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510(k) K162177

dS FootAnkle I6CH 1.5T Coil by Invivo Corporation — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2016
Date Received
August 4, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Coil, Magnetic Resonance, Specialty
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

Other clearances by Invivo Corporation

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  • K212175 — DynaCAD (August 2, 2021)
  • K193403 — UroNav System (December 27, 2019)
  • K192200 — DynaCAD (October 9, 2019)
  • K182561 — UroNav (Version 3.0) (October 19, 2018)
  • K162001 — 1.5T and 3.0T 16 CH GE Shoulder Coils (August 31, 2016)
  • K152330 — Expression MR400 MRI Patient Monitoring System (December 23, 2015)
  • K153073 — UroNav (Version 2.0) (November 16, 2015)
  • K133030 — DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE) (January 22, 2014)

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