RAYSCAN α-Expert

GUDID 08800003000272

Ray Co., Ltd

Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital

• Primary Device ID: 08800003000272
• NIH Device Record Key: 640ee657-bed4-4137-8942-03d786fba1bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAYSCAN α-Expert
• Version Model Number: SC-Pano(Pluto0600X)+Scan Ceph(XID-C24DC)
• 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	08800003000272 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232325

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-06
• Device Publish Date: 2024-04-26

On-Brand Devices [RAYSCAN α-Expert]

• 08800003000319: SC-Pano(C10500D)+Scan Ceph(XID-C24DC)
• 08800003000302: Pano(C10500D)
• 08800003000296: OCL-Pano(Pluto600X)+FXRD-1717VA
• 08800003000289: OCS-Pano(Pluto0600X)+FXDD-1012CA
• 08800003000272: SC-Pano(Pluto0600X)+Scan Ceph(XID-C24DC)
• 08800003000265: Pano(Pluto0600X)
• 08800003000258: OCL-Pano(C10500D)+FXRD-1717VA
• 08800003000241: OCS-Pano(C10500D)+FXDD-1012CA