Digital Intraoral X-ray Imaging System /

GUDID 06970569090245

The Digital Intra-Oral X-Ray Imaging System (Pluto0001X/Pluto0002X) is used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination and the diagnosis of structural diseases. The product is expected to be used in hospitals and clinics, operated and used by trained professionals under the guidance of doctors. This device is not intended for mammography and conventional photography applications. This device is suitable for providing dental radiography imaging for both adult and pediatric.

iRay Technology Co. Ltd.

Dental digital imaging sensor, intraoral

• Primary Device ID: 06970569090245
• NIH Device Record Key: 8a04761d-9e0f-45b4-837e-a4ba820164bb
• Commercial Distribution Discontinuation: 2021-07-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digital Intraoral X-ray Imaging System
• Version Model Number: Pluto0002X
• Catalog Number: /
• Company DUNS: 421363780
• Company Name: iRay Technology 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970569090245 [Primary]

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: 2021-07-19
• Device Publish Date: 2021-07-09

On-Brand Devices [Digital Intraoral X-ray Imaging System]

• 06970569090252: The Digital Intra-Oral X-Ray Imaging System (Pluto0001X/Pluto0002X) is used in conjunction with
• 06970569090245: The Digital Intra-Oral X-Ray Imaging System (Pluto0001X/Pluto0002X) is used in conjunction with
• 06970569090597: The Digital Intra-Oral X-Ray Imaging System (Pluto0015X) is used in conjunction with dental Radi
• 06970569090580: The Digital Intra-Oral X-Ray Imaging System (Pluto0000X) is used in conjunction with dental Radi
• 06970569090924: The Digital Intra-Oral X-Ray Imaging System (Prime View Ultra 2) is used in conjunction with den
• 06970569090917: The Digital Intra-Oral X-Ray Imaging System (Prime View Ultra 1.5) is used in conjunction with d
• 06970569090900: The Digital Intra-Oral X-Ray Imaging System (Prime View Ultra 1) is used in conjunction with den
• 06970569090894: The Digital Intra-Oral X-Ray Imaging System (Prime View Ultra 0) is used in conjunction with den