MRI Planner— 510(k) K211841

Substantially Equivalent

Spectronic Medical AB

FDA 510(k) clearance K211841 for MRI Planner, Substantially Equivalent on 2022-08-25. Applicant: Spectronic Medical AB.

Clearance details

Applicant: Spectronic Medical AB
Product code: Code MUJ
Advisory panel: Radiology
Date received: 2021-06-14
Decision date: 2022-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsingborg, SE

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