CLAROX VX-30

GUDID 18800124900007

CLAROX is a battery-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-ray images. The CLAROX 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 for the use of the CLAROX where transportation or use of other x-ray devices might be prohibitive due to the other device’s size and/or lack of mobility. The CLAROX is an X-ray device with an AC/DC adaptor. The handheld device features a main body (tube head), Cone for sensor, Acryl shielding, cradle, and AC/DC adaptor.

VSI Co., Ltd.

Hand-held intraoral dental x-ray system, digital

• Primary Device ID: 18800124900007
• NIH Device Record Key: b5d986c9-cd8e-475d-b926-23150e224915
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLAROX
• Version Model Number: VX-30
• Catalog Number: VX-30
• Company DUNS: 690151865
• Company Name: VSI 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

Customer Support Contacts

• Phone: +82432679039
• Email: sales@vsi.co.kr
• Phone: +82432679039
• Email: sales@vsi.co.kr
• Phone: +82432679039
• Email: sales@vsi.co.kr
• Phone: +82432679039
• Email: sales@vsi.co.kr
• Phone: +82432679039
• Email: sales@vsi.co.kr
• Phone: +82432679039
• Email: sales@vsi.co.kr
• Phone: +82432679039
• Email: sales@vsi.co.kr
• Phone: +82432679039
• Email: sales@vsi.co.kr
• Phone: +82432679039
• Email: sales@vsi.co.kr

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800124900000 [Primary]
GS1	18800124900007 [Package]; Contains: 08800124900000; Package: Cardboard box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221286

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: 2022-08-02
• Device Publish Date: 2022-07-25

Devices Manufactured by VSI Co., Ltd.

• 18800124900014 - CLAROX plus: 2022-10-11 VX-100 is a battery-operated, portable X-ray source designed for handheld operation. It is designed to produce diagnostic qualit
• 18800124900007 - CLAROX: 2022-08-02CLAROX is a battery-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-ray images. The CLAROX 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 for the use of the CLAROX where transportation or use of other x-ray devices might be prohibitive due to the other device’s size and/or lack of mobility. The CLAROX is an X-ray device with an AC/DC adaptor. The handheld device features a main body (tube head), Cone for sensor, Acryl shielding, cradle, and AC/DC adaptor.
• 18800124900007 - CLAROX: 2022-08-02 CLAROX is a battery-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic