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MWP — Cabinet, X-Ray System Class II

FDA Device Classification

Classification Details

Product Code
MWP
Device Class
Class II
Regulation Number
892.1680
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K230136compai healthcare (suzhou) coTrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)April 24, 2023
K230140compai healthcare (suzhou) coTrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-UApril 24, 2023
K213691cirdan imagingSolas ORDecember 22, 2021
K210955kub technologiesKubtec Mozart Supra (XPERT 84) Radiography SystemSeptember 20, 2021
K210957kub technologiesKubec Xpert 80 Radiography SystemAugust 31, 2021
K210956kub technologiesKubtec Mozart (XPERT42)August 31, 2021
K202713compai healthcare (shenzhen) coTrueView 100 ProNovember 18, 2020
K200756kub technologiesKubtec Mozart SupraJune 12, 2020
K192939clarix imagingVolumetric Specimen ImagerDecember 27, 2019
K193317cirdan imaging limitedCoreLite X-Ray Specimen CabinetDecember 13, 2019
K183624kub technologiesKubtec Mozart (Xpert42)June 20, 2019
K183142faxitron biopticsPathVisionXLMarch 14, 2019
K182727hologicTrident HD Specimen Radiography SystemJanuary 10, 2019
K173309faxitron biopticsFaxitron VisionCTMay 9, 2018
K170786faxitron biopticsFaxitron Bioptics Speciemen Radiography SystemJuly 18, 2017
K153583faxitron biopticsBioVision PlusApril 1, 2016
K122428faxitron biopticsFAXITRON SPECIEN RADIOGRAPHY SYSTEMSeptember 25, 2012
K111508hologicTRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001August 19, 2011
K091928bioptics10 X 10 VISIONJune 16, 2010
K091558biopticsBIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEMJuly 17, 2009