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ATL's Mark 100/300 Ultrasound Systems

by Advanced Technology Laboratories, Inc.

510(k) K811572

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 NumberK811572 Date10 Aug 1981ClearedStatusActive

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  • Withdrawn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
IYO
Device Class
Class II
Regulation
21 CFR Part 892.1560
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 ATL’s Mark 100/300 Ultrasound Systems are classified as a System, Imaging, Pulsed Echo, Ultrasonic, designed for diagnostic radiology applications. These devices utilize ultrasound technology to generate real-time imaging of internal body structures, enabling visualization of organs, tissues, and fluids for clinical assessment.

These systems are intended for use in radiology settings and were granted FDA 510(k) clearance under the Radiology advisory committee. They are supplied as reusable medical devices and fall under the Product Code IYO classification. No specific sterility or MRI safety details are provided in the regulatory records.

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