Imbio SET

Primary DI
00850894007209
Brand
Imbio SET
Company
Imbio, LLC
Model
1.0.3.2
Device description
Imbio Segmentation Editing Tool (SET) Software is a segmentation tool designedto allow users to optimize segmentations calculated by Imbio’s fully-automatedsuite of algorithms. Imbio is building a suite of medical image post-processing applicationsthat run automatically after data transfer off the medical imaging scanner.Automatic image segmentation is often an essential step in Imbio’s analyses.To date, the automatic segmentation algorithms used in Imbio’s applications havebeen robust, however segmentation failures do occur. The purpose of the SegmentationEditing Tool is to provide customers with a tool to locally correct poorsegmentations. Additionally, if the Imbio automatic segmentation fails such thatit is unable to produce a result, this tool can be used to semi-manually draw thesegmentation required for analysis.SET reads in anatomical images used in an automatic segmentation algorithmand the results of the automated segmentation algorithm (if available). The useris then able to locally correct insufficiencies in the segmentation result, or createa segmentation mask from scratch. The finalized segmentation mask is thenpushed back to Imbio’s Core Computing Platform and the job is re-processed.
Published
2018-06-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K180129000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180129000Imbio Segmentation Editing Tool softwareImbio, LLC2018-03-16LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850894007209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850894007209008508940072098508940072090850894007209

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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