Home / 510(k) Clearances / K991842

510(k) K991842

SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING by Ge Vingmed Ultrasound — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1999
Date Received
May 28, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Ge Vingmed Ultrasound

  • K150087 — Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound (March 4, 2015)
  • K150085 — GE EchoPAC (March 2, 2015)
  • K141093 — 6VT-D ULTRASOUND TRANSDUCER (May 15, 2014)
  • K131685 — GE ECHOPAC (September 24, 2013)
  • K131514 — GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM (July 12, 2013)
  • K123894 — GE ECHOPAC (January 29, 2013)
  • K120201 — GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM (April 19, 2012)
  • K101149 — GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM (October 13, 2010)
  • K101324 — GE ECHOPAC MODEL BT10 (October 5, 2010)
  • K092756 — GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM (September 28, 2009)

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)