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510(k) Data Aggregation
K Number
K092438Device Name
ZIEHM SOLO
Manufacturer
ZIEHM IMAGING, INC.
Date Cleared
2009-12-23
(138 days)
Product Code
OWB, JAA, OXO
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
ZIEHM IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ziehm Solo is intended to provide contactless fluoroscopy Imaging, capturing, temporarily storing, and display of non-invasive x-ray imaging of the patient using pulsed and continuous fluoroscopy, during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room fluoroscopy procedures. Radiographic film examinations can be made with an accessory cassette device when attached to the Image Intensifier. This device does not support and is not intended for use in performing mammographic imaging.
Device Description
The Ziehm Solo Mobile Stand incorporates a single arm monitor assembly providing a more adaptable positioning of the display monintors to the clinician and the C-arm in relation to the patient. The C-profile provides fixed distance mounting of the generator and Image Intensifier and manual rotation around a non iso-centric location. The mobile stand allows the manual rotational and linear movements of the C-arm with a motorized vertical movement for positioning the c-arm at various angles and distances for visualization of patient's anatomical structures. Optional 120kV and or 20mA Fluoro operations are available. The 2.02 kW high frequency generator incorporates a single focus fixed anode x-ray tube, and high voltage generator is a single mono-block generator tube housing assembly. The virtual collimator and x-ray control mount to the generator housing assemble and provides pulsed and continuous fluoroscopy operations including a special digital radiography (snapshot) mode. The SoloCenter is a centralized touch screen providing the user/operator with a graphical user Interface including the x-ray control panel. The Ziehm Solo does not have a conventional Monitor Cart, the workstation consists of a mechanical arm assembly supporting a single or dual high-resolution flat panel LCD display monitor(s). Ceiling or wall monitors can be added by means of two external monitor connectors. Other conventional external interfaces are provided on the mobile stand for preipherial devices such as video printers, and storage devices such as USB and DVD.
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K Number
K083545Device Name
ZIEHM VISION RFD
Manufacturer
ZIEHM IMAGING, INC.
Date Cleared
2009-05-15
(168 days)
Product Code
OWB, JAA, MOB
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
ZIEHM IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ZIEHM VISION RFD is intended for use in providing medical imaging, using pulsed and continuous fluoroscopic digital imuging, as well as digital subtraction and cine image capture during diagnostic interventional, and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required, such procedures may included but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional electrophysiology, angiography, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for computer aided surgery procedures and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required in and around high magnetic ficids. The visualization of such unatomical structures assists the clinician in the clinical outcome. At the discretion of a physician the device may be used for other imaging applications.
This device does not support direct radiographic film exposures and is not intended for use in performing mammography.
Device Description
The ZIEIIM VISION RFD Mobile Stand incorporates a small compact design making the positioning of the c-arm in relation to the patient easier for the operator. The C-profile provides fixed distance mounting of the generator and Flat-panel Detector (SSXI) and manual rotation around a non iso-centric location. The mobile stand allows manual rotational and linear movements with a motorized vertical movement for positioning the c-arm at various angles and distances for visualization of pation's anatomical structures. The high frequency generator with dual focus rotating anode x-ray lube, advanced active cooling, x-ray control, are assembled in one housing in a single mono-block generator tube housing assembly, with the virtual collimator mounting to the housing assemble. The Zichm Vision RFD can have one of the following two generators 7.5 kW or optional 20 kW. They both provide pulsed and continuous fluoroscopy operations including a special digital radiography (snapshot) mode. The VisionCenter is a ccuralized touch screen panel providing the uscr/operator with a clear graphicul user Interface including the xray control panel. The ZIEHM VISION RFD Monitor Cart workstation consists of a mechanical cart assembly, supporting dual high-resolution flat panel LCD display monitors and interfaces are provided for preinherial devices such as external monitors, video printers, injectors and storage devices (USB, DVD).
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K Number
K073346Device Name
ZIEHM VISION 2
Manufacturer
ZIEHM IMAGING, INC.
Date Cleared
2008-03-21
(113 days)
Product Code
JAK, AND, JAA, OWB
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
ZIEHM IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ZIEHM VISION product Family is intended to provide pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures and procedures such as, vascular, cardiac, anglographic, cholangiography, endoscopic, urologic, orthopedic, neurological, critical cate, and emergency room procedures. Radiographic film examinations can be made with an accessory cassette device when attached to the Image Intensifier. At the discretion of a physician the device may be used for other imaging applications.
ZIEHM VISION with option VARIO is intended to provide pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intented for use in visualizing complex anatomical structures and procedures such as, vascular, cardiac, anglographic, cholangiography, endoscopic, urologic, orthopedic, neurological, critical care, and emergency room procedures and whenever the clinician benefits from variable Iso-centric positioning. Radiographic film examinations of a pharising than accessory cassette device when attached to the Image Intensifier. At the discretion of a physician the device may be used for other intaging applications.
