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510(k) K250902

HeartFlow Analysis by HeartFlow, Inc. — Product Code PJA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2025
Date Received
March 26, 2025
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.

  • K213857 — HeartFlow Analysis (October 14, 2022)
  • K203329 — HeartFlow Analysis (January 8, 2021)
  • 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

  • K213857 — HeartFlow Analysis (October 14, 2022)
  • K213657 — DEEPVESSEL FFR (April 1, 2022)
  • K203329 — HeartFlow Analysis (January 8, 2021)
  • 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)