CLAROX plus

GUDID 18800124900014

VX-100 is a battery-operated, portable X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-ray images. The VX-100 is designed for use in general-purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams. Because of its low power output, the CLAROX plus (Model VX-100) is intended for exclusive use on body extremities. The functions of the VX-100 handheld system are supported by software (firmware).

VSI Co., Ltd.

Portable basic diagnostic x-ray system, digital Portable basic diagnostic x-ray system, digital Portable basic diagnostic x-ray system, digital Portable basic diagnostic x-ray system, digital Portable basic diagnostic x-ray system, digital Portable basic diagnostic x-ray system, digital Portable basic diagnostic x-ray system, digital Portable basic diagnostic x-ray system, digital Portable basic diagnostic x-ray system, digital Portable basic diagnostic x-ray system, digital

• Primary Device ID: 18800124900014
• NIH Device Record Key: c3543bf4-e25e-465a-9b49-ee6384cfad23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLAROX plus
• Version Model Number: VX-100
• 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

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800124900017 [Primary]
GS1	18800124900014 [Package]; Contains: 08800124900017; Package: Cardboard Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221417

FDA Product Code

• IZL: System, X-Ray, Mobile

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: 2022-10-11
• Device Publish Date: 2022-10-03

Devices Manufactured by VSI Co., Ltd.

• 18800124900014 - CLAROX plus: 2022-10-11VX-100 is a battery-operated, portable X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-ray images. The VX-100 is designed for use in general-purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams. Because of its low power output, the CLAROX plus (Model VX-100) is intended for exclusive use on body extremities. The functions of the VX-100 handheld system are supported by software (firmware).
• 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: 2022-08-02 CLAROX is a battery-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic