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510(k) K092756

GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM by Ge Vingmed Ultrasound AS — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2009
Date Received
September 9, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
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)
  • 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)
  • K991842 — SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING (June 11, 1999)

Other clearances for product code ITX

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  • K250524 — Mendaera Guidance System (July 2, 2025)
  • K250469 — Accuro® 3S Needle Guide Kit (June 13, 2025)
  • K241662 — Ultrasound Transducer Cover (August 30, 2024)
  • K233965 — UltraDrape UGPIV Barrier and Securement (34-15) (August 15, 2024)
  • K241615 — Transducer Probe Cover (July 3, 2024)
  • K233109 — TP Pivot Pro™ Needle Guide (December 22, 2023)
  • K231666 — Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) (December 13, 2023)
  • K231783 — VitroPRO (November 14, 2023)