RapidiaColon System

GUDID 08809278790024

INFINITT Healthcare Co.,Ltd.

Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological 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