ClearanceBrief
Company ยท DE

Ziehm Imaging GmbH

FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2025. Name variants (Inc, Corp, punctuation) are merged.

25510(k) clearances (0 in 12 months)
15recalls (0 in 12 months)
14recalls that name a 510(k)

Product codes

CodeDeviceRecords
OWBInterventional Fluoroscopic X-Ray System33
JAASystem, X-Ray, Fluoroscopic, Image-Intensified5
JAKSystem, X-Ray, Tomography, Computed2

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Mar 17, 2025K243646Ziehm Solo FD
Ziehm Imaging GmbH, DE
OWB
Mar 13, 2025K243735Ziehm Vision FD
Ziehm Imaging GmbH, DE
OWB
Jan 21, 2025K243303Ziehm Vision RFD 3D
Ziehm Imaging GmbH, DE
OWB
Jan 15, 2025K243328Ziehm Vision RFD
Ziehm Imaging GmbH, DE
OWB
Feb 5, 2024K240099Ziehm Vision RFD
Ziehm Imaging GmbH, DE
OWB
Jan 30, 2024K240020Ziehm Vision FD
Ziehm Imaging GmbH, DE
OWB
Jan 26, 2024K234109Ziehm Solo FD
Ziehm Imaging GmbH, DE
OWB
Dec 15, 2023K231700Ziehm Vision FD
Ziehm Imaging GmbH, DE
OWB
Dec 12, 2023K231669Ziehm Solo FD
Ziehm Imaging GmbH, DE
OWB
Nov 20, 2023K231692Ziehm Vision RFD
Ziehm Imaging GmbH, DE
OWB
Jul 10, 2023K231701Ziehm Vision RFD 3D
Ziehm Imaging GmbH, DE
OWB
Mar 17, 2021K203428Ziehm Vision RFD
Ziehm Imaging GmbH, DE
JAA
Sep 16, 2020K202360Ziehm Vision RFD 3D
Ziehm Imaging GmbH, DE
OWB
Dec 20, 2019K193230Ziehm Vision FD
Ziehm Imaging GmbH, DE
OWB
Nov 20, 2019K190497Ziehm 8000
Ziehm Imaging GmbH, DE
OWB
Oct 6, 2016K161976Ziehm Solo FD
Ziehm Imaging GmbH, DE
OWB
Apr 6, 2015K142740Ziehm Vision RFD 3D
Ziehm Imaging GmbH, DE
OWB
Dec 5, 2013K132904ZIEHM VISION RFD
Ziehm Imaging GmbH
JAA
Dec 23, 2009K092438ZIEHM SOLO
Ziehm Imaging, Inc.
OWB
May 15, 2009K083545ZIEHM VISION RFD
Ziehm Imaging, Inc.
OWB
Mar 21, 2008K073346ZIEHM VISION 2
Ziehm Imaging, Inc.
JAK
Jul 7, 2006K061534ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM
Ziehm Imaging, Inc.
OWB
Jul 7, 2006K061310ZIEHM VARIO 3D DIGITAL MOBILE IMAGING SYSTEM
Ziehm Imaging, Inc.
JAK
Jun 19, 2006K061203ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM
Ziehm Imaging, Inc.
OWB
May 26, 2005K051064ZIEHM QUANTUM
Ziehm Imaging, Inc.
OWB

Latest recalls

DateFirm and productCodeLinked 510(k)
Feb 23, 2017Ziehm Imaging Inc
Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
Terminated		 OWBK161976
Apr 15, 2016Ziehm Imaging Inc
Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging
Terminated		 JAAK073346
Apr 15, 2016Ziehm Imaging Inc
Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging
Terminated		 OWBK092438
Apr 15, 2016Ziehm Imaging Inc
Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging
Terminated		 OWBK061203
Apr 15, 2016Ziehm Imaging Inc
Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging
Terminated		 OWBK083545
Apr 15, 2016Ziehm Imaging Inc
Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging
Terminated		 JAAK132904
Apr 15, 2016Ziehm Imaging Inc
Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging
Terminated		 OWBK142740
Dec 24, 2013Ziehm Imaging Inc
Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Terminated		 OWBK083545
Dec 24, 2013Ziehm Imaging Inc
Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Terminated		 OWBK061203
Dec 24, 2013Ziehm Imaging Inc
Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Terminated		 OWBNone listed
Dec 24, 2013Ziehm Imaging Inc
Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Terminated		 OWBK073346
Dec 24, 2013Ziehm Imaging Inc
Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Terminated		 OWBK073346
Dec 24, 2013Ziehm Imaging Inc
Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Terminated		 OWBK092438
Dec 24, 2013Ziehm Imaging Inc
Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Terminated		 OWBK851031
Apr 16, 2012Ziehm Imaging Inc
Double foot switch, type KF 2 1S/1 S-MED-AP, manufactured by the company Seute Schaltgerate. GmbH & Co. KG for Ziehm Imaging GmbH Germany, and used with Ziehm Imaging GmbH Mobile C-arm as a component
Terminated		 JAAK061203
K073346 +2
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