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510(k) K113511

ECHOSTAR SPICA 1.5T MR SYSTEM by Alltech Medical Systems America, Inc. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2012
Date Received
November 28, 2011
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 Alltech Medical Systems America, Inc.

  • K163192 — Comfort EC710 (April 10, 2017)
  • K141945 — ECHOSTAR COMFORT 1.5T MRI (February 3, 2015)
  • K082100 — ALLTECH ECHOSTAR 1.5 T MR SYSTEM (August 6, 2008)

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