1012WCC

GUDID 08800018600498

1012WCC 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: 08800018600498
• NIH Device Record Key: da5b0baa-7621-4fc2-957e-997f21261c56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1012WCC
• Version Model Number: 1012WCC
• 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	08800018600498 [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: 2016-11-11

Devices Manufactured by Rayence Co., Ltd.

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• 08800018602201 - 0909FCC-HS: 2024-03-29 X-ray, Fluoroscopic, image-intensified system
• 08800018602140 - 1417WCE: 2023-07-07 X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
• 08800018602157 - 1417WCE-HR: 2023-07-07 X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
• 08800018602164 - 1417WCE-HS: 2023-07-07 X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
• 08800018602171 - 1417WCE-GF: 2023-07-07 X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
• 08800018600924 - Vatech Clismile: 2022-06-08 This product is a orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocc
• 08800018600931 - Vatech Clismile: 2022-06-08 This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat maloc