1012WCA

GUDID 08800018600283

1012WCA 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: 08800018600283
• NIH Device Record Key: 1dee9176-bddf-4cee-a332-1ce15da95b02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1012WCA
• Version Model Number: 1012WCA
• 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	08800018600283 [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: 2016-09-16

Devices Manufactured by Rayence Co., Ltd.

• 08800018602218 - 1717WCE: 2024-09-27 Solid state x-ray imager (flat panel/digital imager)
• 08800018602225 - 1717WCE-HR: 2024-09-27 Solid state x-ray imager(flat panel/digital imager)
• 08800018602232 - 1717WCE-HS: 2024-09-27 X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
• 08800018602249 - 1717WCE-GF: 2024-09-27 X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
• 08800018602195 - 0909FCC: 2024-03-29 X-ray, Fluoroscopic, image-intensified system
• 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.