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MCG-S (AM1000)

by Amcg Co., Ltd.

510(k) K232823

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 NumberK232823 Date5 Apr 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  • Withdrawn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
DPS
Device Class
Class II
Regulation
21 CFR Part 870.2340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

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

The MCG-S (AM1000) is a magnetocardiography device classified as an electrocardiograph under the FDA’s classification name. It employs a non-invasive, non-contact, radiation-free technique to record biomagnetic signals from the heart, specifically measuring X- and Y-component ionic currents that underlie electrocardiographic activity. This multichannel body surface mapping system provides detailed biomagnetic data for diagnostic analysis in adult cardiology. The device operates without direct physical contact with the patient, distinguishing it from traditional ECG methods.

The MCG-S (AM1000) is supplied as a Class 2 Cardiovascular device under FDA product code DPS, cleared via the Traditional 510(k) pathway. It is intended for use in clinical settings where non-invasive cardiac signal measurement is required, though specific sterility or single-use/reusable status is not detailed in the regulatory submission. The device’s clearance (K232823) was granted on April 5, 2024, following a 205-day review by the FDA’s Cardiovascular (CV) advisory committee. No MRI safety or size specifications are provided in the available data.