Technology | November 25, 2014

AZE Announces FDA Approval of Phoenix Volume Registration Viewer

New viewer allows background volume processing simultaneously with data input

Photo courtesy of AZE Technology

November 25, 2014 — AZE Technology announced the U.S. Food and Drug Administration (FDA) approval of Phoenix (Volume Registration Viewer), a viewer developed with a completely new concept for efficient and accurate image interpretation. Phoenix is designed to have background volume-processing performed at the same time as data input, and presents various dramatic outcomes that were not possible with existing viewers.

Phoenix was validated against the previously cleared predicate device VirtualPlace (K060453) (VP) from AZE Ltd. Two sample images were used for this validation: one thoracic computed tomography (CT) image and one thoracic magnetic resonance (MR) image. Three human observers made three independent observations of 13 measurements with corresponding measurement tools in the two software programs (Phoenix and VirtualPlace) from the CT and MR images.

The only significant differences between Phoenix and the market-cleared VirtualPlace software were RECIST measures. The increased lengths measured by the Phoenix RECIST tools were explained by Phoenix RECIST finding the longest distances and tightest edges. Additionally, measurements with Phoenix tools on a phantom of known diameter came within 2 percent of the known values. Phoenix’s measurement values can be considered valid because they do differ significantly from VirtualPlace or from known values of a phantom.

With tumor-size comparison by using fusion and superimposition, Phoenix allows radiologists to provide a greater amount of information quickly. The viewer can be used in tumor evaluation for cancer patients or any type of mass.

The RECIST measurement feature conforms fully with established international guidelines, in order to make judgments about a treatment’s effect on solid tumors. Phoenix obtains data from all aspects of the tumor, giving a higher level of information to the referring physicians and in return establishing accurate patient treatment.

Instant matching of section positions helps reduce the time involved in reading exams, which in return increases the turnaround of clinical reports.

Phoenix is enhanced with multiple advanced tools, hanging protocols and Smart Tags. AZE VirtualPlace 3-D workstation can also be interfaced with Phoenix.

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