510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260811Substantially Equivalent

Heartvue.Proton

Heartvue.ai, Inc., Brentwood TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K260811 is the FDA 510(k) clearance record for Heartvue.Proton, a class II device, cleared for Heartvue.ai, Inc. on under FDA product code QIH (Automated Radiological Image Processing Software). FDA's definition for product code QIH reads: "To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the...". As of , FDA records show no recalls naming K260811.

Clearance record

Decision date
Received
(167 days to decision)
Product code
QIH Automated Radiological Image Processing Software
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Applicant
Heartvue.ai, Inc. 1917 Parade Dr., Brentwood TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QIH

Trailing 12 months
87 clearances under product code QIH in the twelve months to October 2026, June 2026 the highest month at 11.
Show the numbers
Monthly 510(k) clearances under FDA product code QIH, trailing twelve months
MonthClearances
November 20253
December 202510
January 20265
February 20264
March 20268
April 202610
May 202610
June 202611
July 20269
August 20268
September 20269
October 20260