Home / 510(k) Clearances / K896543

510(k) K896543

ULTRAMARK 7 ULTRASOUND SYSTEM by Advanced Technology Laboratories, Inc. — Product Code DXK

K896543 is an FDA 510(k) premarket notification submitted by Advanced Technology Laboratories, Inc. for the device "ULTRAMARK 7 ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on February 15, 1990. The device falls under product code DXK (Echocardiograph), a Class II device regulated under 21 CFR 870.2330. Advanced Technology Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1990
Date Received
November 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Echocardiograph
Device Class
Class II
Regulation Number
870.2330
Review Panel
CV
Submission Type

Other clearances by Advanced Technology Laboratories, Inc.

  • K021966 — Q LAB SOFTWARE (July 2, 2002)
  • K011224 — HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, A (May 4, 2001)
  • K002144 — MEDLINK DIAGNOSTIC OFFLINE WORKSTATION (September 28, 2000)
  • K992470 — ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM (August 23, 1999)
  • K991671 — HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM (June 18, 1999)
  • K961459 — LEVEL 10 HDI (March 26, 1997)
  • K935009 — PEGASUS (October 11, 1994)
  • K940423 — NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUISITION MODULE (July 29, 1994)
  • K905248 — NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS (February 28, 1991)
  • K903603 — ULTRAMARK 9 ULTRASOUND SYSTEM (UM 9) (February 26, 1991)

Other clearances for product code DXK

  • K181042 — Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter (May 17, 2018)
  • K160173 — Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz Intr (February 26, 2016)
  • K031148 — IN-VISION IMAGING SYSTEM (May 28, 2003)
  • K934887 — 9750 ATHENA ETHERNET OPTION (January 14, 1994)
  • K913209 — ACCESSORY TO GENESIS III (GCFM) (May 15, 1992)
  • K911384 — CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 (June 25, 1991)
  • K904832 — MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST (April 22, 1991)
  • K904977 — CINE/VIEW PLUS - CARDIOLOGY WORKSTATION (February 25, 1991)
  • K904976 — CINE'VIEW - STRESS ECHO & IMAGE REVIEW (February 25, 1991)
  • K904975 — VISTA VIEWING STATION (February 25, 1991)

FDA data resources