1717WCE

GUDID 08800018602218

Solid state x-ray imager (flat panel/digital imager)

Rayence Co., Ltd.

Indirect flat panel x-ray detector

• Primary Device ID: 08800018602218
• NIH Device Record Key: 99393cd5-e1cb-4043-9b89-0ff1bc45a824
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1717WCE
• Version Model Number: 1717WCE
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800018602218 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242394

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-27
• Device Publish Date: 2024-09-19

Devices Manufactured by Rayence Co., Ltd.

• 08800018602256 - 2430TCA: 2025-04-16 Full-Field Digital Mammography System
• 08800018602218 - 1717WCE: 2024-09-27Solid state x-ray imager (flat panel/digital imager)
• 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.