Ims Giotto S.P.A.

Ims Giotto S.P.A. specializes in diagnostic imaging devices. Their portfolio includes the Giotto Class series (models 3000X-YY and 4000X-YY), which are designed for medical imaging applications, and the SMART FINDER, a device used for locating and identifying implanted medical components. These products are developed to assist in precise medical diagnostics and procedural guidance.

Ims Giotto S.P.A. has a presence in the United States, which means its devices are subject to FDA regulatory requirements. Since the company’s products fall under the FDA’s Class II classification, they must comply with the agency’s regulations, including pathways like the 510(k) pre-market submission process for demonstrating substantial equivalence to existing approved devices.

Ims Giotto S.P.A.’s devices are listed in the FDA’s 510(k) registry. This pathway is used for Class II devices to demonstrate that they are substantially equivalent to legally marketed predicates, ensuring compliance with U.S. regulatory standards before commercial distribution.

Ims Giotto S.P.A.’s devices are classified as FDA Class II. This classification indicates moderate risk, requiring special controls beyond general controls to ensure safety and effectiveness. The company’s products must meet these controls, often validated through the 510(k) process, to confirm they meet regulatory requirements before being marketed.