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Ultramark 9 High Definition Imaging Ultrasound System

by Advanced Technology Laboratories, Inc.

PMA P940005510(k) K896543

Active United States

PMA, withdrawn 510(k)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), FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMA PMA NumberP940005 Date11 Apr 1996ApprovedStatusWithdrawn
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK896543 Date15 Feb 1990ClearedStatusActive

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  • Withdrawn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), FDA PMA Active

Specification

510(k) · PMA

Full name
Ultramark 9 High Definition Imaging Uultrasound System
Generic Name
System, imaging, pulsed doppler, ultrasonic
PMA Number
510(k) Number
FDA Product Code
DXK
Device Class
Class II
Regulation
21 CFR Part 870.2330
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Ultramark 9 High Definition Imaging Ultrasound System is a pulsed doppler ultrasonic imaging device designed for cardiovascular diagnostic procedures. It utilizes high definition imaging technology to provide detailed visualization for clinical assessment.

This system is manufactured by Advanced Technology Laboratories, Inc. and is authorized for use under FDA 510(k) and PMA regulatory pathways. The system is compatible with the L10-5 scanhead to facilitate its imaging functions.

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Questions

AI-generated answers, 18 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 Ultramark 9 system?

    The Ultramark 9 is a pulsed doppler ultrasonic imaging system intended for use in cardiovascular diagnostic imaging.

  • Which scanhead is compatible with this ultrasound system?

    The system is specifically authorized for use with the L10-5 scanhead to perform its high definition imaging functions.

  • What regulatory authorizations does the Ultramark 9 hold?

    The device has received both FDA 510(k) clearance and PMA approval, confirming its regulatory status for clinical use.