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510(k) K122035

HEPAFAT SCAN by Resonance Health Analysis Services Pty, Ltd. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2013
Date Received
July 11, 2012
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 Resonance Health Analysis Services Pty, Ltd.

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  • DEN130012 — FERRISCAN R2-MRI ANALYSIS SYSTEM (January 23, 2013)
  • K111222 — MRI-Q SYSTEM (July 28, 2011)

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