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FDA 510(k)

RSI-MRI+

K-Number: K191278 · 2019-11-19

ApplicantMultimodal Imaging Services Corporation (Dba Healthlytix)
Decision Date2019-11-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RSI-MRI+ is a medical device manufactured by Multimodal Imaging Services Corporation (Dba Healthlytix). It received FDA 510(k) clearance on 2019-11-19 under approval number K191278. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RSI-MRI+?

RSI-MRI+ is a medical device that received FDA 510(k) clearance on 2019-11-19. It is manufactured by Multimodal Imaging Services Corporation (Dba Healthlytix). The 510(k) number is K191278.

When was RSI-MRI+ approved by the FDA?

RSI-MRI+ received FDA 510(k) clearance on 2019-11-19, under approval number K191278.

What company makes RSI-MRI+?

RSI-MRI+ is manufactured by Multimodal Imaging Services Corporation (Dba Healthlytix).

What is the FDA product code for RSI-MRI+?

The FDA product code for RSI-MRI+ is LLZ.

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Official Source

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