
B214OSTBSIV400TBS iNsight4.02025-02-13
B214OSPTM3Phantom32022-12-08
B214OSTBSI3120TBS iNsight3.1.22022-01-13
B214OSTBSI3110TBS iNsight3.1.12020-06-25
B214OSTBSI3100TBS iNsight3.1.02020-02-28
B214OSTBSI0Medimaps TBS iNsight3.0.1.02016-07-12
B214OSTBSI303TBS iNsight3.0.3.02018-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
084370217400663D-SHAPER3D-SHAPER MEDICAL S.L.KGI2026-05-12
B214OSTBSIV400TBS iNsightmedimaps group SAKGI2025-02-13
084370217400283D-SHAPER3D-SHAPER MEDICAL S.L.KGI2023-10-04
B052PHCTM40Model 4 CT Calibration PhantomMINDWAYS SOFTWARE, INC.KGI2023-05-04
B214OSPTMV30Phantommedimaps group SAKGI2022-12-08
B214OSPTM3Phantommedimaps group SAKGI2022-12-08
B214OSTBSI3120TBS iNsightmedimaps group SAKGI2022-01-13
00866955000478IlluminatusDXA SoftwareNorland at SwissrayKGI2020-07-27
B214OSTBSI3110TBS iNsightmedimaps group SAKGI2020-06-25
B214OSTBSI3100TBS iNsightmedimaps group SAKGI2020-02-28
B214OSTBSI303TBS iNsightmedimaps group SAKGI2018-08-30
00860000233101VirtuOstO N DIAGNOSTICS LLCKGI2018-08-15
00840682138345ProdigyGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCKGI2018-07-03
00840682138352ProdigyGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCKGI2018-07-03
15420045507494APEX Practice Managment ToolHologic, Inc.KGI2018-04-04
00866955000409XR-600 Basic Norland at SwissrayKGI2017-11-16
00866955000416XR-600 Clinical Norland at SwissrayKGI2017-11-16
00866955000423XR-600 AdvancedNorland at SwissrayKGI2017-11-16
00866955000430XR-800 BasicNorland at SwissrayKGI2017-11-16
00866955000447XR- 800 ClinicalNorland at SwissrayKGI2017-11-16
00866955000454XR-800 AdvancedNorland at SwissrayKGI2017-11-16
00866955000461EliteNorland at SwissrayKGI2017-11-16
15420045506893Discovery SLHologic, Inc.KGI2017-11-15
15420045506909Discovey CHologic, Inc.KGI2017-11-15
15420045506916Discovery WHologic, Inc.KGI2017-11-15
15420045506879Discovery AHologic, Inc.KGI2017-09-22
04260491560018NAStratec Medizintechnik GmbHKGI2017-04-26
04260491560025NAStratec Medizintechnik GmbHKGI2017-04-26
B052DIASYNC0QCT Pro Asynchronous Calibration Module, CliniQCTMINDWAYS SOFTWARE, INC.KGI2017-03-31
B052DICTXAHIP0CTXA Hip Bone Mineral DensitometerMINDWAYS SOFTWARE, INC.KGI2017-03-31