FDA.report

510(k) K210956

Device
Kubtec Mozart (XPERT42)
Applicant
Kub Technologies, Inc.
510(k) number
K210956
Product code
MWP
Decision
Substantially Equivalent (SESE)
Decision date
2021-08-31
Date received
2021-03-30
Regulation
892.1680
Classification name
Cabinet, X-Ray System
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Chester Lowe
Address
111 Research Dr. Stratford CT US 06615 06615

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code MWP

510(k)DeviceApplicantDecision date
K230140TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)Compai Healthcare (Suzhou) Co.,Ltd2023-04-24
K230136TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)Compai Healthcare (Suzhou) Co.,Ltd2023-04-24
K213691Solas ORCirdan Imaging, Ltd.2021-12-22
K210955Kubtec Mozart Supra (XPERT 84) Radiography SystemKub Technologies, Inc.2021-09-20
K210957Kubec Xpert 80 Radiography SystemKub Technologies, Inc.2021-08-31
K202713TrueView 100 ProCompai Healthcare (Shenzhen) Co.,Ltd2020-11-18
K200756Kubtec Mozart SupraKub Technologies, Inc.2020-06-12
K192939Volumetric Specimen ImagerClarix Imaging2019-12-27
K193317CoreLite X-Ray Specimen CabinetCirdan Imaging Limited2019-12-13
K183624Kubtec Mozart (Xpert42)Kub Technologies, Inc.2019-06-20
K183142PathVisionXLFaxitron Bioptics, LLC2019-03-14
K182727Trident HD Specimen Radiography SystemHologic, Inc.2019-01-10
K173309Faxitron VisionCTFaxitron Bioptics, LLC2018-05-09
K170786Faxitron Bioptics Speciemen Radiography SystemFaxitron Bioptics, LLC2017-07-18
K153583BioVision PlusFaxitron Bioptics, LLC2016-04-01