FDA.reportPublic FDA data

QCT PRO Asynchronous 3D Spine and CTXA-Hip System

Primary DI
B052QCTPROM4ASH0
Brand
QCT PRO Asynchronous 3D Spine and CTXA-Hip System
Company
MINDWAYS SOFTWARE, INC.
Model
K894854K002113K030330K140342
Catalog number
QCTPROM4ASH
Device description
Convenience Kit consisting of- QCT Pro Asynchronous Calibration Module, CliniQCT- QCT Bone Mineral Density Analysis Software- CTXA Hip Bone Mineral Densitometer- CTXA Hip Extended Reference Database- Model 4 Calibration Phantom
Published
2017-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGIDensitometer, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGIDensitometer, BoneRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002113000
K030330000
K140342000
K894854000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002113000CTXA HIP; CTXA; QCT PRO CTXA HIPMindways Software, Inc.2001-12-04KGI
K030330000CTXA HIP EXTENDED REFERENCE DATAMindways Software, Inc.2003-06-20KGI
K140342000QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCTMindways Software, Inc.2014-08-29KGI
K894854000QCT BONE MINERAL DENSITY ANALYSIS SOFTWAREImage Enhancements1989-10-19KGI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
QCTPROM4ASHN0002PackageHIBCC2In Commercial Distribution
QCTPROM4ASHN0003PackageHIBCC3In Commercial Distribution
QCTPROM4ASHN0005PackageHIBCC5In Commercial Distribution
QCTPROM4ASHN0010PackageHIBCC10In Commercial Distribution
QCTPROM4ASHN0025PackageHIBCC25In Commercial Distribution
QCTPROM4ASHN0050PackageHIBCC50In Commercial Distribution
QCTPROM4ASHN0075PackageHIBCC75In Commercial Distribution
QCTPROM4ASHN0100PackageHIBCC100In Commercial Distribution
QCTPROM4ASHN0200PackageHIBCC200In Commercial Distribution
QCTPROM4ASHN0500PackageHIBCC500In Commercial Distribution
B052QCTPROM4ASH0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
CT system application softwareAn application software program intended to add specific image processing and/or analysis capabilities to an x-ray computed tomography (CT) imaging system; it is not dedicated to radiotherapy treatment planning. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routines must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and version or upgrade number.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 512 912-0871info@qct.com

Regulatory Flags#

DUNS number
964202592
Device count
1
Kit
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B052PHCTM40Model 4 CT Calibration Phantom42023-05-04
B052DIASYNC0QCT Pro Asynchronous Calibration Module, CliniQCTK140342DI_ASYNC2017-03-31
B052DICTXAHIP0CTXA Hip Bone Mineral DensitometerK002113DI_CTXAHIP2017-03-31
B052DICTXAHIPEXTDB0CTXA Hip Extended Reference DataK030330DI_CTXAHIPEXTDB2017-03-31
B052DIQCTPRO0QCT Bone Mineral Density Analysis SoftwareK894854DI_QCTPRO2017-03-31
B052QCTPROM0AS0QCT PRO Asynchronous 3D Spine SoftwareK894854K140342QCTPROM0AS2017-03-31
B052QCTPROM0ASH0QCT PRO Asynchronous 3D Spine and CTXA-Hip SoftwareK894854K002113K030330K140342QCTPROM0ASH2017-03-31
B052QCTPROM0SS0QCT PRO 3D Volumetric Spine SoftwareK894854QCTPROM0SS2017-03-31
B052QCTPROM0SSH0QCT PRO 3D Volumetric Spine and CTXA Hip SoftwareK894854K002113K030330QCTPROM0SSH2017-03-31
B052QCTPROM3ASH0QCT PRO Asynchronous 3D Spine and CTXA-Hip SystemK894854K002113K030330K140342QCTPROM3ASH2017-03-31
B052QCTPROM3SS0QCT PRO 3D Volumetric Spine SystemK894854QCTPROM3SS2017-03-31
B052QCTPROM3SSH0QCT PRO 3D Volumetric Spine and CTXA Hip SystemK894854K002113K030330QCTPROM3SSH2017-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
084370217400663D-SHAPER3D-SHAPER MEDICAL S.L.KGI2026-05-12
B214OSTBSIV400TBS iNsightmedimaps group SAKGI2025-02-13
084370217400283D-SHAPER3D-SHAPER MEDICAL S.L.KGI2023-10-04
B052PHCTM40Model 4 CT Calibration PhantomMINDWAYS SOFTWARE, INC.KGI2023-05-04
B214OSPTMV30Phantommedimaps group SAKGI2022-12-08
B214OSPTM3Phantommedimaps group SAKGI2022-12-08
B214OSTBSI3120TBS iNsightmedimaps group SAKGI2022-01-13
00866955000478IlluminatusDXA SoftwareNorland at SwissrayKGI2020-07-27
B214OSTBSI3110TBS iNsightmedimaps group SAKGI2020-06-25
B214OSTBSI3100TBS iNsightmedimaps group SAKGI2020-02-28
B214OSTBSI303TBS iNsightmedimaps group SAKGI2018-08-30
00860000233101VirtuOstO N DIAGNOSTICS LLCKGI2018-08-15
00840682138345ProdigyGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCKGI2018-07-03
00840682138352ProdigyGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCKGI2018-07-03
15420045507494APEX Practice Managment ToolHologic, Inc.KGI2018-04-04
00866955000409XR-600 Basic Norland at SwissrayKGI2017-11-16
00866955000416XR-600 Clinical Norland at SwissrayKGI2017-11-16
00866955000423XR-600 AdvancedNorland at SwissrayKGI2017-11-16
00866955000430XR-800 BasicNorland at SwissrayKGI2017-11-16
00866955000447XR- 800 ClinicalNorland at SwissrayKGI2017-11-16
00866955000454XR-800 AdvancedNorland at SwissrayKGI2017-11-16
00866955000461EliteNorland at SwissrayKGI2017-11-16
15420045506893Discovery SLHologic, Inc.KGI2017-11-15
15420045506909Discovey CHologic, Inc.KGI2017-11-15
15420045506916Discovery WHologic, Inc.KGI2017-11-15
15420045506879Discovery AHologic, Inc.KGI2017-09-22
04260491560018NAStratec Medizintechnik GmbHKGI2017-04-26
04260491560025NAStratec Medizintechnik GmbHKGI2017-04-26
B052DIASYNC0QCT Pro Asynchronous Calibration Module, CliniQCTMINDWAYS SOFTWARE, INC.KGI2017-03-31
B052DICTXAHIP0CTXA Hip Bone Mineral DensitometerMINDWAYS SOFTWARE, INC.KGI2017-03-31