FDA.report

510(k) K202713

Device
TrueView 100 Pro
Applicant
Compai Healthcare (Shenzhen) Co.,Ltd
510(k) number
K202713
Product code
MWP
Decision
Substantially Equivalent (SESE)
Decision date
2020-11-18
Date received
2020-09-16
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
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Wang Yan
Address
8b, Huangting Bldg., #355, Fuhua Rd., Futian St., Futian District Shenzhen CN 518026 518026

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
K210956Kubtec Mozart (XPERT42)Kub Technologies, Inc.2021-08-31
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