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510(k) K242524

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2024
Date Received
August 23, 2024
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.)

  • K233733 — SyMRI (March 26, 2024)

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