RapidiaColon System

GUDID 08809278790024

INFINITT Healthcare Co.,Ltd.

Radiology PACS software

• Primary Device ID: 08809278790024
• NIH Device Record Key: 3a56c03e-a740-493e-9ca4-49b38164e89e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RapidiaColon System
• Version Model Number: RapidiaColon System
• Company DUNS: 688319156
• Company Name: INFINITT Healthcare Co.,Ltd.
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809278790024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041761

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2023-06-19
• Device Publish Date: 2023-06-09

Devices Manufactured by INFINITT Healthcare Co.,Ltd.

• 08809278790000 - STARPACS: 2023-10-18
• 08809278790062 - INFINITT Cardiology PACS: 2023-10-18
• 08809278790079 - Xelis: 2023-10-18
• 08809278790086 - Xelis 3D: 2023-10-18
• 08809278790093 - Xelis Fusion: 2023-10-18
• 08809278790109 - Xelis Cardiac: 2023-10-18
• 08809278790116 - Xelis Dental: 2023-10-18
• 08809278790123 - INFINITT ULite: 2023-10-18