RAYSCAN Studio

GUDID 08800003004201

Ray Co., Ltd

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• Primary Device ID: 08800003004201
• NIH Device Record Key: ff75e66d-8f3f-41fd-b89d-0f50558a4238
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAYSCAN Studio
• Version Model Number: RCT800-CT,Pano+OCS+LED
• 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	08800003004201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192737

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: 2019-11-26

On-Brand Devices [RAYSCAN Studio]

• 08800003004003: RCT800
• 08800003004201: RCT800-CT,Pano+OCS+LED
• 08800003004195: RCT800-CT,Pano+OCL+LED
• 08800003004188: RCT800-CT,Pano+ScanCeph+LED
• 08800003004171: RCT800-CT,Pano+LED
• 08800003004164: RCT800-CT,Pano(L)+OCS+M
• 08800003004157: RCT800-CT,Pano(L)+OCL+M
• 08800003004140: RCT800-CT,Pano(L)+ScanCeph+M
• 08800003004133: RCT800-CT,Pano(L)+M
• 08800003004126: RCT800-CT,Pano(L)+OCS
• 08800003004119: RCT800-CT,Pano(L)+OCL
• 08800003004102: RCT800-CT,Pano(L)+ScanCeph
• 08800003004096: RCT800-CT,Pano(L)
• 08800003004089: RCT800-CT,Pano+OCS+M
• 08800003004072: RCT800-CT,Pano+OCL+M
• 08800003004065: RCT800-CT,Pano+ScanCeph+M
• 08800003004058: RCT800-CT,Pano+M
• 08800003004041: RCT800-CT,Pano+OCS
• 08800003004034: RCT800-CT,Pano+OCL
• 08800003004027: RCT800-CT,Pano+ScanCeph
• 08800003004010: RCT800-CT,Pano