ZIEHM VISION " with option FD is intended to provide pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in isualizing complex anatomical structures and procedures such as, vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurological, critical care, and emergency room procedures and where higher accuracy in image geometry is required in and around high magnetic fields. At the discretion of a physician the device may be used for other imaging applications.
ZIEHM VISION with option 3D is intended to provide pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures and procedures such as, vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurological, critical care, and emorgency room procedures and Whenever the clinician benefits from variable Iso-centric positioning and/or intraoperatively generated 3D imaging of high contrast objects (bones and joints), complex anatomical structures such as cervical, thoracic, and lumber regions of the spines and joint fractures of the upper and lower extremities, and where digital image and c-arm positioning data is required for computer aided surgery procedures. Radiographic film examinations can be made with an accessory cassete device when attached to the Image Intensifier. At the discretion of a physician the device may be used for other imaging applications.
Device Description
The ZIEHM VISION product Family is a mobile C-am x-ray system intended for fluoroscopic imaging and is a modified version of our present ZIEHM VISION digital mobile c-arm K011292. The modified ZIEHM VISION incorporates additional new innovative technologies from two of our other legally marketed devices Ziehm Vision FD, and Ziehm Vario 3D. The base system includes highvoltage x-ray generator, and control, x-ray tube, image intensifier, touch control user interface and monitor cart/workstation with line power matching, Vision II 2D video image of seem with display, CAN bus control system, and internal and external image storage capabilities. The device includes, functional options such as Endoscopic monitor display interface, 3D imaging, NaviPort digital image exchange interface, SSXI/Flat Panel Detector, and Vario Iso-centric operation. There optigns will be identified by extensions to the product name ZIEHM VISION as Vario, FD, 3D, FD, 3D,
The ZIEHM VISION 2 product includes high-voltage x-ray generator and control, x-ray tube, image intensifier, and monitor cart/workstation with 2D image display and optional 3D digital image processing. Device provides internal and external image storage capability, and supports conventional spot-film capability with the Image intensifier option only. Optional monitor cart/workstation with NaviPort digital image exchange interface for Surgical Navigation Devices. Optional SSXI solid sate Varia ISO Contrio model in the imaging of critical anatomical structures. Optional Vario ISO-Centric mechanics work with the 3D maging or stand alone as a method for track anatomical structures in both LAT and AP projections.
The ZIEHM VISION has two main units, Mobile Stand and Monitor Cart workstation.
The Mobile Stand C-arm consists of a High frequency generator and x-ray tube assembly with active VicionCantor uses to collination assembly, 9" or 12" image intensifier (image receptor), VisionCenter user touch control interface, and CCD camera, mechanical C-Profile supporting the generator, image receptor and integrated laser light localizers. The c-profile in conjunction with the other mechanics of the mobile stand allow manual rotational, linear and vertical movements for positioning the c-arm at various and distances for visualization of patient's anatomical structures.
Mobile stand optional functionality includes, VARIO ISO-Centric motorized movement, VARIO-3D recepted in available as a voluning for 3D imaging and Flat Panel Detector/SSXI (Image receptor) is available as a replacement for the trailer beechords on the mobile stand
Monitor Cart workstation consists of a mechanical assembly supporting dual flat panel LCD display monitors, line matching power supply, and Vision II digital image memory device. Optional functionality includes VisionCenter touch control, Vario 3D control and image processing, Ziehm NAVI PORT digital image exchange interface, Endoscopic monitor displays, external image storage and video connection for attachment of external monitor displays
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K Number
K061310Device Name
ZIEHM VARIO 3D DIGITAL MOBILE IMAGING SYSTEM
Manufacturer
ZIEHM IMAGING, INC.
Date Cleared
2006-07-07
(58 days)
Product Code
JAK, JAA
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
ZIEHM IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ZIEHM VARIO and ZIEHM VARIO 3-D C-arms provide fluoroscopic and spot film imaging of the patient during diagnostic, Interventional and surgical procedures. It is intended to be used whenever the Clinician benefits from Iso-centric positioning and/or intraoperatively generated 3D imaging of high contrast objects (bones and joints), complex anatomical structures such as cervical, thoracic, and lumber regions of the spine and joint fractures of the upper and lower extremities. The design includes features intended for performing vascular, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, and critical care and emergency room procedures. At the discretion of a physician the device may be used for other imaging applications. Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier.
