The current version of the medical device includes the Annotate, SmartFuse, SmartPlan and AdaptBox modules. The Annotate module allow the contouring of regions of interest. The module…
The current version of the medical device includes the Annotate, SmartFuse, SmartPlan and AdaptBox modules. The Annotate module allow the contouring of regions of interest. The module Smartplan allows the creation of an automatic treatment plan based on a planning CT and a RTSS The Smartfuse module is also providing the possibility to do a fusion of images from different modalities. The Adaptbox module is a helping tool to decide if a replanning is necessary. For this purpose, the module allows the user to generate a synthetic-CT from a CBCT image, to auto-delineate regions of interest on the synthetic-CT, to compute the dose on both planning CT and synthetic-CT and then define if there is a need for replanning by comparing volume and dose metrics computed on both images and over the course of the treatment. Those metrics are defined by the user. This version also contains an administration module, that allows the user to manage data and rights.
Who Else Makes It
Concentrated in Fujian (1), Beijing (1).
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.