Proknow, LLC

Proknow, LLC specializes in developing radiological Picture Archiving and Communication Systems (PACS) software. These systems are designed to manage medical imaging data by securely storing, retrieving, and distributing digital images and associated reports in healthcare environments. The focus is on streamlining workflows for radiologists and clinicians while ensuring compliance with imaging data standards.

Proknow, LLC is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies Proknow’s PACS software as Class II devices, which typically require premarket notification (510(k)) submissions to demonstrate substantial equivalence to a legally marketed predicate device. This classification ensures that the software meets performance and safety standards before entering the market.

Proknow, LLC’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The 510(k) registry documents premarket submissions proving compliance with FDA requirements, while the UDI registry ensures each device has a unique, standardized identifier for tracking and traceability in healthcare settings. These registries help healthcare providers, regulators, and supply chain partners verify device legitimacy and compliance.

The FDA classifies Proknow’s PACS software as Class II devices, which means it poses moderate risk and requires specific controls to ensure safety and effectiveness. This classification requires manufacturers to submit a 510(k) premarket notification to demonstrate the device’s equivalence to a previously approved predicate. For users, this classification indicates that the software has undergone regulatory scrutiny to meet performance standards for managing medical imaging data securely and reliably.