i-Rapha Solution

GUDID 08800184000023

IRM Inc

Medical equipment clinical data interfacing software

• Primary Device ID: 08800184000023
• NIH Device Record Key: d051a393-f4ba-4ba3-8e20-a3161d1ab90a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Rapha Solution
• Version Model Number: i-Rapha Solution
• Company DUNS: 689701122
• Company Name: IRM Inc
• Device Count: 1
• DM Exempt: true
• 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

Customer Support Contacts

• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr
• Phone: +827082306690
• Email: yikim@irm.kr

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800184000023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201296

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: 2025-02-26
• Device Publish Date: 2025-02-18