WeRay

GUDID 18809840720043

WERAY is a battery-operated, portable dental X-ray source designed for handheld operation. It is intended to produce diagnostic-quality X-ray images. The WERAY is designed for use in a dental office. It can also be used in other similar environments (orthodontic office, general practitioner’s office, hospital ward, etc.) where appropriate safeguards are implemented. The device uses a rechargeable battery to allow the WERAY to be used. Still, transportation or using other X-ray devices might be prohibitive due to the other devices’ size and/or lack of mobility. The WERAY is an X-ray device with an AC/DC adaptor. The handheld device features a main body (tube head), a Cone for the sensor, Acryl shielding, a cradle, a Hand switch for X-ray exposure, and an AC/DC adaptor. The power is supplied by a rechargeable Lithium-ion polymer battery pack built into a main body. This facilitates the portability of the device. A beam-limiting cone is incorporated within the device. The acryl shielding provides sufficient radiation protection to allow the clinician to remain in the operatory with the patient. A hand switch is available to expose X-rays in a location away from the device. WERAY uses a fixed tube voltage of 70kV and a fixed tube current of 2.0 mA to make the system as simple as possible for the operator. The only operator-adjustable parameter is the exposure time. This adjustment can be quickly accomplished through the user-friendly control panel. Control buttons, a display panel, and an exposure button provide the primary operator interface. Exposure settings can be selected and displayed. The tube voltage (70 kV) and tube current (2.0 mA) are fixed, with the exposure time varying based on patient type, detector type, and anatomical features. Exposures can be completed using the exposure button. The WERAY should be used with an X-ray detector and a digital intraoral sensor. But the X-ray detector is not included in the device package.

PICOPACK Inc.

Hand-held intraoral dental x-ray system, digital

• Primary Device ID: 18809840720043
• NIH Device Record Key: b5e30314-4d30-4615-bc11-c61295666f3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WeRay
• Version Model Number: P70A
• Company DUNS: 694616916
• Company Name: PICOPACK Inc.
• 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

Customer Support Contacts

• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr
• Phone: +82423625056
• Email: cs@picopack.co.kr

Device Dimensions

• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter
• Depth: 106 Millimeter
• Height: 269 Millimeter
• Width: 302 Millimeter

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809840720046 [Primary]
GS1	18809840720043 [Package]; Contains: 08809840720046; Package: Cardboard [5 Units]; In Commercial Distribution
GS1	28809840720040 [Package]; Contains: 08809840720046; Package: Cardboard [10 Units]; In Commercial Distribution
GS1	38809840720047 [Package]; Contains: 08809840720046; Package: Cardboard [20 Units]; In Commercial Distribution
GS1	48809840720044 [Package]; Contains: 08809840720046; Package: Cardboard [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241963

FDA Product Code

• EHD: Unit, X-Ray, Extraoral With Timer

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: 2024-11-01
• Device Publish Date: 2024-10-24

Devices Manufactured by PICOPACK Inc.

• 18809840720043 - WeRay: 2024-11-01WERAY is a battery-operated, portable dental X-ray source designed for handheld operation. It is intended to produce diagnostic-quality X-ray images. The WERAY is designed for use in a dental office. It can also be used in other similar environments (orthodontic office, general practitioner’s office, hospital ward, etc.) where appropriate safeguards are implemented. The device uses a rechargeable battery to allow the WERAY to be used. Still, transportation or using other X-ray devices might be prohibitive due to the other devices’ size and/or lack of mobility. The WERAY is an X-ray device with an AC/DC adaptor. The handheld device features a main body (tube head), a Cone for the sensor, Acryl shielding, a cradle, a Hand switch for X-ray exposure, and an AC/DC adaptor. The power is supplied by a rechargeable Lithium-ion polymer battery pack built into a main body. This facilitates the portability of the device. A beam-limiting cone is incorporated within the device. The acryl shielding provides sufficient radiation protection to allow the clinician to remain in the operatory with the patient. A hand switch is available to expose X-rays in a location away from the device. WERAY uses a fixed tube voltage of 70kV and a fixed tube current of 2.0 mA to make the system as simple as possible for the operator. The only operator-adjustable parameter is the exposure time. This adjustment can be quickly accomplished through the user-friendly control panel. Control buttons, a display panel, and an exposure button provide the primary operator interface. Exposure settings can be selected and displayed. The tube voltage (70 kV) and tube current (2.0 mA) are fixed, with the exposure time varying based on patient type, detector type, and anatomical features. Exposures can be completed using the exposure button. The WERAY should be used with an X-ray detector and a digital intraoral sensor. But the X-ray detector is not included in the device package.
• 18809840720043 - WeRay: 2024-11-01 WERAY is a battery-operated, portable dental X-ray source designed for handheld operation. It is intended to produce diagnostic-
• 08809840720008 - WeSensor: 2023-12-05 The WeSensor is an intraoral digital x-ray sensor. This model uses a scintillator made from Gadolinium Oxysulfide (Gd2O2S:Tb), a
• 08809840720015 - WeSensor: 2023-12-05 The WeSensor is an intraoral digital x-ray sensor. This model uses a scintillator made from Thallium-doped Cesium Iodide (CsI:Tl
• 08809840720022 - WeSensor: 2023-12-05 The WeSensor is an intraoral digital x-ray sensor. This model uses a scintillator made from Thallium-doped Cesium Iodide (CsI:Tl
• 08809840720039 - WeSensor: 2023-12-05 The WeSensor is an intraoral digital x-ray sensor. This model uses a scintillator made from Gadolinium Oxysulfide (Gd2O2S:Tb), a