This depends on the jurisdiction and on the specific intended use. Each jurisdiction needs to be considered in its own right.
For the FDA as an example, such systems (e.g., visual projectors intended for patient comfort, room ambiance, and fMRI stimulus) have been considered to be medical devices or accessories to medical devices (and thus regulated as medical devices themselves). For example, I have a client for whom the FDA officially concurred and established that their system is a medical device (by way of being an accessory to a device or by being a device itself) that falls into FDA medical device Product Code LNH (Nuclear Magnetic Resonance Imaging System) under FDA medical device classification regulation 21 CFR §892.1000. We have also seen other competitors held to the same standard; one I can think of as recently as 2019.
For Europe, we've also had a large multinational MRI manufacturer who uses these audio-visual devices consider them to be medical devices with respect to the manufacturer's medical device compliance obligations.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 23-Jan-2024 08:49
From: Shalini Yadav
Subject: MRI accessories
Hi, I would like to know during the MRI procedure if one uses the nonmagnetic audio video system would it be considered a device or entertainment system?