
Servicing vs. Remanufacturing: Where CT and MRI Work Falls
The FDA's framework, set out in its finalized remanufacturing guidance, draws a bright line that shapes imaging service. Servicing is repair and preventive or routine maintenance that returns a finished device to the OEM's original safety and performance specifications; remanufacturing is work that significantly changes those specifications or the device's intended use, and it triggers premarket, registration, and quality-system obligations.
For high-throughput CT and MRI systems, that distinction governs how upgrades, part substitutions, and software changes are handled. Keeping activity firmly on the servicing side — restoring OEM specifications with documented calibration — is what keeps a facility's program straightforward and its accreditation evidence clean under Joint Commission environment-of-care expectations.
Sources: FDA — Remanufacturing of Medical Devices Guidance; The Joint Commission




































