Imbio CAC

Primary DI
00850894007797
Brand
Imbio CAC
Company
Imbio, LLC
Model
2.0.0
Device description
Imbio’s Coronary Artery Calcification (CAC) software is a set of automated image post-processing algorithms designed to help radiologists and cardiologists determine the location and calculate the amount of calcification within the coronary arteries in patients who have undergone a non- contrast, chest computed tomography (CT), by providing visualization and quantification of abnormal coronary CT densities. The Imbio CAC software runs automatically on the input CT series, with no user input or intervention.The Imbio CAC software analyses high resolution CT DICOM images of the heart. The Imbio CAC algorithm provides a DICOM or PDF summary report with the results of the analysis.
Published
2023-07-19
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
K230112000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230112000CAC SoftwareImbio, Inc.2023-06-13JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850894007797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850894007797008508940077978508940077970850894007797

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
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
00850894007582Imbio LDA3.0.32021-01-27

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