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Found 7 results
510(k) Data Aggregation
K Number
K100102Device Name
CS-SERIES-FP
Manufacturer
OMEGA MEDICAL IMAGING, INC.
Date Cleared
2010-08-31
(230 days)
Product Code
OWB, JAA, MQB
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
OMEGA MEDICAL IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Omega Medical Imaging, Inc. CS-series-FP (SSXI) systems are intended for use in radiographic/fluoroscopic application including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
Device Description
The Omega Medical Imaging, Inc. CS-series-FP (SSXI) systems incorporates a solid-state flat-panel detector (FPD) as an option to the cleared Omega Medical Imaging, Inc. CS-series fluoroscopy systems (K070834) in lieu of an image intensifier/CCD based imaging detector. The CS-series fluoroscopy single and dual plane x-ray imaging systems are configured with a floor mounted C-am and a patient table. The dual plane systems incorporate a ceiling suspended C-arm. The image detector utilizes a cesium iodide scintillator coupled to an amorphous silicon TFT panel. The caplured digital image is processed by the acquisition system which includes image processing, viewing functions, local storage, and DICOM compatibility.
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K Number
K093572Device Name
R650 QDASM COLLIMATOR
Manufacturer
OMEGA MEDICAL IMAGING, INC.
Date Cleared
2010-02-03
(77 days)
Product Code
IZW
Regulation Number
892.1610Why did this record match?
Applicant Name (Manufacturer) :
OMEGA MEDICAL IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Omega R650 QDASM automatic beam limiting device is intended for use in X-ray diagnostic radiographic/fluoroscopic applications.
Device Description
The Omega R 650 QDASM is an automatic beam limiting device designed for use in diagnostic radiographic/fluoroscopic applications. It includes square field shutters, spectral filters, and an additional lung filter for cardiac application. This device is substantially equivalent to the predicate devices with respect to technological characteristics.
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K Number
K070834Device Name
CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS)
Manufacturer
OMEGA MEDICAL IMAGING, INC.
Date Cleared
2007-05-18
(52 days)
Product Code
OWB, JAA
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
OMEGA MEDICAL IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Omega Medical Imaging, Inc. CS-Series systems are intended for use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
Device Description
The Omega Medical Imaging, Inc. CS-Series systems are comprised of an x-ray source/image receptor positioning device in a permanently floor mounted C-Arm configuration with options of either an elevating only or elevating/tilt patient table. The system may also be configure with a ceiling suspended "C" for bi-plane operation. The positioning of the source/receptor is achieved by motorized motions controlled by the operator. The imaging is achieved by way of an image intensifier/CCD camera with digital image processing.
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K Number
K062647Device Name
E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50
Manufacturer
OMEGA MEDICAL IMAGING, INC.
Date Cleared
2006-10-20
(44 days)
Product Code
OWB
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
OMEGA MEDICAL IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Omega Medical Imaging, Inc. e-VIEW systems are intended for use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
Device Description
The Omega Medical Imaging, Inc. e-VIEW systems are comprised of an x-ray source/image receptor positioning device in a permanently floor mounted C-Arm configuration. The positioning of the source/receptor is schieved by motorized motions controlled by the operator. The patient table can be configured with different motorized motions including elevating, Trendelenburg and vertical tilt, lateral and longitudinal table top travel, and lateral table top tilt. The imaging is achieved by way of an image intensifier/CCD camera with digitty in nage processing.
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K Number
K050092Device Name
R605 FACS COLLIMETER
Manufacturer
OMEGA MEDICAL IMAGING, INC.
Date Cleared
2005-01-31
(17 days)
Product Code
IZW
Regulation Number
892.1610Why did this record match?
Applicant Name (Manufacturer) :
OMEGA MEDICAL IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Omega R605 FACS automatic collimator is intended for use in diagnostic radiographic/fluoroscopic applications.
Device Description
The Omega R 605FACS is an automatic collimator designed for use in diagnostic Trie Offically of tool AOO is an adtomatio continues round field shutters and an additional lung filter for cardiac application.
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K Number
K990055Device Name
B-400 CEILING MOUNTED POSSITIONER, MODEL B-400
Manufacturer
OMEGA MEDICAL IMAGING, INC.
Date Cleared
1999-02-02
(26 days)
Product Code
JAA
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
OMEGA MEDICAL IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To support the Diagnostic Source Assembly & Image Receptor used in performing general-purpose diagnostic fluoroscopic procedures.
Device Description
The B-400 Ceiling Mounted C-Positioner is a device intended to hold an X-Ray tube and an image intensifier 180° apart in a "C" configuration for the purpose of verforming general purpose diagnostic fluoroscopic procedures. The C-Positioner allows variable positioning of the X-Ray tube/Image Intensifier from +145 degrees Left Anterior Oblique (LAO) to 55 degrees Left Posterior Oblique (LPO). The device will maintain isocenter throughout its full range of motorized movement. The entire assembly is mounted to a set of ceiling rails.
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K Number
K970947Device Name
B-350 CEILING MOUNTED C-POSITIONER
Manufacturer
OMEGA MEDICAL IMAGING, INC.
Date Cleared
1997-05-14
(61 days)
Product Code
JAA
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
OMEGA MEDICAL IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To support the Diagnostic Source Assembly & the Image Receptor used in performing general purpose diagnostic fluoroscopic procedures.
Device Description
The B-350 Ceiling Mounted C-Positioner is a device intended to hold an X-Ray tube and an image intensifier 180° apart in a "C" configuration for the purpose of performing general purpose diagnostic fluoroscopic procedures.
The C-Positioner allows variable positioning of the X-Ray tube/Image Intensifier from 30 degrees Left Anterior Oblique (LAO) to 120 degrees Left Posterior Oblique (LPO). The device will maintain isocenter throughout its full range of motorized movement. The entire assembly is mounted to a set of ceiling rails with a detent provided to lock the unit into place for use in creating a common isocenter between the Anterior/Posterior (A/P) and lateral planes. A microswitch controlled interlock system independently prevents X-Ray exposure anywhere outside the detent position.
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