TBS iNsight - TBS iNsight is a software provided for use as a - MED-IMAPS

Duns Number:289058302

Device Description: TBS iNsight is a software provided for use as a complement to both DXA analysis and clinic 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.

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More Product Details

Catalog Number

-

Brand Name

TBS iNsight

Version/Model Number

3.1.0

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 17, 2020

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KGI

Product Code Name

Densitometer, Bone

Device Record Status

Public Device Record Key

faa9eed4-a0a1-4472-bc46-d44609ef40ce

Public Version Date

July 23, 2021

Public Version Number

2

DI Record Publish Date

February 28, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MED-IMAPS" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6