FDA.reportPublic FDA data

KUBTEC

Primary DI
B619X420
Brand
KUBTEC
Company
Kubtec
Model
XPERT 42
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
MWPCabinet,X-Ray System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWPCabinet, X-Ray SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071233000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071233000XPERT 40 SPECIMEN RADIOGRAPHY SYSTEMKub Technologies, Inc.2007-06-20MWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B619X420PrimaryHIBCC0

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
B619A90000708Kubbie Nodes & Shaves TrayA90-00072026-10-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979294740036TrueViewCompAI MedTech (Suzhou) Co., Ltd.MWP2026-07-22
06979294740043TrueViewCompAI MedTech (Suzhou) Co., Ltd.MWP2026-07-22
05060508820062Solas ORCIRDAN IMAGING LIMITEDMWP2026-05-05
B619X40QF0XPERT40KubtecMWP2025-03-26
B619X42QK0XPERT42KubtecMWP2025-03-26
B619X80LAR0XPERT80LKubtecMWP2025-03-26
B619X80QT0XPERT80KubtecMWP2025-03-26
B619X84R3XPERT84KubtecMWP2025-03-26
00860007231605Clarix Imaging CorpsClarix Imaging CorporationMWP2024-08-01
15420045516656FAXITRON WEDGEHologic, Inc.MWP2023-05-25
06974970580074TrueViewCompAI Healthcare (Suzhou) Co.,ltdMWP2023-05-17
06974970580081TrueViewCompAI Healthcare (Suzhou) Co.,ltdMWP2023-05-17
25420045516622FAXITRON COREHologic, Inc.MWP2023-04-11
25420045516646FAXITRON MAMMOTOMEHologic, Inc.MWP2023-04-11
15420045516625FAXITRON COREHologic, Inc.MWP2023-04-11
15420045516649FAXITRON MAMMOTOMEHologic, Inc.MWP2023-04-11
15420045514898FAXITRON ULTRAFOCUSHologic, Inc.MWP2022-07-12
15420045514911Faxitron CTHologic, Inc.MWP2021-10-07
15420045514836FAXITRON PATHHologic, Inc.MWP2021-08-17
15420045514928Faxitron Path+Hologic, Inc.MWP2021-08-17
15420045515031FAXITRON PATHHologic, Inc.MWP2021-07-30
15420045514218FAXITRON COREHologic, Inc.MWP2021-07-15
06973166110026TrueViewCompAI Healthcare (Shenzhen) Co.,ltdMWP2021-01-22
00887868199097Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13
00887868199103Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13
00887868199110Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13
00887868199127Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13
00887868199134Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13
00887868199141Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13
00887868199158Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13