U.S. Food & Drug Administration grants 510(k) clearance for SOMATOM On.site.
Siemens Healthineers announced Wednesday it has secured 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its mobile head CT scanner SOMATOM On.site.
The system is designed to provide head imaging for critically patients without needing to transport them outside of the intensive care unit. Doing so eliminates both the risk and the cost of moving a patient to the radiology department, company officials said.
“The SOMATOM On.site transforms the delivery of care for critically ill patients who require a CT head scan,” said Douglas Ryan, vice president of computed tomography at Siemens Healthineers North America. “Bedside imaging helps to reduce patient transports, thereby reducing the risk of infection while improving workforce efficiency.”
According to company information, SOMATOM On.site can provide consistent patient positioning in the scanner through easy scan set-up, fast workflow, and integrated patient support accessories. The user interface – myExam Companion – assists the technologist with system navigation to ensure consistent results, and an integrated camera allows for easy maneuvering with real-time viewing on the built-in Touch UI display.
In addition, company officials said, the scanners telescopic gantry enables the technologist to move the radiation source away from the patient during scanning while the rest of the machine stays in place. And, based on company data, the telescopic, self-shielded gantry design with attachable front and back radiation shields reduces scatter radiation and provides radiation protection for neighboring patients and staff.