CAPTION HEALTH, INC.

Caption Health, Inc. specializes in software and tools designed for cardiac imaging analysis. Their portfolio includes automated ejection fraction measurement software and guidance systems for interpreting cardiac ultrasound images, such as Caption Interpretation Automated Ejection Fraction Software and Caption Guidance. These tools assist healthcare professionals in analyzing and interpreting cardiac ultrasound data more efficiently.

Caption Health, Inc. is based in the United States. Since the company operates in the U.S., its devices are subject to FDA regulations, which is why their records appear in the FDA’s 510(k) registry. Additionally, their devices are listed in EUDAMED, indicating they are also marketed or intended for use in the European Economic Area, where compliance with EU Medical Device Regulations applies.

Caption Health, Inc.’s devices are listed in two key regulatory registries: the FDA’s 510(k) database and EUDAMED. The FDA 510(k) registry tracks devices that have undergone premarket notification to demonstrate substantial equivalence to a predicate device, ensuring compliance with U.S. regulations. EUDAMED, on the other hand, is the EU’s central database for medical devices, where manufacturers must register their products to comply with EU Medical Device Regulations, ensuring traceability and transparency in the market.

Caption Health, Inc.’s devices fall under Class II and Class IIa classifications. These classifications are determined based on the risk associated with the device. Class II devices pose moderate risks and require special controls to ensure safety and effectiveness, while Class IIa devices are a subset of Class II with slightly lower risk profiles but still require regulatory oversight. The classification influences the regulatory pathway and scrutiny these devices undergo before market authorization.

Devices listed in both the FDA’s 510(k) registry and EUDAMED are likely marketed or intended for use in both the United States and the European Economic Area. The FDA’s 510(k) process ensures these devices meet U.S. safety and performance standards, while EUDAMED registration confirms compliance with EU Medical Device Regulations. Listing in both databases reflects the company’s global market presence and adherence to multiple regulatory requirements.