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510(k) K101813

IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO by Imris, Inc. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2010
Date Received
June 29, 2010
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 Imris, Inc.

  • K143420 — SYMBIS Surgical System (October 30, 2015)
  • 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)
  • K091166 — IMRX (September 2, 2009)

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  • K253779 — SIGNA™ Sprint Select (February 5, 2026)
  • K253499 — Ascent3T Neonatal Magnetic Resonance Imaging System (January 26, 2026)
  • K252379 — AIR Recon DL (December 23, 2025)
  • K252838 — MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETO (December 19, 2025)