STAR Apollo STAR Apollo Mapping System

GUDID 00860009793507

The STAR Apollo Mapping System is a cardiac mapping method that is based on proprietary algorithms developed to identify localized sources of atrial activation during AF. The STAR Apollo Mapping System does not aim to elucidate the mechanism of AF, rather it seeks to reveal the anatomical location of regions where activation may be originating from, regardless of mechanism. This is based on a very simple and fundamental principle that the source of activation will have activation emerging from it in multiple directions, but not progressing towards it.

Rhythm AI Inc.

Cardiac mapping system application software

• Primary Device ID: 00860009793507
• NIH Device Record Key: 04706e21-0c04-4d2d-9511-dabfcebd3bb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STAR Apollo
• Version Model Number: STAR Apollo Mapping System
• Catalog Number: STAR Apollo Mapping System
• Company DUNS: 118967950
• Company Name: Rhythm AI Inc.
• 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: true
• 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

Customer Support Contacts

• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com
• Phone: 8583261655
• Email: info@rhythm-ai.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009793507 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220786

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

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: 2023-06-16
• Device Publish Date: 2023-06-08