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510(k) K203329

HeartFlow Analysis by HeartFlow, Inc. — Product Code PJA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2021
Date Received
November 12, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coronary Vascular Physiologic Simulation Software
Device Class
Class II
Regulation Number
870.1415
Review Panel
CV
Submission Type

A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.

Other clearances by HeartFlow, Inc.

  • K250902 — HeartFlow Analysis (July 18, 2025)
  • K213857 — HeartFlow Analysis (October 14, 2022)
  • K190925 — HeartFlow FFRct Analysis (August 15, 2019)
  • K182035 — FFRct (December 6, 2018)
  • K161772 — FFRct (August 24, 2016)
  • K152733 — FFRct (January 13, 2016)
  • DEN130045 — HEARTFLOW FFRCT (November 26, 2014)

Other clearances for product code PJA

  • K250902 — HeartFlow Analysis (July 18, 2025)
  • K213857 — HeartFlow Analysis (October 14, 2022)
  • K213657 — DEEPVESSEL FFR (April 1, 2022)
  • K190925 — HeartFlow FFRct Analysis (August 15, 2019)
  • K182035 — FFRct (December 6, 2018)
  • K161772 — FFRct (August 24, 2016)
  • K152733 — FFRct (January 13, 2016)
  • DEN130045 — HEARTFLOW FFRCT (November 26, 2014)