Decisio Health, Inc.

Decisio Health, Inc. specializes in clinical management support software, particularly patient-facing tools like the *Decisio Health Patient Dashboard*. These solutions are designed to organize and present patient health data in a structured way, aiding clinicians and patients in making informed decisions. Since the devices are software-based, they fall under the FDA’s classification for digital health tools.

Decisio Health, Inc. is headquartered in the United States, meaning its devices must comply with FDA regulations. The company’s products are classified as Class II devices, which typically require premarket notification (510(k)) and Unique Device Identification (UDI) registration to demonstrate safety and effectiveness before entering the market.

Decisio Health’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) database confirms that each product has undergone FDA review to show it’s substantially equivalent to a legally marketed predicate device. The UDI system ensures traceability and transparency in the supply chain, helping track devices from manufacturing to patient use—critical for recalls, compliance, and post-market surveillance.

Decisio Health’s devices are classified as FDA Class II, which means they pose moderate risk and require regulatory oversight. This classification necessitates premarket submission (like a 510(k)) to prove the device’s safety and performance. For users, this classification indicates that the software has undergone FDA scrutiny to ensure it meets established standards for clinical management support tools, reducing risks associated with data accuracy and decision-making.