Home / 510(k) Clearances / K123894

510(k) K123894

GE ECHOPAC by Ge Vingmed Ultrasound AS — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2013
Date Received
December 18, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by Ge Vingmed Ultrasound AS

  • 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)
  • 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)
  • K991842 — SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING (June 11, 1999)

Other clearances for product code LLZ

  • K260479 — TheraSphere 360™ Y-90 Management Platform (March 13, 2026)
  • K253111 — Aeka Imaging (March 13, 2026)
  • K251964 — Mimics Thoracic Planner (March 12, 2026)
  • K253551 — VELYS™ Hip Navigation (March 6, 2026)
  • K253486 — SKIA-Head (Model: SKIA-ST00) (February 23, 2026)
  • K260205 — AS Software Version Asera (February 19, 2026)
  • K253927 — LiveMedica Enterprise PACS (February 6, 2026)
  • K251577 — LAIA XR (February 6, 2026)
  • K253639 — View (January 8, 2026)
  • K253784 — 3DICOM MD Cloud (January 8, 2026)