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TBS iNsight

FDA UDI

Class II (US FDA UDI)

by medimaps group SA

Identity

Trade Name
TBS iNsight FDA UDI
Generic Name
Basic diagnostic x-ray system application software FDA UDI
Device Name
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. FDA UDI
Model / Reference
4.0 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
B214OSTBSIV400 FDA UDI
510(k) Number
K243218 FDA UDI
FDA Product Code
KGI FDA UDI
GMDN Term
Basic diagnostic x-ray system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1170 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Basic diagnostic x-ray system application software

TBS iNsight by medimaps group SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Basic diagnostic x-ray system application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
medimaps group SA

Sources (1)

  • FDA UDI 4b2e02ef-c369-4529-9ac9-3b8719fc51ad 35 fields · synced Jun 6, 2026