RIOScan

GUDID 08800003003327

Ray Co., Ltd

Dental computed radiography digital imaging scanner

• Primary Device ID: 08800003003327
• NIH Device Record Key: d38bb1f3-a0cd-4ec3-b8a0-a229b2b01787
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIOScan
• Version Model Number: IP Size 1
• 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	08800003003327 [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)