I-Rapha View

GUDID 08800184000009

IRM Inc

Radiological PACS software

• Primary Device ID: 08800184000009
• NIH Device Record Key: be3fcebf-a3bd-46bd-a093-265a742e7e09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: I-Rapha View
• Version Model Number: I-Rapha View
• Company DUNS: 689701122
• Company Name: IRM Inc
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800184000009 [Primary]

FDA Product Code

• LMD: System, Digital Image Communications, 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: 2025-08-11
• Device Publish Date: 2025-08-01

Devices Manufactured by IRM Inc

• 08800184000009 - I-Rapha View: 2025-08-11
• 08800184000009 - I-Rapha View: 2025-08-11
• 08800184000023 - i-Rapha Solution: 2025-02-26