BIOX

GUDID 18800021800042

The portable x-ray system, BIOX is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software. And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images.

DigiMed Co., Ltd.

Diagnostic x-ray system generator, portable

• Primary Device ID: 18800021800042
• NIH Device Record Key: 6eaebfbf-54fa-4281-9f3b-1b703fcdb1e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOX
• Version Model Number: 1
• Company DUNS: 688265810
• Company Name: DigiMed 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 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 21 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 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 21 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 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 21 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 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 21 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 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 21 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 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 21 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 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 21 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 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 21 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 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 21 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 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 21 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 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 21 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 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 21 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 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 21 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 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 21 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 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 21 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 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 21 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 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 21 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 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800021800045 [Primary]
GS1	18800021800042 [Package]; Contains: 08800021800045; Package: Carton box [1 Units]; In Commercial Distribution
GS1	28800021800049 [Package]; Contains: 08800021800045; Package: Carton box [2 Units]; In Commercial Distribution
GS1	38800021800046 [Package]; Contains: 08800021800045; Package: Carton box [3 Units]; In Commercial Distribution
GS1	48800021800043 [Package]; Contains: 08800021800045; Package: Carton box [4 Units]; In Commercial Distribution
GS1	58800021800040 [Package]; Contains: 08800021800045; Package: Carton box [5 Units]; In Commercial Distribution
GS1	68800021800047 [Package]; Contains: 08800021800045; Package: Carton box [6 Units]; In Commercial Distribution
GS1	78800021800044 [Package]; Contains: 08800021800045; Package: Carton box [7 Units]; In Commercial Distribution
GS1	88800021800041 [Package]; Contains: 08800021800045; Package: Carton box [8 Units]; In Commercial Distribution

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: 2024-06-20
• Device Publish Date: 2024-06-12

Devices Manufactured by DigiMed Co., Ltd.

• 18800021800042 - BIOX: 2024-06-20The portable x-ray system, BIOX is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software. And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images.
• 18800021800042 - BIOX: 2024-06-20 The portable x-ray system, BIOX is an x-ray generating device which is mainly designed for dental examination. So the device can
• 18800021800103 - HYBRID S70: 2024-06-20 The portable x-ray system, HYBRID S70 is an x-ray generating device which is mainly designed for dental examination. So the devi
• 18800021800127 - XTG PRO 70: 2024-06-20 The portable x-ray system, HYBRID Pro is an x-ray generating device which is mainly designed for dental examination. So the devi
• 18800021800134 - DHX-70H: 2024-06-20 The portable x-ray system, DHX-70H is an x-ray generating device which is mainly designed for dental examination. So the device
• 78800021800006 - PROX: 2023-12-25 The PROX is a hand-held diagnostic dental x-ray system. It is intended to be used by trained dentists and dental technicians as
• 08800021800014 - DIOX-602: 2023-12-25 The DIOX-602 is a hand-held diagnostic dental x-ray system. It is intended to be used by trained dentists and dental technicians
• 18800021800110 - xm-lite: 2022-12-09 The portable x-ray system, HYBRID C70 is an x-ray generating device which is mainly designed for dental examination. So the devi
• 88800021800027 - MiniX-S: 2019-04-01 The MiniX-S is an x-ray generating device which is mainly designed for dental examination. The device has an x-ray tube for gene