FDA.reportPublic FDA data

Genoray

Primary DI
08809244060021
Brand
Genoray
Company
GENORAY CO., LTD.
Model
ZEN-2090 Pro
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JAASystem, X-Ray, Fluoroscopic, Image-Intensified
OXOImage-Intensified Fluoroscopic X-Ray System, Mobile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
OXOImage-Intensified Fluoroscopic X-Ray System, MobileRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091918000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091918000ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PROGenoray Co., Ltd.2009-10-07OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809244060021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809244060021088092440600218809244060021

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
631064672
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809244061103GenorayPAPAYA2016-12-28
08809244061110GenorayPAPAYA Plus2016-09-24
08809244061127GenorayPAPAYA 3D2016-12-28
08809244061134GenorayPAPAYA 3D Plus2016-09-24
08809244060533GenorayBELLIGER ACE2026-04-10
08809244060557GenorayAREX2026-04-10
08809244060632GenorayVETERA ACE2026-04-10
08809244060076GenorayGenX-CR2023-09-25
08809244060335GenorayGT3002025-12-01
08809244060472GenorayGT300-C2025-12-01
08809244060601GenorayVETERA FD2025-12-01
08809244060618GenorayVETERA PRIME2025-12-01
08809244060625GenorayVETERA CLASSIC2025-12-01
08809244060649GenorayVETERA DW2025-12-01
08809244060656GenorayVETERA DM2025-12-01
08809244060663GenorayVETERA PX2025-12-01
08809244060670GenorayVETERA PE2025-12-01
08809244060700GenorayVETERA TURBO2025-12-01
08809244065088GenorayHESTIA2025-07-24
08809244060090GenorayZEN-2090 Turbo2025-05-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00680211003313PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2026-10-12
00680211003306PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2026-09-22
00680211003290PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2026-09-21
00850079606081MC2 Portable X-ray SystemOXOS Medical, Inc.OXO2026-09-21
00850079606098EmitterOXOS Medical, Inc.OXO2026-09-21
00850079606104CassetteOXOS Medical, Inc.OXO2026-09-21
04547410582901FDR CROSS SlimFUJIFILM CORPORATIONJAA2026-08-14
00854810007199iXRSIcRco, Inc.JAA2026-07-22
00860014944611nView s1 with nav optionNVIEW MEDICAL INC.JAA2026-07-08
00860014944611nView s1 with nav optionNVIEW MEDICAL INC.OXO2026-07-08
00680211003276PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2026-07-06
00848340021879Mitaka DrapeADVANCE MEDICAL DESIGNS, INC.JAA2026-06-25
08055186671225A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOXO2026-05-21
08055186671232A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOXO2026-05-21
08055186671249A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOXO2026-05-21
08055186671256A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOXO2026-05-21
B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.OXO2026-04-30
B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.JAA2026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.JAA2026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.OXO2026-04-30
08809244060533GenorayGENORAY CO., LTD.JAA2026-04-10
08809244060557GenorayGENORAY CO., LTD.JAA2026-04-10
08809244060632GenorayGENORAY CO., LTD.JAA2026-04-10
08809244060618GenorayGENORAY CO., LTD.JAA2025-12-01
08809244060625GenorayGENORAY CO., LTD.JAA2025-12-01
08809244060700GenorayGENORAY CO., LTD.JAA2025-12-01
08809244060700GenorayGENORAY CO., LTD.OXO2025-12-01
04056869993973LUMINOS Q.namix RSiemens Healthcare GmbHJAA2025-07-30
04056869993980LUMINOS Q.namix TSiemens Healthcare GmbHJAA2025-07-30
B225100000200Orthoscan Versa Mini C-ArmZiehm-Orthoscan, Inc.OXO2025-07-11