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510(k) Data Aggregation
K Number
K193637Device Name
MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System
Manufacturer
Compania Mexicana De Radiologia CGR, S.A. DE C.V.
Date Cleared
2020-01-28
(32 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
Compania Mexicana De Radiologia CGR, S.A. DE C.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. The MRH ALFA system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is designed to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the MRH ALFA radiographic system. The acquisition system comes as a separate system.
The MRH ALFA system is not intended for use in mammography, fluoroscopy or angiography. The MRH ALFA system is intended for adults and pediatric patients. The pediation is as follow:
- · Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.)
- · Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)
2. The MRH II system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is designed to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the MRH II radiographic system. The acquisition system comes as a separate system.
The MRH II system is not intended for use in mammography, fluoroscopy or angiography. The MRH II system is intended for adults and pediatric patients. The pediatric population is as follow:
- · Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.)
- · Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)
3. The MRH IIE system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is designed to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the MRH IIE radiographic system. The acquisition system comes as a separate system.
The MRH IIE system is not intended for use in mammography, fluoroscopy or angiography. The MRH IIE system is intended for adults and pediatric patients. The pediatric population is as follow:
- · Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.)
- · Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)
Device Description
The MRH ALFA, MRH II & MRH IIE Radiographic Systems designed and manufactured by CMR are general purpose, computed radiography (CR) X-ray systems used for diagnostic imaging (analog radiology) of adults and pediatric patients for taking 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. The devices are designed to meet the requirements of basic radiology procedures and produces a low radiation dose to the patient, while acquiring its images.
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K Number
K182134Device Name
ARiX RAD Radiographic System
Manufacturer
Compania Mexicana De Radiologia CGR, S.A. DE C.V.
Date Cleared
2018-11-26
(112 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
Compania Mexicana De Radiologia CGR, S.A. DE C.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ARIX RAD system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is design to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the ARIX RAD radiographic system. The acquisition system comes as a separate system.
The ARiX RAD system is not intended for use in mammography, fluoroscopy or angiography.
The ARiX RAD system is intended for adults and pediatric patients. The pediation is as follows:
- · Child (3-12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.)
- · Adolescent (12-21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)
Device Description
The ARiX RAD Radiographic System designed and manufactured by Compañía Mexicana de Radiología (CMR) is a general purpose, computed radiography (CR) X-ray system used for diagnostic imaging (analog radiology) of adults and pediatric patients for taking 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. The device is designed to meet the requirements of basic radiology procedures.
The ARIX RAD Radiographic system is capable of interfacing with AeroDR, PaxScan 4336W, Venu1717 detector in trigger mode. However, it is also capable of operating with external triggering devices providing the Hand-switch activation signals and the X-Ray Enable signal of the digital system as an external authorization for the X-Ray emission.
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K Number
K161518Device Name
PACS CORE/ENCORE
Manufacturer
COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V.
Date Cleared
2016-08-17
(76 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PACS CORE/ENCORE™ is a software device that receives digital images and data from various sources (such as, CT scanners, MR scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and/or across computer networks at distributed locations. Post-processing of the images can be performed using Multi Planar Reconstruction (MPR). Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using a monitor that meets technical specifications identified by FDA. Typical users of this system are trained professionals, physicians, nurses, and technicians.
Device Description
The PACS CORE/ENCORE™ system is a PACS workstation capable of receiving DICOM 3.1 medical images. The System allows displaying studies that are not in the same place where the system is placed. With its Web features, it is possible to review, modify, and approve studies located in a server. General features are as follows:
- Integration to PACS systems and inter-connectivity with DICOM stations.
- Performing queries to storage systems in other workstations and/or servers to retrieve DICOM studies or images.
- Image printing in Windows and DICOM printers.
- Selecting and ordering patient lists by date, study, name, gender or ID number.
- Importing and exporting images to DVD or CDROM in the following modes: DICOM DIR, DICOM files, JPEG or BMP.
- Importing NON-DICOM images to DICOM 3.0 format.
- Transfer of studies, images and reports via e-mail.
- Study Visualization by series.
- Cine feature.
- 3D reconstruction allowing: MPR (Multiplane Reconstruction) .
- Integrated report feature with transcription through pre-set templates, digital dictation, and voice recognition.
- Possibility to integrate with a Radiology Information System (RIS).
- Work list follow-up; dictated study, transcribed study, and authorized study.
- Due to its Web features, it is possible to review, change and approve studies remotely.
- Complete Web Windows Presentation Foundation (XBAP) technology application.
- Windows Presentation Foundation desk application.
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K Number
K123650Device Name
ARIX RAD ACQUISITION CONSOLE
Manufacturer
COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V.
Date Cleared
2013-02-20
(85 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ARiX RAD Acquisition Console™ software, used together with a digital X-ray detector is a digital X-ray image processing system designed for acquiring images and processing acquired images. The main features of the software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, optimizing window level and width of acquired images, rotating images, zooming images, measuring images and other features used for imaging processing. The ARiX RAD Acquisition Console™ system is compatible with the DICOM 3.x communications standard. It can transfer images processed in PACS and print images with a film printer compatible with DICOM 3.0 by using DICOM and network systems.
The ARIX RAD Acquisition Console™ system is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only and users must be qualified to create and diagnose radiological image data.
The main functions of the ARiX RAD Acquisition Console™ system are as follows:
a) Acquisition and storage of digital X-ray images from a digital X-ray Detector.
b) Input Study information (patient information, exam information).
c) Management of stored (archived) images.
d) Image processing for enhancement of archived images.
e) Review of stored images.
Editing of images.
g) DICOM conformance (e.g. DICOM Storage, DICOM Work list, DICOM Print, etc.)
h) For a DR system (X-ray machine and generator and Digital X-ray detector, etc.) or a need to interface with installed X-ray system, the:
Ability to configure X-ray exposure condition (kVp, mA, Sec etc) for various body . parts and positions.
Communication between Generator Console and ARIX RAD Acquisition Console™ . system.
Device Description
The ARiX RAD Acquisition Console™ is software used together with a digital . X-ray image acquisition system that uses a digital detector and a Compact GMX RAD X ray generator.
The system allows the user to acquire, review, process, and store high . resolution images, up to 43 cm x 35 cm (17 in x 13.8 in), at 2880 x 2400 pixel resolution and 14 bits depth.
The ARiX RAD Acquisition Console™ provides digital images in compliance . with the DICOM 3.0 standard.
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