FDA.reportPublic FDA data

BONX805, DIONE-X80 Portable X-ray Imaging Device

Primary DI
08800069500105
Brand
BONX805, DIONE-X80 Portable X-ray Imaging Device
Company
bontech Inc
Model
BONX805, DIONE-X80
Published
2025-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800069500105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800069500105088000695001058800069500105

GMDN Terms#

Term, Definition table
TermDefinition
Portable basic diagnostic x-ray system, digitalAn assembly of devices that comprise a general-purpose portable diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The portable design allows it to operate on either mains or battery power and to be easily disassembled, moved from location to another, and easily reassembled for use. It consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689050426
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800069500013BSD3543 Digital Flat Panel X-ray DetectorBT-DA22-IA2025-09-11
08800069500020BSD3543 Digital Flat Panel X-ray DetectorBT-DB22-IA2025-09-11
08800069500051BSD3543W Digital Flat Panel X-ray DetectorBT-DA22W2025-09-11
08800069500068BSD3543W Digital Flat Panel X-ray DetectorBT-DB22W2025-09-11
08800069500037BSD4343R Digital Flat Panel X-ray DetectorBT-DA24-IA2025-09-11
08800069500044BSD4343R Digital Flat Panel X-ray DetectorBT-DB24-IA2025-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00854810007007AirDRIcRco, Inc.MQB2026-07-22
00854810007014AirDRIcRco, Inc.MQB2026-07-22
00854810007120iDRIcRco, Inc.MQB2026-07-22
00854810007205AirDRIcRco, Inc.MQB2026-07-22
08809394330906VIVIX-S 4386WVIEWORKS CO., LTD.MQB2026-07-16
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401603SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401634SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401658SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401702SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401719SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396410124SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
08057737122040Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08057737122057Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08800011150129DRGEMDRGEM CorporationMQB2026-05-20
08800011150136DRGEMDRGEM CorporationMQB2026-05-20
08809413811096ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811126ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811133ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.MQB2026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.MQB2026-04-30
08809365280001SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
08809365281015SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
08055186671089A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLMQB2026-04-02
00198953056103DefiniumGE Hualun Medical Systems Co., LtdMQB2026-02-12
00198953056158DefiniumGE Hualun Medical Systems Co., LtdMQB2026-02-12
00810035220546Radmedix AcuityDRe 1717tRADMEDIX, LLCMQB2025-10-28