BONX805, DIONE-X80 Portable X-ray Imaging Device

GUDID 08800069500105

bontech Inc

Portable basic diagnostic x-ray system, digital

• Primary Device ID: 08800069500105
• NIH Device Record Key: d9ea7b06-31a2-40f5-9121-4aef20c28f7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BONX805, DIONE-X80 Portable X-ray Imaging Device
• Version Model Number: BONX805, DIONE-X80
• Company DUNS: 689050426
• Company Name: bontech Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800069500105 [Primary]

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

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: 2025-12-11
• Device Publish Date: 2025-12-03

Devices Manufactured by bontech Inc

• 08800069500105 - BONX805, DIONE-X80 Portable X-ray Imaging Device: 2025-12-11
• 08800069500105 - BONX805, DIONE-X80 Portable X-ray Imaging Device: 2025-12-11
• 08800069500013 - BSD3543 Digital Flat Panel X-ray Detector: 2025-09-19
• 08800069500020 - BSD3543 Digital Flat Panel X-ray Detector: 2025-09-19
• 08800069500037 - BSD4343R Digital Flat Panel X-ray Detector: 2025-09-19
• 08800069500044 - BSD4343R Digital Flat Panel X-ray Detector: 2025-09-19
• 08800069500051 - BSD3543W Digital Flat Panel X-ray Detector: 2025-09-19
• 08800069500068 - BSD3543W Digital Flat Panel X-ray Detector: 2025-09-19