Magnetic Resonance (MR) Receive-only Coil - Performance Crit

Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway


Center for Devices and Radiological Health
This guidance provides performance criteria for magnetic resonance (MR) receive-only coils in support of the Safety and Performance Based Pathway. Under this framework, submitters (you) planning to submit a 510(k) using the Safety and Performance Based Pathway for MR receive-only coils will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.
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Related Keywords

, Radiological Health , Guidance Issuing Office , Drug Administration , Docket Number , Performance Based , Performance Based Pathway , Consensus Standards , Appropriate Use , Voluntary Consensus Standards , Premarket Submissions , கதிரியக்கவியல் ஆரோக்கியம் , வழிகாட்டல் வழங்குதல் அலுவலகம் , டாக்கெட் எண் , செயல்திறன் அடிப்படையிலானது , செயல்திறன் அடிப்படையிலானது நடைபாதை , ஒருமித்த கருத்து தரநிலைகள் , பொருத்தமானது பயன்பாடு , தன்னார்வ ஒருமித்த கருத்து தரநிலைகள் ,

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