What are the requirements for importing medical devices into the United States?

Sep 19, 2023 ... The T2Biothreat Panel is a direct-from-blood molecular diagnostic test that runs on the FDA-cleared T2Dx® Instrument and simultaneously detects six biothreat ... Jan 30, 2023 ... ... dose concerns mean CT is not optimal. Adaptix's central mission is to transform radiology by offering affordable low-dose 3D imaging at the ... Companies can submit a 510(k) — also known as a premarket notification (PMN) — to the FDA to show that the device is substantially equivalent. This process is ... Oct 4, 2023 ... Anumana's ECG-AI LEF is an innovative software-as-a-medical device (SaMD) designed to screen for LEF in adults at risk for heart failure. Aug 4, 2022 ... “When Xoran states that TRON is the 'One RING to rule them all,' we truly mean that this compact, mobile, open-bore device is poised to ... 8 days ago ... Laser endoscopy ophthalmic system receives FDA 510(k) clearance · Study: Home OCT impacts physician decision making · FDA does ... The mean IOP ... The goal of a FDA 510k submission is to demonstrate that the device being brought to market is at least as safe and effective to another legally marketed ... Mar 14, 2024 ... The US Food and Drug Administration (FDA) provided 510(k) clearance for da Vinci 5, the company's next-generation multiport robotic system. The FDA 510(k) Program is occasionally referred to as premarket notification. It allows a new medical device to gain FDA approval by establishing a set of ... Jun 5, 2024 ... A legally marketed predicate means the device has previously gone through a 510(k) clearance process and obtained FDA clearance or was on the ...