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510(k) K014022

MRI LINE MARKER by I.Z.I. Corp. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2002
Date Received
December 6, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

Other clearances by I.Z.I. Corp.

  • K022074 — SPHERZ (August 13, 2002)
  • K003736 — MRI LINE MARKER (January 18, 2001)
  • K994117 — MR ENHANCER (February 4, 2000)
  • 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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