FDA.reportPublic FDA data

EzRay M

Primary DI
08800016401288
Brand
EzRay M
Company
VATECH CO., LTD.
Model
VMX-P300
Device description
VMX-P300 PORTABLE X-RAY SYSTEM (EzRay M)
Published
2023-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IZLSystem, X-Ray, Mobile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZLSystem, X-Ray, MobileRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203667000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203667000EzRay M (Model: VMX-P300)VATECH Co., Ltd.2021-02-02IZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800016401288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800016401288088000164012888800016401288

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held intraoral dental x-ray system, digitalA diagnostic dental x-ray system designed to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. It is designed to be easily carried from location to location by a single operator. The sensor is placed in the mouth, the purpose being to visualize a limited region in detail. The data is either from analogue imaging and digitized afterwards or by digital imaging.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure86 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure86 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689229516
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800016401936Green X 12 SEPHT-40CHS2026-06-01
08800016401943Green X 12 SEPHT-40CHS2026-06-01
08800016401974Green X 21PHT-90CHO2025-11-12
08800016401981Green X 21PHT-90CHO2025-11-12
08800016401950VistaPano S 2.0VistaPano S2024-12-13
08800016401967VistaPano S Ceph 2.0VistaPano S Ceph2024-12-13
08800016400304ProVecta S-PanProVecta S-Pan2016-09-16
08800016400311ProVecta S-PanProVecta S-Pan2016-09-16
08800016400328ProVecta HDProVecta HD2016-09-16
08800016400335ProVecta HDProVecta HD2016-09-16
08800016400342ProVecta HDProVecta HD2016-09-16
08800016401875VistaIntra DCVistaIntra DC2023-06-16
08800016401882VistaIntra DCVistaIntra DC2023-06-16
08800016401899VistaIntra DCVistaIntra DC2023-06-16
08800016400069PaX-i3D GreenPHT-60CFO2016-09-16
08800016400076PaX-i3D GreenPHT-60CFO2016-09-16
08800016400083PaX-i3D GreenPHT-60CFO2016-09-16
08800016400090PaX-i3D GreenPHT-60CFO2016-09-16
08800016400106PaX-i3D GreenPHT-60CFO2016-09-16
08800016400137PaX-i3D GreenPHT-60CFO2016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850079606081MC2 Portable X-ray SystemOXOS Medical, Inc.IZL2026-09-21
00850079606098EmitterOXOS Medical, Inc.IZL2026-09-21
00850079606104CassetteOXOS Medical, Inc.IZL2026-09-21
08800098700187XLITEGEMSS Healthcare Co., Ltd.IZL2026-08-26
G221500MC009H0iQ FlexFirst Source, Inc.IZL2026-08-25
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401603SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401634SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401658SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401702SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401719SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396410124SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
08800011150129DRGEMDRGEM CorporationIZL2026-05-20
08800011150136DRGEMDRGEM CorporationIZL2026-05-20
07350011170005TrueMobileSolutions For Tomorrow ABIZL2026-05-18
08800184900002X-RAYNEUF Inc.IZL2026-05-11
08800184900019X-RAYNEUF Inc.IZL2026-05-11
08908021109097PRORAD ATLAS ULTRAPORTABLEPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDIZL2026-05-07
08908021109103PRORAD ATLAS ULTRAPORTABLE PLUSPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDIZL2026-04-16
08800040900108Diagnostic X-ray UnitPoskom Co., Ltd.IZL2026-04-15
08800040900221Airbile-100Poskom Co., Ltd.IZL2026-04-15
08800040900245AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900252AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900269AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900276AirRay-miniPoskom Co., Ltd.IZL2026-04-15
00850079606043MC2 Portable X-ray SystemOXOS Medical, Inc.IZL2026-03-25
00850079606050EmitterOXOS Medical, Inc.IZL2026-03-25