Device Description
The ZIEHM VARIO 3D has two main units; Mobile Stand and Monitor Cart workstation. The Mobile Stand C-arm consists of a high frequency generator, x-ray tube assembly, image intensifier, and user. touch control interface, C-Profile supporting the generator and image intensifier and Integrated Laser light localizers in the image receptor. The Mobile Stand C-profile provides fixed distance mounting of the generator and image receptor allowing the user rotational and linear movements for positioning the c-arm at various angles and distances for visualization of patient's anatomical structures in addition the device has variable ISO Centric operation, and integrated Iso-centric operations for performing 3D imaging. The monitor cart workstation supports dual flat panel LCD display monitors, digital image memory device, imaging capture, image processing, and touch control user interface. External Video connection is provided with RS-170 video timing for domestic market, CCIR for International markets. The ZIEHM VARIO 3D also provides optional peripheral connections for such devices as video printers, DICOM 3, CAS connection for image guided surgery and external media storage devices.
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K Number
K061534Device Name
ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM
Manufacturer
ZIEHM IMAGING, INC.
Date Cleared
2006-07-07
(35 days)
Product Code
OWB
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
ZIEHM IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ziehm Vision FD is intended to provide pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. Is intended for use in visualizing complex anatomical structures and procedures such as, vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, critical care, emergency room procedures, and where higher accuracy in image geometry is required. At the discretion of a physician the device may be used for other imaging applications.
Device Description
The ZIEHM VISION FD has two main units; Mobile Stand and Monitor Cart workstation. The Mobile Stand C-arm consists of a high frequency generator, X-ray Tube assembly, Solid State X-Ray Imager / Flat Panel Detector, user touch control interface, C-Profile supporting the generator and Solid State X-ray Imager (SSXI), and Integrated Laser light localizers in the image receptor. The Mobile Stand C-profile provides fixed distance mounting of the generator and image receptor allowing the user rotational and linear movements for positioning the c-arm at various angles and distances for visualization of patient's anatomical structures.
The monitor cart workstation supports dual flat panel LCD display monitors, Vision II digital image memory device, imaging capture, image processing, and VisionCenter touch control user interface. External Video connection is provided with RS-170 video timing for domestic market, CCIR for International markets. The Vision FD also provides optional peripheral connections for such devices as video printers, DICOM 3 and external media storage devices.
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K Number
K061203Device Name
ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM
Manufacturer
ZIEHM IMAGING, INC.
Date Cleared
2006-06-19
(49 days)
Product Code
OWB, JAA, OXO
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
ZIEHM IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ziehm Vision R is designed to provide pulsed and continuous fluoroscopic imaging, and spot film imaging of the patient during diagnostic, Interventional and surgical procedures. The design includes features for diagnostic and interventional cardiac imaging procedures, and is also intended for use in visualizing complex anatomical structures and procedures for vascular, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, and critical care and emergency room procedures. At the physician's discretion the device may be used for other imaging applications.
Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier.
Device Description
The Ziehm Vision R has two mobile units: a mobile C-arm stand and a monitor cart/ workstation. The C-arm stand contains the x-ray control, high voltage generator, VisionCenter touch controlusion interface, power subs-systems, and control system. The "C profile" or C-shaped mechanical assembly supports at one end the image intensifier and the other the high voltage generator and lubes hassion assembly. The C-Profile is designed to perform rotational and linear movements that allow the user to position the imaging components at various angles and distances with respect to the prieve
The monitor cart/workstation supports dual flat panel LCD display monitors, integrated Ziehm Vision digital image system, imaging capture, image processing, DICOM 3, and VisionCenter touch vontol user interface. External Video connection is provided with RS-170 video timing for domestic market, CCIR for International markets.
The Ziehm Vision R also provides optional peripheral connections for such devices as video printers, thermal printers, network connections, DICOM 3, and external media storage such as USB, DVD devices. A single auxiliary connection is provided for connection to angiographic injoctor systems with the aim of synchronizing image acquisition of angiographic images during controst media injections.
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K Number
K051064Device Name
ZIEHM QUANTUM
Manufacturer
ZIEHM IMAGING, INC.
Date Cleared
2005-05-26
(30 days)
Product Code
OWB, JAA, OXO
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
ZIEHM IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ZIEHM QUANTUM series Mobile C-Arm is intended for use in both Radiographic and Fluoroscopic applications. It is suitable for a wide variety of surgical intervention or guidance procedures requiring X-ray imaging - both inside and outside the operating room. These procedures include Cerebral, Thoracic, Vascular, Biliary, Abdominal, Orthopaedic, Peripheral, Embolization, Stent Placement, Urological Special Vascular-I flow Procedures, and other related fluoroscopic examinations requiring interventional procedures.
The ZIEHM QUANTUM Mobile C-arms are also suitable as a back up for fixed-based X-ray Vascular and Intervention Procedures.
Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier.
Device Description
ZIEHM QUANTUM (Mobile x-ray system)
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