Irm, Inc.

Irm, Inc. specializes in radiological Picture Archiving and Communication Systems (PACS) software. These solutions focus on managing, storing, and viewing radiological images, as well as optimizing workflows in healthcare settings. Examples include platforms like i-Rapha View and i-Rapha Solution, which streamline image accessibility and diagnostic processes.

Irm, Inc. is based in the United States, which means its devices fall under FDA jurisdiction. The FDA classifies Irm’s products as either Class I or Class II, depending on their risk level and intended use. This classification determines the regulatory pathway for authorization, such as pre-market notifications (510(k)) or other submissions.

Irm, Inc.’s devices are listed in the FDA’s 510(k) database for pre-market submissions and the Unique Device Identifier (UDI) system for traceability. The 510(k) registry ensures transparency about device authorization pathways, while the UDI system standardizes identification for tracking, monitoring, and compliance purposes across the healthcare ecosystem.

The FDA classifies Irm, Inc.’s devices as either Class I (low-risk, generally exempt from strict controls) or Class II (moderate-risk, requiring special controls to ensure safety and effectiveness). This classification influences regulatory requirements, such as labeling, performance standards, or pre-market submissions like 510(k)s, ensuring appropriate oversight based on the device’s risk profile.