FDA.reportPublic FDA data

IB Rad Tech

Primary DI
B319IBRADTECH20
Brand
IB Rad Tech
Company
IMAGING BIOMETRICS, LLC
Model
2.0
Published
2017-11-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123302000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123302000IB CLINICImaging Biometrics, LLC2013-01-11LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B319IBRADTECH20PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/ disc burning) and/or image manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
792265121
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B319IBFTBX20IB FTB Express2.02026-04-22
B319QSM1QSMetric12026-04-22
B319LSN1LSN12026-04-14
B319SC11StoneChecker1.12026-04-14
B319IBCLINIC120IB Clinic1.22016-09-23
B319IBCLINIC20IB Clinic2.02017-11-20
B319IBDCE120IB DCE1.22016-09-23
B319IBDCE20IB DCE2.02017-11-20
B319IBDELTASUITE120IB Delta Suite1.22016-09-23
B319IBDELTASUITE20IB Delta Suite2.02017-11-20
B319IBDIFFUSION12IB Diffusion1.22016-09-23
B319IBDIFFUSION20IB Diffusion2.02017-11-20
B319IBNEURO120IB Neuro1.22016-09-23
B319IBNEURO20IB Neuro2.02017-11-20
B319IBRADTECH120IB Rad Tech1.22016-09-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00817886020493JointsMEDSTRAT, INC.LLZ2023-03-06
00195278517340ViewPointGE Healthcare GmbHLLZ2023-02-15
00817886020486JointsMEDSTRAT, INC.LLZ2023-01-20
00670082000511Modus PlanSynaptive Medical IncLLZ2022-12-13
00817886020479JointsMEDSTRAT, INC.LLZ2022-10-29
00817886020462JointsMEDSTRAT, INC.LLZ2022-09-05
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