1417WCE-HS

Basic Information

• Brand Name: 1417WCE-HS
• Primary DI: 08800018602164
• Version / Model: 1417WCE-HS
• Company Name: Rayence Co., Ltd.
• Labeler DUNS: 557804458
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-29
• Public Version: 1
• Public Version Date: 2023-07-07
• Public Version Status: New
• Public Device Record Key: a3dd3fea-1f89-45d5-a54c-9ed6b1fbf6d2

Device Description

X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	892.1680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61108	Indirect flat panel x-ray detector	An electrically-powered, cassette-like device intended to be used as part of an x-ray system to detect x-ray images following exposure, and create a digital signal; it is not dedicated to imaging of a specific anatomy. It includes two types of transducing technology (i.e., indirect): a scintillator [e.g. caesium iodide (CsI)] screen converts x-ray energy into light, followed by the conversion of light into a digital signal by photodiode array. The image data can be sent to an appropriate processing unit through a wired or wireless connection (e.g., Wi-Fi). It may be used in place of a fixed detector in x-ray imaging systems, e.g., as part of a digital imaging conversion system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800018602164	GS1

Premarket Submissions

Submission Number	Supplement Number
K231467	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 50 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 5 – 35 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal