RAYSCAN α-Expert3D

GUDID 08800003000159

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 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: 08800003000159
• NIH Device Record Key: e4c910e5-78cf-403c-81b5-2992c67a7bc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAYSCAN α-Expert3D
• Version Model Number: 3D-CT,Pano
• 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	08800003000159 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190812

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-04-12
• Device Publish Date: 2019-05-15

On-Brand Devices [RAYSCAN α-Expert3D]

• 08800003000197: M3DS-CT,Pano+One Shot Ceph(PaxScan 2530C)
• 08800003000180: M3DL-CT,Pano+One shot Ceph(1717SCC)
• 08800003000173: M3DL-CT,Pano+One shot Ceph(PaxScan 4336X)
• 08800003000166: SM3D-CT,Pano+Scan Ceph(XID)
• 08800003000159: 3D-CT,Pano
• 08800003000234: M3DS-CT,Pano(FXDD-0606CA)+FXDD-1012CA
• 08800003000227: M3DL-CT,Pano(FXDD-0606CA)+FXRD-1717VA
• 08800003000210: SM3D-CT,Pano(FXDD-0606CA)+Scan Ceph(XID-C24DC)
• 08800003000203: 3D-CT,Pano(FXDD-0606CA)