FDA.reportPublic FDA data

KUBTEC

Primary DI
B619KUB2500
Brand
KUBTEC
Company
Kubtec
Model
KUB250
Device description
mobile 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
IZLSystem, X-Ray, Mobile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZLSystem, X-Ray, MobileRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141539000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141539000KUBTEC X250Kub Technologies, Inc.2014-10-29IZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B619KUB2500PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Mobile basic diagnostic x-ray system, digitalAn assembly of devices that comprise a digital general-purpose mobile diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation and the mobile design allows it to operate on mains or battery power and to be driven or pushed by an operator to various locations within a building or facility. It is commonly used for bedside imaging and for interventional and intraoperative imaging. It consists of basic modular configurations that can be upgraded. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.

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
08800011150129DRGEMDRGEM CorporationIZL2026-05-20
08800011150136DRGEMDRGEM CorporationIZL2026-05-20
07350011170005TrueMobileSolutions For Tomorrow ABIZL2026-05-18
08800184900002X-RAYNEUF Inc.IZL2026-05-11
08800184900019X-RAYNEUF Inc.IZL2026-05-11
08908021109097PRORAD ATLAS ULTRAPORTABLEPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDIZL2026-05-07
08908021109103PRORAD ATLAS ULTRAPORTABLE PLUSPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDIZL2026-04-16
08800040900108Diagnostic X-ray UnitPoskom Co., Ltd.IZL2026-04-15
08800040900221Airbile-100Poskom Co., Ltd.IZL2026-04-15
08800040900245AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900252AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900269AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900276AirRay-miniPoskom Co., Ltd.IZL2026-04-15
00850079606043MC2 Portable X-ray SystemOXOS Medical, Inc.IZL2026-03-25
00850079606050EmitterOXOS Medical, Inc.IZL2026-03-25
04547410571134FDR AQROFUJIFILM CORPORATIONIZL2026-03-20
00858340006479Del Medical, Inc.Del Medical, Inc.IZL2026-03-05
08800060100229REMEX Xcam6REMEDI CO.,LTD.IZL2026-01-22
04056869297309MOBILETT ImpactSiemens Healthcare GmbHIZL2025-11-20
08800011150105DRGEMDRGEM CorporationIZL2025-08-26
08800011150112DRGEMDRGEM CorporationIZL2025-08-26
08800070400074HnX-P1H&abyz Co., LtdIZL2025-08-12
08800070400166HnX-PBH&abyz Co., LtdIZL2025-08-12
08436046003651SEDECALSEDECALIZL2025-03-21
08436046003668SEDECALSEDECALIZL2025-03-21
08436046003675SEDECALSEDECALIZL2025-03-21
08436046003682SEDECALSEDECALIZL2025-03-21
08436046003699SEDECALSEDECALIZL2025-03-21
08436046003705SEDECALSEDECALIZL2025-03-21
08436046003712SEDECALSEDECALIZL2025-03-21