FEops

GUDID 05430002070063

FEops HEARTguide ALPACA 3.0.1

FEops

Radiology DICOM image processing application software

• Primary Device ID: 05430002070063
• NIH Device Record Key: a57d36e9-13fb-4c75-bbd9-a3eac37444b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FEops
• Version Model Number: 3.0.1
• Company DUNS: 400455685
• Company Name: FEops
• 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	05430002070063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223855

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: 2023-07-10
• Device Publish Date: 2023-06-30

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