FEops

GUDID 05430002070032

FEops HEARTguide™ is indicated for patient-specific simulation of transcatheter left atrial appendage occlusion (LAAO) device implantation during procedural planning. The software performs computer simulation to predict implant frame deformation to support the evaluation for LAAO device size and placement. FEops HEARTguide™ is intended to be used by qualified clinicians in conjunction with the simulated device instructions for use, the patient’s clinical history, symptoms, and other preprocedural evaluations, as well as the clinician’s professional judgment. FEops HEARTguide™ is not intended to replace the simulated device instructions for use for final LAAO device selection and placement. FEops HEARTguide™ is prescription use only.

FEops

Radiology DICOM image processing application software

• Primary Device ID: 05430002070032
• NIH Device Record Key: 4b6900b3-0df6-4596-81f1-0e974dc2a677
• Commercial Distribution Discontinuation: 2021-11-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: FEops
• Version Model Number: 1.4.1
• Company DUNS: 400455685
• Company Name: FEops
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05430002070032 [Primary]

FDA Product Code

• QQI: Interventional Cardiovascular Implant Simulation Software Device

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: 2021-12-08
• Device Publish Date: 2021-11-30

On-Brand Devices [FEops]

• 05430002070032: FEops HEARTguide™ is indicated for patient-specific simulation of transcatheter left atrial ap
• 05430002070070: FEops HEARTguide™ is indicated for patient-specific simulation of transcatheter left atrial ap
• 05430002070063: FEops HEARTguide ALPACA 3.0.1
• 05430002070056: FEops HEARTguide Simulation Application
• 05430002070094: Feops HEARTguide Simulation Application
• 05430002070087: FEops HEARTguide ALPACA