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510(k) K133692

IMRI 1.5T AND IMRI 3T S by Imris, Inc. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2014
Date Received
December 2, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Imris, Inc.

  • K143420 — SYMBIS Surgical System (October 30, 2015)
  • K141950 — HFD100 ROCKER ARM ACCESSORY (September 4, 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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  • K252379 — AIR Recon DL (December 23, 2025)
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