RAYSCAN a+

GUDID 08800003001354

Ray Co., Ltd

Stationary panoramic/tomographic dental x-ray system, digital

• Primary Device ID: 08800003001354
• NIH Device Record Key: 7d0ad5e6-5fb0-43e9-a7b9-3f46b053381c
• Commercial Distribution Discontinuation: 2023-02-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: RAYSCAN a+
• Version Model Number: CT,Pano(FXDD-0606CA) + One shot Ceph(FXRD-1717VA)
• 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	08800003001354 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213226

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: 2023-02-22
• Device Publish Date: 2023-02-14

Devices Manufactured by Ray Co., Ltd

• 08800003027026 - RCT700: 2025-12-09
• 08800003027002 - RCT700: 2025-09-02
• 08800003027019 - RCT700: 2025-09-02
• 08800003027033 - RCT700: 2025-09-02
• 08800003027040 - RCT700: 2025-09-02
• 08800003027057 - RCT800: 2025-09-02
• 08800003027088 - RAYSCAN α-P: 2025-09-02
• 08800003027095 - RAYSCAN α-3D: 2025-09-02