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510(k) K994283

MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM by Medis Medical Imaging Systems BV — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2000
Date Received
December 20, 1999
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 Medis Medical Imaging Systems BV

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  • K073156 — QPLAQUE MR (March 4, 2008)
  • K062386 — QANGIO CT (October 5, 2006)
  • K050703 — QBRAIN (April 21, 2005)
  • K042383 — RSA-CMS (October 20, 2004)
  • K041162 — ORTHO-CMS (July 27, 2004)
  • K040746 — MRA-CMS (June 8, 2004)
  • K033774 — CT-MASS (March 2, 2004)

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  • K253499 — Ascent3T Neonatal Magnetic Resonance Imaging System (January 26, 2026)
  • K252379 — AIR Recon DL (December 23, 2025)
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