FDA.reportPublic FDA data

510(k) K183142

Device
PathVisionXL
Applicant
Faxitron Bioptics LLC
510(k) number
K183142
Product code
MWP  
Decision
Substantially Equivalent (SESE)
Decision date
2019-03-14
Date received
2018-11-13
Regulation
892.1680
Classification name
Cabinet, X-ray System
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ciaran Purdy
Address
3440 E. Britannia Dr., Suite 150 Tucson AZ US 85706 85706

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MWP  #

510(k), Device, Applicant table
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
K210956Kubtec Mozart (XPERT42)Kub 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
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