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FDA 510(k)

MRI Planner

K-Number: K211841 · 2022-08-25

ApplicantSpectronic Medical AB
Decision Date2022-08-25
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MRI Planner is a medical device manufactured by Spectronic Medical AB. It received FDA 510(k) clearance on 2022-08-25 under approval number K211841. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRI Planner?

MRI Planner is a medical device that received FDA 510(k) clearance on 2022-08-25. It is manufactured by Spectronic Medical AB. The 510(k) number is K211841.

When was MRI Planner approved by the FDA?

MRI Planner received FDA 510(k) clearance on 2022-08-25, under approval number K211841.

What company makes MRI Planner?

MRI Planner is manufactured by Spectronic Medical AB.

What is the FDA product code for MRI Planner?

The FDA product code for MRI Planner is MUJ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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