FDA.reportPublic FDA data

Model 4 CT Calibration Phantom

Primary DI
B052PHCTM40
Brand
Model 4 CT Calibration Phantom
Company
MINDWAYS SOFTWARE, INC.
Model
4
Device description
Calibration phantom intended for use as an accessory to the QCT Pro Bone Mineral Densitometry Software.
Published
2023-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
B052PHCTM40PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone densitometry x-ray phantom, test objectA device that consist of a uniform density or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions. It includes phantoms that come in both fixed and variable configurations. It is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of x-ray based bone density measurement systems and associated image acquisition, display, and analysis computer programs.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
964202592
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
B052QCTPROM4ASH0QCT PRO Asynchronous 3D Spine and CTXA-Hip SystemK894854K002113K030330K140342QCTPROM4ASH2017-03-31

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
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
B052DICTXAHIPEXTDB0CTXA Hip Extended Reference DataMINDWAYS SOFTWARE, INC.KGI2017-03-31