Medimaps TBS iNsight

Basic Information

• Brand Name: Medimaps TBS iNsight
• Primary DI: B214OSTBSI0
• Version / Model: 3.0.1.0
• Company Name: medimaps group SA
• Labeler DUNS: 486330728
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-12
• Public Version: 4
• Public Version Date: 2023-10-04
• Public Version Status: Update
• Public Device Record Key: 06af12c2-c3c2-46cd-86a2-171951049e93
• Distribution End Date: 2016-10-19

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGI	Densitometer, Bone	Radiology	892.1170	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37661	Bone absorptiometric x-ray system, dual-energy	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B214OSTBSI0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]