A DICOM viewer for diagnostic use is most probably a PACS in class II and subject to 510k http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=892.2050
A simple viewer used to review original images could be a medical image storage device http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=892.2010 or medical image communication device http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=892.2020, depending on it context of use. But even a simple viewer, which intended use claims primary diagnosis, is most probably a class II PACS.
Likewise, as soon as software has features like MIP/MPR/ 3D, etc, odds are high that it is a PACS class II device. Hence these features are used for image interpretation.
I wonder what rationale used your competitor to put their products in class I. Once again it's not only a matter of technical features but also of claimed intended use.
A simple viewer used to review original images could be a medical image storage device http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=892.2010 or medical image communication device http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=892.2020, depending on it context of use. But even a simple viewer, which intended use claims primary diagnosis, is most probably a class II PACS.
Likewise, as soon as software has features like MIP/MPR/ 3D, etc, odds are high that it is a PACS class II device. Hence these features are used for image interpretation.
I wonder what rationale used your competitor to put their products in class I. Once again it's not only a matter of technical features but also of claimed intended use.