RAYSCAN α+

GUDID 08800003001095

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: 08800003001095
• NIH Device Record Key: fe070c1a-cb1c-4268-9d08-8084931fd6af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAYSCAN α+
• Version Model Number: RCT700 - CT
• 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	08800003001095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160525

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: 4
• Public Version Date: 2023-04-12
• Device Publish Date: 2016-10-05

On-Brand Devices [RAYSCAN α+]

• 08800003001002: RCT700
• 08800003001347: RCT700-OCS +ENT
• 08800003001330: RCT700-OCL + ENT
• 08800003001323: RCT700-SC+ENT
• 08800003001316: RCT700-CT, Pano + ENT
• 08800003001446: CT,Pano(Jupi0606X) + One shot Ceph(FXDD-1012CA) +
• 08800003001439: CT,Pano(Jupi0606X) + One shot Ceph(FXRD-1717VA) +
• 08800003001422: CT,Pano(Jupi0606X) + Scan Ceph(XID) + ENT
• 08800003001415: CT,Pano(Jupi0606X) + ENT
• 08800003001408: CT,Pano(Jupi0606X) + One shot Ceph(FXDD-1012CA)
• 08800003001392: CT,Pano(Jupi0606X) + One shot Ceph(FXRD-1717VA)
• 08800003001385: CT,Pano(Jupi0606X) + Scan Ceph(XID)
• 08800003001378: CT,Pano(Jupi0606X)
• 08800003001361: CT,Pano(FXDD-0606CA) + One shot Ceph(FXDD-1012CA)
• 08800003001279: RCT700 - One shot Ceph(S)
• 08800003001262: RCT700 - One shot Ceph(L)
• 08800003001255: RCT700 - One shot Ceph(L)
• 08800003001248: RCT700 - Scan Ceph
• 08800003001231: RCT700 - CT,Pano
• 08800003001224: RCT700 - One shot Ceph(S)
• 08800003001217: RCT700 - One shot Ceph(L)
• 08800003001200: RCT700 - One shot Ceph(L)
• 08800003001194: RCT700-Scan Ceph
• 08800003001170: RCT700-One shot Ceph(L)
• 08800003001163: RCT700 - One shot Ceph(S)
• 08800003001156: RCT700 - One shot Ceph(L)
• 08800003001149: RCT700 - Scan Ceph
• 08800003001132: RCT700 - CT,Pano
• 08800003001125: RCT700 - One shot Ceph(S)
• 08800003001118: RCT700 - One shot Ceph(L)
• 08800003001101: RCT700 - Scan Ceph
• 08800003001095: RCT700 - CT
• 08800003001088: RCT700 - One shot Ceph(S) (XID)
• 08800003001071: RCT700 - One shot Ceph(S) (C10500D)
• 08800003001064: RCT700 - One shot Ceph(L) (XID)
• 08800003001057: RCT700 - One shot Ceph(L) (C10500D)
• 08800003001040: RCT700 - Scan Ceph (XID)
• 08800003001033: RCT700 - Scan Ceph (C10500D)
• 08800003001026: RCT700 - CT, Pano (XID)
• 08800003001019: RCT700 - CT, Pano (C10500D)