FDA.reportPublic FDA data

Phantom

Primary DI
B214OSPTMV30
Brand
Phantom
Company
medimaps group SA
Model
3
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KGIDensitometer, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGIDensitometer, BoneRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B214OSPTMV30PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone densitometry ultrasound phantom, test objectA device that consists 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 and is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of ultrasound bone density measurement systems (bone densitometers) and associated image acquisition, display, and analysis computer programs.

Regulatory Flags#

DUNS number
486330728
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B214OSTBSIV400TBS iNsight4.02025-02-13
B214OSTBSI30TBS iNsight3.0.2.02017-02-07
B214OSPTM3Phantom32022-12-08
B214OSTBSI3120TBS iNsight3.1.22022-01-13
B214OSTBSI3110TBS iNsight3.1.12020-06-25
B214OSTBSI3100TBS iNsight3.1.02020-02-28
B214OSTBSI0Medimaps TBS iNsight3.0.1.02016-07-12
B214OSTBSI303TBS iNsight3.0.3.02018-08-30

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
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