RAYPreMiere

GUDID 08800003004317

Ray Co., Ltd

Stationary panoramic/tomographic dental x-ray system, digital

• Primary Device ID: 08800003004317
• NIH Device Record Key: 16c13d66-4089-41b5-8b26-1e9a33bbe786
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAYPreMiere
• Version Model Number: RCT800-CT,Pano(FXDD-1012CHA) + One shot Ceph(FXRD-
• 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	08800003004317 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230753

FDA Product Code

• OAS: X-Ray, Tomography, Computed, Dental

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: 2023-04-25
• Device Publish Date: 2023-04-17

On-Brand Devices [RAYPreMiere]

• 08800003004324: RCT800-CT,Pano(FXDD-1012CHA) + One shot Ceph(FXDD-
• 08800003004317: RCT800-CT,Pano(FXDD-1012CHA) + One shot Ceph(FXRD-
• 08800003004300: RCT800-CT,Pano(FXDD-1724RA) + One shot Ceph(FXDD-1
• 08800003004294: RCT800-CT,Pano(FXDD-1724RA) + One shot Ceph(FXRD-1
• 08800003004287: RCT800-CT,Pano(FXDD-1724RA) + Scan Ceph(XID-C24DC)
• 08800003004270: RCT800-CT,Pano(FXDD-1724RA)