Who else makes this device?

Name: TBS iNsight
Brand: TBS iNsight

Radiology › DiagnosticDensitometer, Bone

TBS Insight

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…

Registry build 21.09.26

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.

1manufacturer

6catalogue numbers in this listing

3510(k) clearances naming this product code

2recalls on this code

Who Else Makes It

Registered in Beijing.

Chinese manufacturers registered for FDA product code KGI
Manufacturer	City	Province	Registered as	Device types
GE Hangwei Medical Systems Co., Ltd.	Beijing	Beijing	Specification developer	22

Record

Regulatory record for TBS iNsight
Listed by	Medimaps Group SA, Switzerland
FDA product code	KGI
Device type	Densitometer, Bone
Device class	Class 2
Regulation	21 CFR 892.1170
Establishment	Manufacturer
510(k)	K243218
Record published	2020-06-25
Record revised	2023-10-04 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, serial number
Distribution end date	2020-04-17

Catalogue Numbers

Catalogue numbers for TBS iNsight
Catalogue number	Size	Status
3.1.1		In distribution
3.0.3.0		In distribution
3.0.2.0		In distribution
4.0		In distribution
3.1.2		In distribution
3.1.0		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Prodigy	GE Medical Systems Ultrasound & Primary Care Diagnostics LLC	4
3D-SHAPER	3D-SHAPER Medical S.L.	2
QCT PRO Asynchronous 3D Spine and CTXA-Hip System	Mindways Software, Inc.	2
Densitometer, Bone	Stratec Medizintechnik Gmbh	2
Horizon Ci	Hologic, Inc.	1
QCT Pro Asynchronous Calibration Module, CliniQCT	Mindways Software, Inc.	1
XR-600 Basic	Norland at Swissray	1
Discovery A	Hologic, Inc.	1
Medimaps TBS iNsight	Medimaps Group SA	1
Model 4 CT Calibration Phantom	Mindways Software, Inc.	1
Discovery SL	Hologic, Inc.	1
IlluminatusDXA Software	Norland at Swissray	1

Showing 12 of 38. All products under Densitometer, Bone

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K243218	2025-01-17
K152299	2016-04-29
K121716	2012-10-05

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of TBS iNsight
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Medimaps Group SA	UDI-DI	2025-02-03	Class II	Software Design Change	Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.	2036 units (724 US, 1312 OUS)

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2016-10-03	Class II	Under Investigation by firm	The FRAX adjusted for TBS values are not correct when: The FRAX feature is activated in TBS iNsight; and TBS has been computed from a spine scan where some vertebrae were excluded.	15 units in US	2017-06-07

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.