Who else makes this device?

Name: QCT PRO 3D Volumetric Spine and Ctxa Hip System
Brand: QCT PRO 3D Volumetric Spine and Ctxa Hip System

Radiology › DiagnosticDensitometer, Bone

QCT PRO 3d Volumetric Spine and Ctxa Hip System

Convenience Kit consisting of - QCT Bone Mineral Density Analysis Software - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended Reference Database - Model 3 QA & Calibration Phantom Set

Registry build 21.09.26

1manufacturer

1catalogue number

3510(k) clearances naming this product 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 QCT PRO 3D Volumetric Spine and Ctxa Hip System
Listed by	Mindways Software, Inc., United States
FDA product code	KGI
Device type	Densitometer, Bone
Device class	Class 2
Regulation	21 CFR 892.1170
Establishment	Manufacturer
510(k)	K002113
Record published	2017-03-31
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, serial number
Storage	Handling environment temperature -40 to 60 °C

Catalogue Numbers

Catalogue numbers for QCT PRO 3D Volumetric Spine and Ctxa Hip System
Catalogue number	Size	Status
K894854K002113K030330		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
TBS iNsight	Medimaps Group SA	6
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

Showing 12 of 38. All products under Densitometer, Bone

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K140342	2014-08-29
K030330	2003-06-20
K002113	2001-12-04

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.