Home / 510(k) Clearances / K961459

510(k) K961459

LEVEL 10 HDI by Advanced Technology Laboratories, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1997
Date Received
April 16, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
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)
  • 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)
  • K901329 — CEPHALIC DOPPLER W/ULTRAMARK 9 ULTRASOUND SYSTEM (November 23, 1990)

Other clearances for product code IYO

  • K253898 — QT Scanner 2000 Model A (March 4, 2026)
  • K253714 — IntraSight Plus (February 24, 2026)
  • K253221 — Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) (February 6, 2026)
  • K250331 — Astrasono A3Pro Bladder Scanner (A3Pro) (September 30, 2025)
  • K250381 — Deepsight NeedleVue LC1 Ultrasound System (August 1, 2025)
  • K243227 — B-Scan (July 11, 2025)
  • K251728 — Velacur One (LI-1100) (June 26, 2025)
  • K243880 — Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini (June 17, 2025)
  • K243937 — Accuro 3S (May 23, 2025)
  • K243479 — EchoGuide (Version 1) (April 23, 2025)