Imbio RV/LV

GUDID 00850894007643

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.

Imbio, LLC

X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software
Primary Device ID00850894007643
NIH Device Record Keya7501dda-0714-44d3-8e94-c1f45840d1c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameImbio RV/LV
Version Model Number3.0.0
Company DUNS078397649
Company NameImbio, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850894007643 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QIHAutomated Radiological Image Processing Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-17
Device Publish Date2021-12-09

On-Brand Devices [Imbio RV/LV]

00850894007605The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that t
00850894007636The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that t
00850894007643The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that t
00850894007728The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that t
00850894007766The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that t

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