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510(k) K121997

IMRIS ONCOLOGY PACKAGE by Imris, Inc. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2012
Date Received
July 9, 2012
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.

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  • 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)
  • 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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  • K260265 — MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (February 23, 2026)
  • K253780 — SIGNA™ Bolt (February 6, 2026)
  • 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)