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510(k) K994117

MR ENHANCER by I.Z.I. Corp. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2000
Date Received
December 6, 1999
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 I.Z.I. Corp.

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  • K993742 — SUPER TISSUE (February 2, 2000)
  • K930752 — CT/MRI TOPOGRAPHIC MARKER (November 19, 1993)
  • K922287 — E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS (October 16, 1992)

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