FDA.reportPublic FDA data

Genoray

Primary DI
08809244065088
Brand
Genoray
Company
GENORAY CO., LTD.
Model
HESTIA
Published
2025-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MUEFull Field Digital, System, X-Ray, Mammographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUEFull Field Digital, System, X-Ray, MammographicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243420000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243420000HESTIAGenoray Co., Ltd.2025-07-17MUE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809244065088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809244065088088092440650888809244065088

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
08809244060090GenorayZEN-2090 Turbo2025-05-02
08809244060199GenorayPAPAYA2025-05-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008548100070693600IcRco, Inc.MUE2026-07-22
08809394330807Bellalun 2DVIEWORKS CO., LTD.MUE2026-07-20
08052405210203SERENYS DRMETALTRONICA SPAMUE2026-05-25
08052405210050HELIANTHUSMETALTRONICA SPAMUE2026-03-24
00198953109281Senographe PristinaGE MEDICAL SYSTEMSMUE2025-12-01
10198953054311not applicableGE MEDICAL SYSTEMSMUE2025-11-28
15420045517851Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517882Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517899Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517905Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517912Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517929Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517936Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517943Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517950Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517967Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517974Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517981Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517998Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
08809394330357VIVIX-M 1824SVIEWORKS CO., LTD.MUE2025-07-15
08809394330364VIVIX-M 2430SVIEWORKS CO., LTD.MUE2025-07-15
088000186022562430TCARayence Co., Ltd.MUE2025-04-08
00195278914026Senographe PristinaGE MEDICAL SYSTEMSMUE2025-01-09
10195278901764Not ApplicableGE MEDICAL SYSTEMSMUE2025-01-09
00195278866899not applicableGE MEDICAL SYSTEMSMUE2024-06-07
04056869987187MAMMOMAT B.brilliantSiemens Healthcare GmbHMUE2024-04-20
00195278719812not applicableGE MEDICAL SYSTEMSMUE2024-04-11
00195278795724not applicableGE MEDICAL SYSTEMSMUE2024-01-22
00195278711229not applicableGE MEDICAL SYSTEMSMUE2023-09-14
00195278655141not applicableGE MEDICAL SYSTEMSMUE2023-07-28