RIOScan

GUDID 08800003003358

Ray Co., Ltd

Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner

• Primary Device ID: 08800003003358
• NIH Device Record Key: 14b854dc-82ab-45bd-b9d1-c5ad7896040f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIOScan
• Version Model Number: IP Size 4
• Company DUNS: 690324087
• Company Name: Ray 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800003003358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160788

FDA Product Code

• MUH: System,X-Ray,Extraoral Source,Digital

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-10-05

On-Brand Devices [RIOScan]

• 08800003003372: OCC option
• 08800003003365: IP Size 1, 3
• 08800003003358: IP Size 4
• 08800003003341: IP Size 3
• 08800003003334: IP Size 2
• 08800003003327: IP Size 1
• 08800003003310: IP Size 0
• 08800003003020: RPS500 (OCC)
• 08800003003013: RPS500 (STD)