TBS iNsight

GUDID B214OSTBSIV400

TBS iNsight is a software application provided for use as a complement to bone mineral density (BMD) acquired from dual energy X-ray absorptiometry (DXA) and other clinical risk factors for osteoporosis and fragility fracture. It calculates a score (Trabecular Bone Score - TBS) derived from the texture of the DXA image of the anterior-posterior (AP) lumbar spine and has been shown to be related to bone microarchitecture. The method analyzes X-ray based images acquired by DXA imaging systems and produces the TBS based on the computation of an Adapted Experimental Variogram (modified fractal-like approach). This variogram is used to measure the degree of spatial variation between pairs of data points in a spatial dimension of a region of a digital image.

medimaps group SA

Basic diagnostic x-ray system application software

• Primary Device ID: B214OSTBSIV400
• NIH Device Record Key: 4b2e02ef-c369-4529-9ac9-3b8719fc51ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TBS iNsight
• Version Model Number: 4.0
• Company DUNS: 486330728
• Company Name: medimaps group SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 608 669 9113
• Email: clientcare@medimapsgroup.com
• Phone: +1 608 669 9113
• Email: clientcare@medimapsgroup.com
• Phone: +1 608 669 9113
• Email: clientcare@medimapsgroup.com
• Phone: +1 608 669 9113
• Email: clientcare@medimapsgroup.com
• Phone: +1 608 669 9113
• Email: clientcare@medimapsgroup.com
• Phone: +1 608 669 9113
• Email: clientcare@medimapsgroup.com
• Phone: +1 608 669 9113
• Email: clientcare@medimapsgroup.com
• Phone: +1 608 669 9113
• Email: clientcare@medimapsgroup.com
• Phone: +1 608 669 9113
• Email: clientcare@medimapsgroup.com
• Phone: +1 608 669 9113
• Email: clientcare@medimapsgroup.com
• Phone: +1 608 669 9113
• Email: clientcare@medimapsgroup.com
• Phone: +1 608 669 9113
• Email: clientcare@medimapsgroup.com
• Phone: +1 608 669 9113
• Email: clientcare@medimapsgroup.com
• Phone: +1 608 669 9113
• Email: clientcare@medimapsgroup.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B214OSTBSIV400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243218

FDA Product Code

• KGI: Densitometer, Bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-21
• Device Publish Date: 2025-02-13

Devices Manufactured by medimaps group SA

• B214OSTBSIV400 - TBS iNsight: 2025-02-21TBS iNsight is a software application provided for use as a complement to bone mineral density (BMD) acquired from dual energy X-ray absorptiometry (DXA) and other clinical risk factors for osteoporosis and fragility fracture. It calculates a score (Trabecular Bone Score - TBS) derived from the texture of the DXA image of the anterior-posterior (AP) lumbar spine and has been shown to be related to bone microarchitecture. The method analyzes X-ray based images acquired by DXA imaging systems and produces the TBS based on the computation of an Adapted Experimental Variogram (modified fractal-like approach). This variogram is used to measure the degree of spatial variation between pairs of data points in a spatial dimension of a region of a digital image.
• B214OSTBSIV400 - TBS iNsight: 2025-02-21 TBS iNsight is a software application provided for use as a complement to bone mineral density (BMD) acquired from dual energy X
• B214OSPTM3 - Phantom: 2023-10-04