Imbio LDA

Primary DI
00850894007551
Brand
Imbio LDA
Company
Imbio, LLC
Model
3.0.0
Device description
The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms that perform image segmentation, registration, thresholding, and classification on CT images of human lungs.Imbio CT Lung Density Analysis Software is a command-line software application that analyzes DICOM CT lung image datasets and generates reports and DICOM output that show the lungs segmented and overlaid with color-codings representing the results of its thresholding and classification rules. It has simple file management functions for input and output. Imbio CT Lung Density Analysis Software does not interface directly with any CT or data collection equipment; instead the software imports data files previously generated by such equipment.
Published
2020-08-05
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
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141069000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141069000Lung Density AnalysisImbio, LLC2014-09-17JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850894007551PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850894007551008508940075518508940075510850894007551

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
078397649
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850894007902Imbio PHA4.0.02025-04-21
00850894007926Imbio LDA5.1.12025-04-14
00850894007933Imbio LDA5.1.12025-02-11
00850894007889Imbio LDA5.1.02024-05-08
00850894007735Imbio Freya4.0.12023-01-24
00850894007865Imbio LDA5.0.32023-11-06
00850894007841Imbio LDA5.0.22023-10-17
00850894007858Imbio Freya5.0.22023-10-17
00850894007810Imbio LDA5.0.12023-09-18
00850894007827Imbio Freya5.0.12023-09-18
00850894007797Imbio CAC2.0.02023-07-19
00850894007773Imbio LDA5.0.02023-07-12
00850894007780Imbio Freya5.0.02023-07-12
00850894007759Imbio SET1.0.3.52023-06-07
00850894007674Imbio LDA4.1.02022-09-06
00850894007681Imbio Freya3.3.02022-04-25
00850894007667Imbio Freya3.2.02022-02-01
00850894007629Imbio LDA4.0.02021-09-10
00850894007612Imbio LDA3.1.12021-05-25
00850894007599Imbio LDA3.12021-03-29

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