FDA.reportPublic FDA data

Green X 21

Primary DI
08800016401981
Brand
Green X 21
Company
VATECH CO., LTD.
Model
PHT-90CHO
Device description
PHT-90CHO(OS21X19)/P(JUPI1012X)+C(VENU1012VD)+CT+TUBE/MASTER
Published
2025-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OASX-Ray, Tomography, Computed, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OASX-Ray, Tomography, Computed, DentalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243081000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243081000Green X 21 (PHT-90CHO)VATECH Co., Ltd.2025-02-14OAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800016401981PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800016401981088000164019818800016401981

GMDN Terms#

Term, Definition table
TermDefinition
Stationary panoramic/tomographic dental x-ray system, digitalA diagnostic digital dental x-ray system designed for permanent fixture in one location with an extraoral x-ray sensor and source intended to generate and control x-ray beams used in advanced dental imaging applications involving the teeth, jaw, oral cavity, sinus, and/or other maxillofacial structures. It uses digital techniques for image capture, manipulation and display and may include various image processing and analysis capabilities. This system is designed with the capability to produce two or more special purpose dental x-ray examinations: linear scanning, panoramic, cephalometric, linear tomography, spiral tomography, scanograms.

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 Celsius55 Degrees Celsius

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
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
08800016400205PaX-i3DPHT-65002016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975066322066MeyerHefei Meyer Optoelectronic Technology Inc.OAS2026-09-30
06975066322080MeyerHefei Meyer Optoelectronic Technology Inc.OAS2026-09-30
06975066322097MeyerHefei Meyer Optoelectronic Technology Inc.OAS2026-09-30
06975066322103MeyerHefei Meyer Optoelectronic Technology Inc.OAS2026-09-30
00854810007168CLARISIcRco, Inc.OAS2026-07-22
08800016401936Green X 12 SEVATECH CO., LTD.OAS2026-06-01
08800016401943Green X 12 SEVATECH CO., LTD.OAS2026-06-01
60192155951237CS 9600CARESTREAM DENTAL LLCOAS2026-05-15
60192155951244CS 9600CARESTREAM DENTAL LLCOAS2026-05-15
E27668234830Primevision 3DSIRONA Dental Systems GmbHOAS2026-04-30
D804W1203005DRT0X-MIND optima 3DDE GÖTZEN SRLOAS2026-03-23
D804W1203005FLDRT0X-MIND optima 3DDE GÖTZEN SRLOAS2026-03-23
D804W1203010DRT0X-MIND optima 3DDE GÖTZEN SRLOAS2026-03-23
D804W1203015DRT0X-MIND optima 3DDE GÖTZEN SRLOAS2026-03-23
D804W1203015FLDRT0X-MIND optima 3DDE GÖTZEN SRLOAS2026-03-23
D804W1203020DRT0X-MIND optima 3DDE GÖTZEN SRLOAS2026-03-23
08033837934981myrayCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
08033837935001myrayCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
08033837936091NewTomCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
08033837936107NewTomCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
08033837936176CastelliniCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
08033837936411CastelliniCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
E27668234260Primevision 3DSIRONA Dental Systems GmbHOAS2026-02-13
00990010312418DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312562DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312579DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312586DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312593DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312609DURAYBeyes Dental Canada IncOAS2025-12-15
08800003027026RAYSCANRay Co., LtdOAS2025-12-01