510(k) Investigational Device Notice

The PICS platform is a Software as a Medical Device (SaMD) currently under review for FDA 510(k) pre-market notification. Use of PICS is limited to investigational purposes under Institutional Review Board (IRB) oversight.

PICS is intended to assist licensed healthcare providers in monitoring postoperative patients by collecting patient-reported symptoms, generating alerts, and supporting clinical decision-making. It is NOT intended to replace physician judgment.

MDGenius AI is pursuing FDA 510(k) clearance for PICS as a Class II medical device. Until clearance is obtained, PICS is available only for investigational use by participating clinical sites under signed agreements.

• Obtain IRB approval or waiver
• Obtain informed consent from patients
• Report adverse events to MDGenius AI and the FDA
• Maintain records as required by 21 CFR Part 803