510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203329Substantially Equivalent

HeartFlow Analysis

Heartflow, Inc., Redwood City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203329 is the FDA 510(k) clearance record for HeartFlow Analysis, a class II device, cleared for HeartFlow, Inc. on under FDA product code PJA (Coronary Vascular Physiologic Simulation Software). FDA's definition for product code PJA reads: "A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease". FDA records list 8 510(k) clearances for HeartFlow, Inc., from to . As of , FDA records show no recalls naming K203329.

Clearance record

Decision date
Received
(57 days to decision)
Product code
PJA Coronary Vascular Physiologic Simulation Software
Regulation
21 CFR 870.1415
Device class
Class II
Review panel
Cardiovascular
Applicant
HeartFlow, Inc. 1400 Seaport Blvd., Bldg. B, Redwood City CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PJA

Trailing 12 months

FDA records hold no clearances under product code PJA in the trailing twelve months.

FDA records show no clearances under product code PJA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PJA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260