WeRay

Primary DI
08809840720046
Brand
WeRay
Company
PICOPACK Inc.
Model
P70A
Device description
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 radiationprotection 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.
Published
2024-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHDUnit, X-Ray, Extraoral With Timer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHDUnit, X-Ray, Extraoral With TimerDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241963000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241963000WERAYPicopack Co., Ltd.2024-07-30EHD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809840720043PackageGS15In Commercial Distribution
28809840720040PackageGS110In Commercial Distribution
38809840720047PackageGS120In Commercial Distribution
48809840720044PackageGS150In Commercial Distribution
08809840720046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880984072004318809840720043
2880984072004028809840720040
3880984072004738809840720047
4880984072004448809840720044
08809840720046088098407200468809840720046

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held intraoral dental x-ray system, digitalA diagnostic dental x-ray system designed to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. It is designed to be easily carried from location to location by a single operator. The sensor is placed in the mouth, the purpose being to visualize a limited region in detail. The data is either from analogue imaging and digitized afterwards or by digital imaging.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth106Millimeter
Height269Millimeter
Width302Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Handling Environment Humidity5 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+82423625056cs@picopack.co.kr

Regulatory Flags#

DUNS number
694616916
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18809840720043WeRayP70A2024-10-24
08809840720008WeSensorG350A2023-11-27
08809840720015WeSensorF350A2023-11-27
08809840720022WeSensorF150A2023-11-27
08809840720039WeSensorG150A2023-11-27

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Primary DI, Brand, Company table
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D090800048870NOMAD Pro 3 Packaged System, US Dental Imaging Technologies CorporationEHD2026-03-31
08800021800045BIOXDigiMed Co., Ltd.EHD2024-06-12
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