510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K232686Substantially Equivalent

CorVista® System

Corvista Health, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232686 is the FDA 510(k) clearance record for CorVista® System, a class II device, cleared for Corvista Health, Inc. on under FDA product code QXX (Coronary Artery Disease Machine Learning-Based Notification Software). FDA's definition for product code QXX reads: "Coronary Artery Disease machine learning-based notification software employs machine learning techniques to suggest the likelihood of coronary artery disease for further referral or diagnostic follow-up". FDA records list one 510(k) clearance for Corvista Health, Inc. As of , FDA records show no recalls naming K232686.

Clearance record

Decision date
Received
(7 days to decision)
Product code
QXX Coronary Artery Disease Machine Learning-Based Notification Software
Regulation
21 CFR 870.2380
Device class
Class II
Review panel
Cardiovascular
Applicant
Corvista Health, Inc. 7144 13th Pl. NW, Suite 2200, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QXX

Trailing 12 months

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

FDA records show no clearances under product code QXX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QXX, 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