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AutoChamber

by Heartlung Corporation

510(k) K240786

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK240786 Date10 Oct 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
QIH
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

AutoChamber is an AI-enabled medical device designed for the early detection of heart disease. It utilizes artificial intelligence technology to provide automated analysis for cardiovascular health assessment.

This device is authorized via FDA 510K clearance under the K240786 submission. It is intended for use by healthcare providers to assist in clinical settings.

Other devices from Heartlung Corporation

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the AutoChamber device?

    AutoChamber is an AI-enabled medical device intended for use by healthcare providers to assist in the early detection of heart disease. It utilizes artificial intelligence technology to provide automated analysis for cardiovascular health assessments.

  • What is the regulatory status of the AutoChamber?

    The AutoChamber has received FDA 510K clearance under submission number K240786. This indicates that the device has been determined to be substantially equivalent to a predicate device for its intended use.

  • Who is the intended user for this device?

    The device is intended for use by healthcare providers within clinical settings. It is designed to support these professionals by providing automated analysis to aid in cardiovascular health assessment.