FDA.reportPublic FDA data

RAYSCAN STUDIO, Vision 20, RAYPreMiere, RAYSCAN S, Vision 18, RCT800

Primary DI
08800003027057
Brand
RAYSCAN STUDIO, Vision 20, RAYPreMiere, RAYSCAN S, Vision 18, RCT800
Company
Ray Co., Ltd
Model
RCT800
Published
2025-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K182805000
K192737000
K230753000
K260462000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182805000RCT800Ray Co., Ltd.2018-12-14OAS
K192737000RCT800Ray Co., Ltd.2019-10-22OAS
K230753000RCT800Ray Co., Ltd.2023-04-11OAS
K260462000RCT800Ray Co., Ltd.2026-04-09OAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800003027057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800003027057088000030270578800003027057

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690324087
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800003027026RAYSCANScan Ceph2025-12-01
08800003027002RAYSCAN α+, Vision 16, RCT700RCT7002025-08-25
08800003027019RAYSCANScan Ceph (SC)2025-08-25
08800003027033RAYSCANOne Shot Ceph Small2025-08-25
08800003027040RAYSCANOne Shot Ceph Large2025-08-25
08800003027088RAYSCAN α-Expert, RAYSCAN α-PRAYSCAN α-P2025-08-25
08800003027095RAYSCAN α-Expert 3D, RAYSCAN α-3DRAYSCAN α-3D2025-08-25
08800003027064RAYQuantum, RCT600RCT6002025-04-14
08800003027071RAYQuantumScan Ceph2025-04-14
08800003005017SMARTDent3.1.0.02025-05-28
08800003001002RAYSCAN α+RCT7002020-05-08
08800003004003RAYSCAN StudioRCT800 2020-05-08
08800003003013RIOScanRPS500 (STD)2016-10-05
08800003003020RIOScanRPS500 (OCC)2016-10-05
08800003003310RIOScanIP Size 0 2016-10-05
08800003003327RIOScanIP Size 12016-10-05
08800003003334RIOScanIP Size 22016-10-05
08800003003341RIOScanIP Size 32016-10-05
08800003003358RIOScanIP Size 42016-10-05
08800003003365RIOScanIP Size 1, 32016-10-05

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