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510(k) K212175

DynaCAD by Invivo Corporation — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2021
Date Received
July 12, 2021
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by Invivo Corporation

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  • K193403 — UroNav System (December 27, 2019)
  • K192200 — DynaCAD (October 9, 2019)
  • K182561 — UroNav (Version 3.0) (October 19, 2018)
  • K162177 — dS FootAnkle I6CH 1.5T Coil (September 14, 2016)
  • 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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