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510(k) Data Aggregation
K Number
K100001Device Name
MOBIVISION
Manufacturer
ALMANA MEDICAL IMAGING
Date Cleared
2010-06-25
(172 days)
Product Code
MQB, IZL
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
ALMANA MEDICAL IMAGING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone supine position. Not for mammographic use.
Device Description
Not Found
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K Number
K082064Device Name
RADVISION ET DIAGNOSTIC X-RAY SYSTEM
Manufacturer
ALMANA MEDICAL IMAGING
Date Cleared
2008-08-22
(32 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
ALMANA MEDICAL IMAGING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This radiographic system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Device Description
This diagnostic x-ray system consists of a tubehead/collimator assembly mounted on a ceiling suspension along with a generator, generator control, and an elevating x-ray table. Power ratings for the available generators are in the rage of 32 kw to 80 kW. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV with current of 300 -100 mA. Exposure time is 1 ms - 10 s.
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K Number
K080847Device Name
RFVISION, MODEL 9.9D
Manufacturer
ALMANA MEDICAL IMAGING
Date Cleared
2008-08-06
(133 days)
Product Code
OWB
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
ALMANA MEDICAL IMAGING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RFVision 9.9D is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications when general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed. The RFVision 9.9D allows the operator to view and enhance digital fluoroscopic images. High resolution digital spot images may be acquired at single or rapid acquisition rates. Images may be viewed and enhanced enabling the operator to bring out diagnostic details.
Device Description
RFVision 9.9 D is an advanced remote controlled 90/90 Digital RF system with floating table top for radiographic and fluoroscopy procedures. Reliable, time tested generator. High quality image intensifier and digital imaging system improves diagnostic capabilities assures filmless operations and smooth integration in digital PACS environment.
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K Number
K080614Device Name
DR VISION NEO, DR VISION DOU
Manufacturer
ALMANA MEDICAL IMAGING
Date Cleared
2008-06-20
(107 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
ALMANA MEDICAL IMAGING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These are Radiographic X-Ray Systems with a flat panel detector(s), which allow the acquisition of x-ray exposures without the use of conventional film/screen systems. The systems allow radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying positions.
Device Description
DR Vision Neo is flat panel state-of-art digital imaging suite, driving significant improvements in productivity and quality. The streamlined efficiency of the DR Vision Neo enhance the entire radiographic operation, improving workflow by delivering diagnostic images instantly, and allowing users to move x-ray images clectronically to remote workstations, image archives, and printers. The DR Vision Neo is a Trixell Pixium 4600 flat panel detector based direct digital radiography system with ceiling suspended design. These are essentially standard diagnostic x-ray systems which have added to them a digital x-ray acquisition panel. The DR Vision Neo has a single panel while the DR Vision Duo has two panels, one in a wall stand and one in the patient table. Features are:
* Flat panel detector: Amorphous silicon panel with cesium iodide scintillator offers exceptional DQE 17" x 17" size eliminates the need to rotate the panel for transverse views l 43 x 143 micron pixels in matrix of 3121 x 3121 x 14 bits. * High-precision 9 million pixel resolution. * 14-bit digital data conversion with 16.000 grayscales. * Motorized detector panel movements with auto-tracking with ceiling suspended tube stand. Battery operated mobile elevating table for radiological applications with 4-way floating table top allows easy and quick patient positioning. * IHE/HL-7/DICOM Standard
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K Number
K072659Device Name
RAD VISION, MODELS E AND EU
Manufacturer
ALMANA MEDICAL IMAGING
Date Cleared
2007-11-15
(56 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
ALMANA MEDICAL IMAGING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position..
Device Description
The Rad Vision E is a standard configuration fixed column diagnostic radiographic system. The column can move right or left on a track and the tube head can move up and down. Rad Vision eu is a universal swivel arm X-ray system. It is easy to operate and permits a swift radiographic procedure, a feature which applies to all conventional exposure techniques on all parts of the body. The system is composed of a floor-to-wall column and a turnable arm. On the arm is the tubehead with a collimator mounted to it. All components required for a complete system are supplied. With the patient table, the patient can be moved into any required position without the need for repositioning. Therefore it offers the same advantages as a bucky radiography table. Owing to the large vertical movement of the swivel arm patients in the standing position can be examined from head to feet.
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