How does the 510(k) process address cybersecurity concerns for medical devices?

Apr 2, 2024 ... "Olympus is your trusted stone management partner and now is positioned to provide access to a broad range of high-quality ureteroscopes, ... Jan 10, 2013 ... Because many predicates have never been assessed for safety and effectiveness, an FDA finding of substantial equivalence does not mean that a ... Aug 12, 2021 ... When a medical device is cleared, this means it has undergone a 510(k) submission, which the FDA has reviewed and provided clearance. For Class ... Nov 20, 2024 ... “THINK Surgical is excited to add the MOBIO™ Total Knee System to the TMINI System. The open platform version of TMINI is now available with ... Physiomesh for market pursuant to its 510(k) process, which means that the FDA ... the Court finds that any probative value of the FDA 510(k) clearance is ... Leading letter “K” indicates 510(k) clearance, or Premarket Notification. This is an .exact field. It has been indexed both as its exact string content, and ... 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 ... Apr 16, 2017 ... FDA's analysis of whether to exempt a type of device from the 510(k) requirements is specific to the devices within the generic category in ... • Devices approved by the FDA through the Pre-Market Approval (PMA) process;. • Devices cleared by the FDA through the 510(k) process;. • FDA-approved ... Dec 10, 2019 ... The InSet™ Total Shoulder System is used to treat significant disability in degenerative, rheumatoid, and traumatic disease of the glenohumeral ...