FDA.reportPublic FDA data

Imbio RV/LV

Primary DI
00850894007643
Brand
Imbio RV/LV
Company
Imbio, LLC
Model
3.0.0
Device description
The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that together perform automated image segmentation and diameter measurements on computed tomography pulmonary angiography (CTPA) images. The device then reports the ratio of those diameter measurements. The Imbio CT RV/LV Software is a single command-line executable program that may be run directly from the command-line or through scripting and thus the user interface is minimal.
Published
2021-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203256000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203256000Imbio RV/LV SoftwareImbio, LLC2021-03-09QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850894007643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850894007643008508940076438508940076430850894007643

GMDN Terms#

Term, Definition table
TermDefinition
X-ray image interpretive softwareAn interpretive software program intended to be used to analyse non-dental x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].

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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