Ziehm Imaging Inc

FDA Regulatory Profile

Summary

Total Recalls
14
510(k) Clearances
25
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1893-2017Class IIZiehm Imaging solo FD Mobile Fluoroscopic C-armFebruary 23, 2017
Z-2644-2016Class IIZiehm Vision2, Mobile C-arm for Mobile Fluoroscopic ImagingApril 15, 2016
Z-2642-2016Class IIZiehm Vision R, Mobile C-arm for Mobile Fluoroscopic ImagingApril 15, 2016
Z-2643-2016Class IIZiehm Solo, Mobile C-arm for Mobile Fluoroscopic ImagingApril 15, 2016
Z-2640-2016Class IIZiehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic ImagingApril 15, 2016
Z-2639-2016Class IIZiehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic ImagingApril 15, 2016
Z-2641-2016Class IIZiehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic ImagingApril 15, 2016
Z-0565-2014Class IIZiehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic ImagingNovember 21, 2013
Z-0563-2014Class IIZiehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic ImagingNovember 21, 2013
Z-0566-2014Class IIZiehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic ImagingNovember 21, 2013
Z-0562-2014Class IIZiehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic ImaginNovember 21, 2013
Z-0564-2014Class IIZiehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic ImagingNovember 21, 2013
Z-0567-2014Class IIZiehm Vision R C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic ImagingNovember 21, 2013
Z-0568-2014Class IIZiehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic ImagingNovember 21, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K243646Ziehm Solo FDMarch 17, 2025
K243735Ziehm Vision FDMarch 13, 2025
K243303Ziehm Vision RFD 3DJanuary 21, 2025
K243328Ziehm Vision RFDJanuary 15, 2025
K240099Ziehm Vision RFDFebruary 5, 2024
K240020Ziehm Vision FDJanuary 30, 2024
K234109Ziehm Solo FDJanuary 26, 2024
K231700Ziehm Vision FDDecember 15, 2023
K231669Ziehm Solo FDDecember 12, 2023
K231692Ziehm Vision RFDNovember 20, 2023
K231701Ziehm Vision RFD 3DJuly 10, 2023
K203428Ziehm Vision RFDMarch 17, 2021
K202360Ziehm Vision RFD 3DSeptember 16, 2020
K193230Ziehm Vision FDDecember 20, 2019
K190497Ziehm 8000November 20, 2019
K161976Ziehm Solo FDOctober 6, 2016
K142740Ziehm Vision RFD 3DApril 6, 2015
K132904ZIEHM VISION RFDDecember 5, 2013
K092438ZIEHM SOLODecember 23, 2009
K083545ZIEHM VISION RFDMay 15, 2009