FDA.reportPublic FDA data

Xray2Go

Primary DI
00858475006009
Brand
Xray2Go
Company
DENTERPRISE INTERNATIONAL, INC.
Model
Xray2Go 3mA
Device description
Indications for Use: The Portable X-ray system (Model: EXARO, Xray2GO) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.
Published
2017-02-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHDUnit, X-Ray, Extraoral With Timer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHDUnit, X-Ray, Extraoral With TimerDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141497000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141497000PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO)Osstem Implant Co., Ltd.2014-08-26EHD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858475006009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858475006009008584750060098584750060090858475006009

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-323-2690info@denterpriseintl.com

Regulatory Flags#

DUNS number
024913248
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858475006337Smil-O-Ray12024-01-05
00858475006269QuickRay DX Size 1102QDX203002023-07-25
00858475006276QuickRay DX Size 2202QDX204002023-07-25
00858475006115iCam100001MAG100002022-02-03
00858475006177InstaRaySize 102HAM151022019-07-24
00858475006184InstaRaySize 202HAM153022019-07-24
00858475006016QuickRay HD #2Hama Size #22017-02-01
00858475006023QuickRay HD #1Hama Size #12017-02-01
00858475006030Uni-Ray HDHDI-S 1.52017-02-17
00858475006047 Quick Ray HD No Logo #1S11684-12 Hama Size #12017-02-01
00858475006054 QUICK Ray HD No Logo #2S11685-12 Hama Size #22017-02-01
00858475006078QuickRay #1e2V Size #12017-02-01
00858475006085QuickRay #2e2V Size #22017-01-31
00858475006092Xray2Go MiniMiniX-V2017-02-01
00858475006153MOBILE-XT1002018-05-29
00858475006139EZ-FlowEZ-Flow2018-03-19
00858475006146AcuflowAcuflow2018-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941877830557EighteethChangzhou Sifary Medical Technology Co., Ltd.EHD2026-10-08
08800000995809N1Osstem Implant Co.,Ltd.EHD2026-08-27
07899581361289Evolve PortableAlliage S/A Indústrias Médico OdontológicaEHD2026-08-22
08800021800168XTGDigiMed Co., Ltd.EHD2026-06-01
08800021800175XTG VDigiMed Co., Ltd.EHD2026-06-01
D090800047970NOMAD Pro 3 X-Ray Tubehead, USDental Imaging Technologies CorporationEHD2026-03-31
D090800048750NOMAD Pro 3 Packaged System, USDental Imaging Technologies CorporationEHD2026-03-31
D090800048870NOMAD Pro 3 Packaged System, US Dental Imaging Technologies CorporationEHD2026-03-31
08809840720046WeRayPICOPACK Inc.EHD2024-10-24
08800021800045BIOXDigiMed Co., Ltd.EHD2024-06-12
08800021800106HYBRID S70DigiMed Co., Ltd.EHD2024-06-12
08800021800120XTG PRO 70DigiMed Co., Ltd.EHD2024-06-12
08800021800137DHX-70HDigiMed Co., Ltd.EHD2024-06-12
07899581344695EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaEHD2023-12-08
07899581344701EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaEHD2023-12-08
07899581340253Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340260Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340284Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340697Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340727Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
08800021800113xm-liteDigiMed Co., Ltd.EHD2022-12-01
08800124900000CLAROXVSI Co., Ltd.EHD2022-07-25
08800072313211Portable Dental X-ray (CS 2400P)NANORAY CO.,LTDEHD2021-02-18
08800072313310Portable Dental X-ray (CS 2300P)NANORAY CO.,LTDEHD2021-02-18
08800072313419Portable Dental X-ray (NR-F350 with Back scatter shield)NANORAY CO.,LTDEHD2021-02-18
08800072313518Portable Dental X-ray (R2 Port-X without Back scatter shield)NANORAY CO.,LTDEHD2021-02-18
08800072313617Portable Dental X-ray (R2 Port-X with Back scatter shield)NANORAY CO.,LTDEHD2021-02-18
00841709112577MidmarkMIDMARK CORPORATIONEHD2021-01-15
00841709112713MidmarkMIDMARK CORPORATIONEHD2021-01-15
00841709112850MidmarkMIDMARK CORPORATIONEHD2021-01-15