TBS iNsight

GUDID B214OSTBSI3120

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.

MED-IMAPS

Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy

• Primary Device ID: B214OSTBSI3120
• NIH Device Record Key: a4d97409-36a0-4cad-9f36-5391c0555bad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TBS iNsight
• Version Model Number: 3.1.2
• Company DUNS: 289058302
• Company Name: MED-IMAPS
• 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: false
• Serial Number: true
• 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: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com
• Phone: +1-608-669-9113
• Email: support@medimapsgroup.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B214OSTBSI3110 [Previous]
HIBCC	B214OSTBSI3120 [Primary]

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: 2022-01-21
• Device Publish Date: 2022-01-13

On-Brand Devices [TBS iNsight]

• B214OSTBSI303: TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical exa
• B214OSTBSI0: TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical exa
• B214OSTBSI3100: TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical exa
• B214OSTBSI3110: TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical exa
• B214OSTBSI3120: TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical exa