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510(k) K143420

SYMBIS Surgical System by Imris, Inc. — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2015
Date Received
November 28, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurological Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type

Other clearances by Imris, Inc.

  • K141950 — HFD100 ROCKER ARM ACCESSORY (September 4, 2014)
  • K133692 — IMRI 1.5T AND IMRI 3T S (February 10, 2014)
  • K130224 — ICT (July 18, 2013)
  • K123091 — VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T (December 27, 2012)
  • K121997 — IMRIS ONCOLOGY PACKAGE (August 10, 2012)
  • K113748 — IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) (March 23, 2012)
  • K103493 — HEAD FIATION DEVICE (HFD 100) (March 11, 2011)
  • K103506 — 1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300) (February 2, 2011)
  • K101813 — IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO (October 5, 2010)
  • K091166 — IMRX (September 2, 2009)

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