Imbio RV/LV

GUDID 00850894007766

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

• Primary Device ID: 00850894007766
• NIH Device Record Key: 8ca409ec-ade1-44fa-90dd-8f802b4579fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Imbio RV/LV
• Version Model Number: 3.1.1
• Company DUNS: 078397649
• Company Name: Imbio, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850894007766 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203256

FDA Product Code

• QIH: Automated Radiological Image Processing Software

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-08
• Device Publish Date: 2023-04-28

On-Brand Devices [Imbio RV/LV]

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