RCT600

GUDID 08800003027064

Ray Co., Ltd

Stationary panoramic/tomographic dental x-ray system, digital

• Primary Device ID: 08800003027064
• NIH Device Record Key: e40304c2-07bd-492c-8011-323a441d7e7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RCT600
• Version Model Number: Configurable Device (CT, Pano + Option)
• 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	08800003027064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243903

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: 2025-04-22
• Device Publish Date: 2025-04-14

On-Brand Devices [RCT600]

• 08800003027071: Option (Scan Ceph)
• 08800003027064: Configurable Device (CT, Pano + Option)