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510(k) K233733

SyMRI by Syntheticmr AB (Publ.) — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2024
Date Received
November 21, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

Other clearances by Syntheticmr AB (Publ.)

  • K242524 — SyMRI (December 6, 2024)

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