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ImageGrid Radiology Viewer System is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations.
Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
CANDELIS, INC.
IG-10H
In Commercial Distribution
- B193IG10H0 ()
- Radiological PACS software
ImageGrid Radiology Viewer System is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations.
Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
CANDELIS, INC.
IG-10B-DR
In Commercial Distribution
- B193IG10BDR0 ()
- Radiological PACS software
ImageGrid Radiology Viewer System is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations.
Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
CANDELIS, INC.
IG-10B
In Commercial Distribution
- B193IG10B0 ()
- Radiological PACS software
No Description
ADVANCED INSTRUMENTATIONS, INC.
PM-Max15
In Commercial Distribution
- B510PMMAX15 ()
- Multiple vital physiological parameter monitoring system, clinical
No Description
ADVANCED INSTRUMENTATIONS, INC.
PM-Max13
In Commercial Distribution
- B510PMMAX13 ()
- Multiple vital physiological parameter monitoring system, clinical
"The SOPIX series digital X-ray imaging systems are intended to be used by a dental practitioner. The sensor (located in the patient’s
mouth just like a silver fi lm) captures the X-rays produced by the generator. Then it transmits this data to the computer to display
the X-ray image on the screen.
All the images captured with the SOPIX series system can be recalled onto the screen with the Sopro Imaging software provided with
the system. This software manages the display, processing and storage of images taken with the SOPIX series system.
A.C.E™ (Automatic Control Exposure) technology, patented by SOPRO, provides the system with outstanding features. In real time
it analyses the quantity of energy received by the sensor, which fi xes the image acquisition once it has received the energy needed
to produce a good-quality image. As a result, every image is protected against overexposure."
SOPRO
CAPT SOPIX² T2 USB2 CONDO
In Commercial Distribution
- M430S80200051 ()
S_802_0005
- Dental digital imaging sensor, intraoral
The Sonoclot Coagulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and platelet function. This system has two configurations. The historic configuration is a Sonoclot Analyzer connected to a thermal graphics printer. The standard configuration is a Sonoclot Analyzer connected to a computer running Sonoclot Viewer data collection software.
The Sonoclot Analyzer System rapidly provides information on the entire hemostasis process including coagulation, fibrin gel formation, clot retraction (platelet function) and fibrinolysis. The Sonoclot Analyzer System generates a qualitative graph, known as the Sonoclot Signature, and quantitative results on the clot formation time (Activated Clotting Time-Onset), the rate of fibrin polymerization (Clot Rate), and clot retraction (Platelet Function). This information can be used to identify numerous coagulopathies including platelet dysfunction, factor deficiencies, anticoagulant effect, hypercoagulable tendencies and hyperfibrinolysis. Different disposable tests are available for use with the Sonoclot Analyzer System for different applications.
SIENCO, INC.
DP-2951
In Commercial Distribution
- B558DP29510 ()
- Coagulation analyser IVD, point-of-care, line-powered
Parascript® AccuDetect® is a Computer-Aided Detection (CAD) software device intended to aid radiologists reading mammograms. It is a proprietary software application designed to process FFDM images. The digital mammography images are automatically analyzed to identify areas suspicious for possible soft tissue densities and/or calcifications. Results are displayed on a computer monitor for review by a radiologist. The radiologist is instructed to first review each case in the conventional manner and then re-examine the case utilizing the information supplied by the Parascript® AccuDetect system before making a final assessment for the case.
AccuDetect® is not a diagnostic device, as the CAD marks are intended to be used to assist only in detection and not in interpretation. Therefore, AccuDetect® can assist a radiologist in detecting areas of concern that would have been missed without its use, but if used properly it cannot cause a radiologist to miss areas of concern that would have been detected without AccuDetect®.
PARASCRIPT, LLC
7.0
In Commercial Distribution
- M760ACCFFDM00170 ()
ACCFFDM00170
- Radiology DICOM image processing application software
Parascript® AccuDetect® is a Computer-Aided Detection (CAD) software device intended to aid radiologists reading mammograms. It is a proprietary software application designed to process FFDM images. The digital mammography images are automatically analyzed to identify areas suspicious for possible soft tissue densities and/or calcifications. Results are displayed on a computer monitor for review by a radiologist. The radiologist is instructed to first review each case in the conventional manner and then re-examine the case utilizing the information supplied by the Parascript® AccuDetect system before making a final assessment for the case.
AccuDetect® is not a diagnostic device, as the CAD marks are intended to be used to assist only in detection and not in interpretation. Therefore, AccuDetect® can assist a radiologist in detecting areas of concern that would have been missed without its use, but if used properly it cannot cause a radiologist to miss areas of concern that would have been detected without AccuDetect®.
PARASCRIPT, LLC
6.1
In Commercial Distribution
- M760ACCFFDM00161 ()
ACCFFDM00161
- Radiology DICOM image processing application software
CINA-ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data.
The Software automatically reorients images, segments and analyzes ASPECTS Regions of lnterest (ROIs). CINA-ASPECTS extracts image data for the ROI(s) to provide analysis and computer analytics based on morphological characteristics. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECT (Alberta Stroke Program Early CT) Score. CINA-ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup with known MCA or ICA occlusion, for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score. This device provides information that may be useful in the characterization of early ischemic (acute) brain tissue injury during image interpretation. CINA-ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment using the ASPECTS region definitions and highlighting ROIs and numerical scoring
AVICENNA.AI
1.5
In Commercial Distribution
- B826CINAASPECTS150 ()
- Radiology DICOM image processing application software