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ZIEHM IMAGING INC

VISION · Radiology

510(k): 4 Recall: 9 UDI: 0 MAUDE: 1 Class.: 60

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510(k) Clearances (4)

ZIEHM VISION RFD
2009-05-15

Substantially Equivalent

ZIEHM VISION 2
2008-03-21

Substantially Equivalent

ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM
2006-07-07

Substantially Equivalent

ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM
2006-06-19

Substantially Equivalent

Recalls (9)

Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging
2016-04-15

Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.

Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging
2016-04-15

Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.

Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging
2016-04-15

Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.

Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging
2016-04-15

Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.

Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
2013-11-21

Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
2013-11-21

Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
2013-11-21

Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
2013-11-21

Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
2013-11-21

Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

MAUDE Adverse Events (1)

Malfunction
20150720

FDA Classification (60)

Processor, Cine Film

Radiology

Hydrogel Spacer

Radiology

Cassette, Measurement, Ardran-Crooks

Radiology

Assembly, Tube Housing, X-Ray, Therapeutic

Radiology

Generator, Orthovoltage, Therapeutic X-Ray

Radiology

Cabinet, X-Ray System

Radiology

Solid State X-Ray Imager (Flat Panel/Digital Imager)

Radiology

Camera, Multi Format, Radiological

Radiology

System, Imaging, Holography, Acoustic

Radiology

Film, Radiographic

Radiology

Counter, Whole Body, Nuclear

Radiology

Holder, Syringe, Lead

Radiology

Processor, Radiographic-Film, Automatic, Dental

Radiology

Camera, X-Ray, Fluorographic, Cine Or Spot

Radiology

System, Therapeutic, X-Ray

Radiology

Display, Diagnostic Radiology

Radiology

Radiation Therapy Marking Device

Radiology

Radiological Computer-Assisted Prioritization Software For Lesions

Radiology

System, Nuclear Magnetic Resonance Imaging

Radiology

Colon Computed Tomography System, Computer Aided Detection

Radiology

Instrument, Quality-Assurance, Radiologic

Radiology

Analyzer, Medical Image

Radiology

Dosimeter, Ionizing Radiation, Implanted

Radiology

Solid State Fluoroscopic X-Ray Imager

Radiology

Processor, Radiographic-Film, Automatic

Radiology

Test-Pattern, Radiographic

Radiology

Densitometer, Bone

Radiology

Image Management Software For Planning Of Otologic And Neurotologic Procedures

Radiology

Radiological Software Device To Predict Future Breast Cancer Risk

Radiology

Device, Beam Limiting, X-Ray, Diagnostic

Radiology

Prostate Immobilizer Rectal Balloon

Radiology

Device, Communications, Images, Ophthalmic

Radiology

System, X-Ray, Mammographic

Radiology

Chair, Pneumoencephalographic

Radiology

Phantom, Anthropomorphic, Radiographic

Radiology

Changer, Radiographic Film/Cassette

Radiology

System, Applicator, Radionuclide, Remote-Controlled

Radiology

Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

Radiology

Needle, Isotope, Gold, Titanium, Platinum

Radiology

Shield, Gonadal

Radiology

Source, Teletherapy, Radionuclide

Radiology

System, Image Processing, Radiological

Radiology

Arthrogram Tray

Radiology

Tube Mount, X-Ray, Diagnostic

Radiology

Device, Digital Image Storage, Radiological

Radiology

Post Breast Biopsy Hemostatic Breast Compression Device

Radiology

Collimator, Low Voltage, Therapeutic X-Ray

Radiology

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Radiology

Source, Isotope, Sealed, Gold, Titanium, Platinum

Radiology

Table, Radiologic

Radiology

System, Applicator, Radionuclide, Manual

Radiology

Programmer, Changer, Film/Cassette, Radiographic

Radiology

Radiological Computer Assisted Detection/Diagnosis Software For Fracture

Radiology

Holder, Radiographic Cassette, Wall-Mounted

Radiology

Radiographic Contrast Tray

Radiology

System, X-Ray, Fluoroscopic, Image-Intensified

Radiology

Automated Radiological Image Processing Software

Radiology

System, Imaging, X-Ray, Electrostatic

Radiology

Coil, Magnetic Resonance, Specialty

Radiology

Device, Spot-Film

Radiology