0909FCC-HS

GUDID 08800018602201

X-ray, Fluoroscopic, image-intensified system

Rayence Co., Ltd.

Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector

• Primary Device ID: 08800018602201
• NIH Device Record Key: 6378a842-0fd5-4350-ab3c-66ef1a8b75a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 0909FCC-HS
• Version Model Number: 0909FCC-HS
• 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	08800018602201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240371

FDA Product Code

• JAA: System, X-Ray, Fluoroscopic, Image-Intensified

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: 2024-03-29
• Device Publish Date: 2024-03-21

Devices Manufactured by Rayence Co., Ltd.

• 08800018602195 - 0909FCC: 2024-03-29 X-ray, Fluoroscopic, image-intensified system
• 08800018602201 - 0909FCC-HS: 2024-03-29X-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.
• 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