September 28, 2021
Concord, CA – Prowess Inc., a leading provider of advanced medical technology solutions, is proud to announce that its Panther OIS (Oncology Information System) has received clearance from the U.S. Food and Drug Administration (FDA) under Section 510(k) of the Federal Food, Drug, and Cosmetic Act. The Panther OIS has been cleared as a Class II medical device under regulation number 21 CFR 892.5050, designated for use in medical charged-particle radiation therapy systems.
The FDA’s substantial equivalence determination authorizes the Panther OIS to be marketed and used within the general controls provisions of the Act, ensuring compliance with critical regulatory requirements such as device registration, listing, and good manufacturing practices. This clearance signifies a major milestone in Prowess’ ongoing commitment to enhancing oncology care through innovative and reliable solutions.
The Panther OIS is designed to streamline clinical workflows and improve the delivery of oncology treatment, offering healthcare providers enhanced tools for patient management and radiation therapy coordination.
“We are thrilled to receive FDA clearance for Panther OIS, marking a pivotal step forward in our mission to empower oncology professionals with cutting-edge technology,” said Rachel Scarano, Regulatory Affairs Manager. “This clearance underscores our dedication to delivering high-quality solutions that meet stringent regulatory standards and improve patient outcomes.”
For more information about the Panther OIS or Prowess’ oncology solutions, please visit www.prowess.com or contact our support team at (925) 356-0360.