FDA.reportPublic FDA data

KUBTEC

Primary DI
B619X200
Brand
KUBTEC
Company
Kubtec
Model
XPERT 20
Device description
specimen x-ray system
Published
2017-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPRSystem, X-Ray, Stationary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPRSystem, X-Ray, StationaryRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083510000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083510000KUBTEC XPERT 20Kub Technologies, Inc.2009-01-08KPR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B619X200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Specimen x-ray system IVDAn assembly of devices designed to produce an x-ray image of a tissue sample (e.g., stereotactic biopsy cores taken during mammographic procedures) and/or an amputated body part, by generating and controlling x-ray beams and recording the absorption patterns of the x-rays. The system typically includes a cabinet where the specimen is placed and a screen; the image is generated via digital imaging methods.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2033648544apangaio@kubtec.com

Regulatory Flags#

DUNS number
361955128
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B619K0030C010Kubbie 3D Specimen ManagerK0030C012026-04-30
B619A90000102Kubbie Container and Nodes & Shaves TrayA90-00012026-04-27
B619A90000304Kubbie Specimen Membranes and Orientation MarkersA90-00022026-04-27
B619A90000506Kubbie Specimen Membranes and Orientation MarkersA90-00022026-04-27
B619A9000203Kubbie Specimen Membranes and Orientation MarkersA90-00022026-04-27
B619X42QK0XPERT42XPERT 422025-03-26
B619X80LAR0XPERT80LXPERT 80L2025-03-26
B619X80QT0XPERT80XPERT 802025-03-26
B619X84R3XPERT84XPERT842025-03-26
B619K0018C01UP0GammaPro Straight Standard ProbeK0018C012025-03-26
B619K0019C01UW0GammaPro High Sensitivity ProbeK0019C012025-03-26
B619K0020C01TA0GammaPro Laparoscopic ProbeK0020C012025-03-26
B619K0021C01TH0GammaPro Angled Standard ProbeK0021C012025-03-26
B619X20Q9XPERT20XPERT 202025-03-26
B619X40QF0XPERT40XPERT 402025-03-26
B619GPROHISKIT0GammaPro Hi-Sense Probe with Tablet and Carry Case K0019C022022-10-14
B619GPROHISPROBE0GammaPro High Sensitivity ProbeK0019C012022-10-14
B619GPROLAPKIT0GammaPro Laparoscopic Probe with Tablet and Carry CaseK0020C022022-10-14
B619GPROLAPPROBE0GammaPro Laparoscopic ProbeK0020C012022-10-14
B619GPROSTDANGPROBE0GammaPro Angled Standard ProbeK0021C012022-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08908021109004PRORAD 3NCPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDKPR2026-05-07
08908021109011PRORAD 2FCPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDKPR2026-05-07
08809365280001SG HealthcareSG Healthcare Co., Ltd.KPR2026-04-24
08809365281015SG HealthcareSG Healthcare Co., Ltd.KPR2026-04-24
00198953056103DefiniumGE Hualun Medical Systems Co., LtdKPR2026-02-12
00198953056158DefiniumGE Hualun Medical Systems Co., LtdKPR2026-02-12
04056869297309MOBILETT ImpactSiemens Healthcare GmbHKPR2025-11-20
00195278913807DefiniumGE Hualun Medical Systems Co., LtdKPR2024-10-30
00195278840226DiscoveryGE Hualun Medical Systems Co., LtdKPR2024-07-04
04540217071319RADspeed ProSHIMADZU CORPORATIONKPR2024-04-01
04540217071326RADspeed ProSHIMADZU CORPORATIONKPR2024-04-01
04540217071333RADspeed ProSHIMADZU CORPORATIONKPR2024-04-01
04540217071340RADspeed ProSHIMADZU CORPORATIONKPR2024-04-01
04540217071357RADspeed ProSHIMADZU CORPORATIONKPR2024-04-01
00195278526892DefiniumGE Hualun Medical Systems Co., LtdKPR2023-09-18
00884838110588Precision CRFPhilips Medical Systems DMC GmbHKPR2023-02-14
B216DRH700AC1X-CEL X-RAY CORPORATIONARQUILLA, INC.KPR2022-12-20
00884838103221ProxiDiagnost N90Philips Medical Systems DMC GmbHKPR2022-01-17
08436046003026SEDECALSEDECALKPR2021-02-15
08436046003033SEDECALSEDECALKPR2021-02-15
00195278070265DefiniumGE Hualun Medical Systems Co., LtdKPR2020-11-24
00810035220386Radmedix AcuityFDRRADMEDIX, LLCKPR2020-09-18
00810035220393Radmedix AcuityFDR+RADMEDIX, LLCKPR2020-09-18
00810035220409Radmedix AcuityCDRRADMEDIX, LLCKPR2020-09-18
00810035220416Radmedix AcuitySDRRADMEDIX, LLCKPR2020-09-18
00810035220423Radmedix AcuitySDR+RADMEDIX, LLCKPR2020-09-18
00810030350071uDRUIH TECHNOLOGIES LLCKPR2020-05-26
00810030350002uDRUIH TECHNOLOGIES LLCKPR2020-04-29
08800011121235FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121242FDR ClinicaDRGEM CorporationKPR2019-11-20