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Quantum QAD Angiodynograph Ultrasound System

by Quantum Medical Systems, Inc.

510(k) K894992

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK894992 Date23 Feb 1990ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 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  • Withdrawn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
MAA
Device Class
Class II
Regulation
21 CFR Part 884.2660
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Quantum QAD Angiodynograph Ultrasound System is a Monitor, Fetal Doppler Ultrasound designed for obstetric and gynecological applications. It employs ultrasound technology to visualize and assess blood flow dynamics within vascular structures, aiding in the evaluation of placental perfusion and fetal well-being. As a Class II device, it falls under regulatory oversight for devices requiring performance standards and pre-market notification.

This system is intended for use in radiology and obstetric settings, where real-time imaging of blood flow is critical. Supplied as a reusable medical device, it requires proper maintenance and calibration to ensure accurate diagnostic performance. The device holds an FDA 510(k) clearance (K894992) under the product code MAA, reflecting its compliance with U.S. regulatory requirements for fetal Doppler ultrasound systems. Storage and handling must adhere to manufacturer guidelines to preserve functionality and sterility where applicable.

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