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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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-3DV
In Commercial Distribution

  • B193IG10H3DV0 ()
SXCH-SYS-5437-3DV

  • 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-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
The AquariusAPS server is a stand-alone medical device software which performs various kinds of data processing on incoming DICOM data sets, according to user pre-configured rules and schedules.
Terarecon Inc.
AquariusAPS
In Commercial Distribution

  • AQAPS1 ()


  • Radiological PACS software
No Description
Fivos, Inc.
Medstreaming
Not in Commercial Distribution

  • B159MEDSTREAMINGPACS0 ()


  • Radiological PACS software
No Description
Fivos, Inc.
5
Not in Commercial Distribution

  • B159FIVOSPACS0 ()


  • Radiological PACS software
OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded into it. This enables the surgeon to gather measurements and angles of anatomical landmarks, visualize the effect of the surgery by animating regions of the image, size and position templates representing prosthetic or fixation devices and output reports specifying the measurements and device decisions.
MERIDIAN TECHNIQUE LIMITED
7.3
In Commercial Distribution

  • B02173WEBIPX0 ()


  • Radiological PACS software
Radiation therapy QA device.
SUN NUCLEAR CORP.
12170000
In Commercial Distribution

  • B016121700000 ()
12170000

  • Radiation therapy software
Radiation therapy QA device.
SUN NUCLEAR CORP.
12160000
In Commercial Distribution

  • B016121600000 ()
12160000

  • Radiation therapy software
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