Octostop Inc

Octostop Inc specializes in radiological positioning and shielding accessories. Their product line includes whole-body positioners for X-ray and radiation therapy, beam filters (like wedges) to adjust radiation intensity, paediatric-specific chairs for pediatric imaging, and protective shielding bibs. They also produce modular shielding boards, flannel blankets, and Velcro straps to secure positioning devices, all designed to enhance safety and precision in clinical imaging and therapy settings.

Octostop Inc is based in the United States. Their headquarters and operations are located within the country, which aligns with their regulatory compliance requirements for FDA-authorized devices.

Octostop Inc’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. These registries track devices that have undergone the necessary regulatory pathways for authorization in the US, ensuring traceability and compliance with medical device regulations.

Octostop Inc’s devices are primarily classified as Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with.

Devices like the ‘Universal Octopaque with Vertical Support’ and ‘Ridges Plus’ serve as radiation shielding accessories. The ‘Universal Octopaque’ is designed to provide adjustable shielding during X-ray or radiation therapy procedures, protecting patients from unnecessary exposure by absorbing or scattering radiation. ‘Ridges Plus’ likely refers to a modular shielding board with structural features to enhance stability and coverage, ensuring consistent protection during imaging or treatment.