FDA 510(k)

MRI Planner

K-Number: K211841 · 2022-08-25

Decision Date2022-08-25

Product CodeMUJ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MRI Planner is the device name listed in this FDA 510(k) record. The listed applicant is Spectronic Medical AB. It received FDA 510(k) clearance on 2022-08-25 under 510(k) 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. The listed applicant is Spectronic Medical AB. The 510(k) number is K211841.

When did MRI Planner receive FDA 510(k) clearance?

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

Who is the listed applicant for MRI Planner?

The FDA 510(k) record lists Spectronic Medical AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MRI Planner?

The FDA product code for MRI Planner is MUJ.

Related Devices (Code: MUJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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