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510(k) K191585

iNtuition-Structural Heart Module by Terarecon,Inc. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2019
Date Received
June 14, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Terarecon,Inc.

  • K250288 — TeraRecon Cardiovascular.Calcification.CT (October 23, 2025)
  • K243158 — TeraRecon Aorta.CT (1.1.0) (January 23, 2025)
  • K241312 — TeraRecon Cardiac.Chambers.MR (1.0.0) (November 5, 2024)
  • K220349 — TeraRecon Neuro (August 12, 2022)
  • K200750 — Neuro.Al Algorithm (November 6, 2020)
  • K180916 — iNtuition-T1 Mapping and T2/T2* Mapping (September 24, 2018)
  • K131447 — INTUITION - TDA, TVA, PARAMETRIC MAPPING (December 24, 2013)
  • K121916 — INTUITION (April 2, 2013)
  • K061214 — AQUARIUSAPS SERVER (May 15, 2006)
  • K012086 — AQUARIUSNET SERVER (September 13, 2001)

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