1717SGC

GUDID 08800018600528

1717SGC is a digital X-ray flat panel detector that can acquire radiographic images of human anatomy when used with existing radiographic x-ray systems

Rayence Co., Ltd.

Indirect flat panel x-ray detector

• Primary Device ID: 08800018600528
• NIH Device Record Key: 0f635b9f-4aa4-4238-b6ef-8b73c425cc9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1717SGC
• Version Model Number: 1717SGC
• Company DUNS: 557804458
• Company Name: Rayence 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800018600528 [Primary]

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

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: 2019-05-07
• Device Publish Date: 2017-07-06

On-Brand Devices [1717SGC]

• 08800018600528: 1717SGC is a digital X-ray flat panel detector that can acquire radiographic images of human ana
• 08800018600245: 1717SGC is a digital x-ray flat panel detector that can generate images of any part of the body.