Digital Intraoral X-Ray Sensor /

GUDID 06970569090559

The CS 6200 is a USB-driven digital intraoral X-ray sensor based on CMOS technology that is specially designed for acquiring real-time high-quality dental diagnostic images. Image data acquired from the device can be transmitted via a USB 2.0 port to a workstation for display and processing.

iRay Technology Co. Ltd.

Dental digital imaging sensor, intraoral

• Primary Device ID: 06970569090559
• NIH Device Record Key: d663d538-6c34-4434-8fb1-f6ef48dbcbc8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digital Intraoral X-Ray Sensor
• Version Model Number: CS 6200
• 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	06970569090559 [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: 2023-05-04
• Device Publish Date: 2023-04-26

Devices Manufactured by iRay Technology Co. Ltd.

• 06970569090894 - Digital Intraoral X-ray Imaging System: 2024-11-04 The Digital Intra-Oral X-Ray Imaging System (Prime View Ultra 0) is used in conjunction with dental Radiography in medical units
• 06970569090900 - Digital Intraoral X-ray Imaging System: 2024-11-04 The Digital Intra-Oral X-Ray Imaging System (Prime View Ultra 1) is used in conjunction with dental Radiography in medical units
• 06970569090917 - Digital Intraoral X-ray Imaging System: 2024-11-04 The Digital Intra-Oral X-Ray Imaging System (Prime View Ultra 1.5) is used in conjunction with dental Radiography in medical uni
• 06970569090924 - Digital Intraoral X-ray Imaging System: 2024-11-04 The Digital Intra-Oral X-Ray Imaging System (Prime View Ultra 2) is used in conjunction with dental Radiography in medical units
• 06970569090610 - Wireless Digital Flat Panel Detector: 2024-10-25 Luna1012X (configuration: Luna1012X-G) Wireless Digital Flat Panel Detector
• 06970569090870 - Wireless Digital Flat Panel Detector(19 pin): 2024-10-24 Mars1717X(19 pin) wireless digital flat panel detector is indicated for digital imaging solutions designed to provide general r
• 06970569090887 - Wireless Digital Flat Panel Detector(19 pin): 2024-10-24 Mars1417X(19 pin) wireless digital flat panel detector is indicated for digital imaging solutions designed to provide general ra
• 06970569090566 - Wireless Digital Flat Panel Detector: 2024-03-08 Mars1417X(Configuration:Mars1417X-PI) wireless digital flat panel detector is indicated for digital imaging solutions designed t