Annalise-Ai

Annalise-Ai specializes in AI-powered diagnostic tools designed to analyze chest X-rays. Their primary product, the Annalise Enterprise CXR Triage Pneumothorax, focuses on detecting pneumothorax—a condition where air leaks into the space between the lung and chest wall—from radiographic images. These tools leverage artificial intelligence to assist radiologists and clinicians in identifying potential medical concerns more efficiently.

Annalise-Ai is headquartered in the United States. Since the company operates within the U.S., its medical devices are subject to FDA regulations. The Annalise Enterprise CXR Triage Pneumothorax falls under FDA Class II classification, which typically requires premarket notification (510(k)) clearance to demonstrate substantial equivalence to a legally marketed predicate device before commercial distribution.

Annalise-Ai’s devices, including the Annalise Enterprise CXR Triage Pneumothorax, are listed in the FDA’s 510(k) clearance database. This registry confirms that the device has undergone the required premarket review process to ensure it meets FDA safety and effectiveness standards before being marketed in the U.S. The listing serves as public documentation of the device’s regulatory status.

Annalise-Ai’s devices, such as the Annalise Enterprise CXR Triage Pneumothorax, are classified as FDA Class II medical devices. This classification is determined by the FDA based on the device’s intended use and risk level. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness, including the submission of a 510(k) clearance to demonstrate compliance with these controls before market authorization.