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Mark 100 & 300 Ultrasound System

by Advanced Technology Laboratories, Inc.

510(k) K820365

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 NumberK820365 Date26 Mar 1982ClearedStatusActive

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  • Withdrawn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, 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 Mark 100 & 300 Ultrasound System is a diagnostic imaging device classified under the product code IYO, designed for radiologic examination. It generates high-frequency sound waves to create real-time visual images of internal body structures, aiding in the assessment of organs, tissues, and blood flow. This system is intended for use in clinical settings to support diagnostic procedures such as obstetrics, cardiology, and abdominal imaging. Its functionality relies on ultrasound technology to provide non-invasive, radiation-free diagnostic capabilities.

The Mark 100 & 300 Ultrasound System is supplied as a reusable medical device and is intended for use in radiology departments or imaging centers. It was granted FDA 510(k) clearance under the traditional review pathway, with a decision date of March 26, 1982, and is classified as substantially equivalent to predicate devices. The system is not specified as MRI-safe or sterile upon delivery, requiring appropriate cleaning and maintenance protocols as outlined in manufacturer guidelines. Storage and handling must comply with standard medical device regulations to ensure optimal performance and patient safety.

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