Does regulatory clearance mean a tool will work safely at our organization?
No, and treating it that way is a known failure mode.
Regulatory authorization is granted against a specific intended use and a specific body of evidence, typically generated on populations and in settings that may not resemble yours. It establishes that a product met a regulatory bar. It does not establish that the product performs equivalently on your patients, with your data, in your workflow.
It also says nothing about whether the deployment will be used correctly, monitored, or maintained. Local validation and post-deployment monitoring are separate obligations that regulatory status does not discharge.
Note also that approved, cleared, authorized, and certified are distinct regulatory terms with different meanings and different evidentiary bars. They are not interchangeable, and vendor materials sometimes use them loosely.