Biokinemetrics, Inc.

Biokinemetrics, Inc. specializes in stationary digital x-ray systems and related components. Their primary focus is on stationary basic diagnostic x-ray systems, including standalone units and high-resolution digital sensors like flat panel detectors and wireless sensors (e.g., BIOK-4600, BIOK7600, Aquarius 8600 series). These devices are designed for capturing radiographic images in clinical settings.

Biokinemetrics, Inc. is based in the United States, meaning its devices are subject to U.S. medical device regulations. Since the company’s products fall under FDA Class II classification, they are regulated under the 510(k) premarket notification process and must comply with the Unique Device Identifier (UDI) system for traceability and tracking.

Biokinemetrics, Inc.’s devices are listed in FDA’s 510(k) premarket clearance database and the FDA’s Unique Device Identifier (UDI) registry. These registries ensure transparency in device authorization status, compliance requirements, and market availability under U.S. regulations.

Biokinemetrics, Inc.’s devices are classified as FDA Class II, which means they pose moderate risk and require premarket notification (510(k)) clearance before commercial distribution. This classification ensures they meet performance standards and safety requirements for diagnostic x-ray systems without needing the stricter controls of Class III devices.