Home / 510(k) Clearances / K893042

510(k) K893042

CATHSCANNER(R) INTRAVASCULAR ULTRA IMAGING SYSTEM by Endosonics Corp. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1989
Date Received
April 24, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

Other clearances by Endosonics Corp.

  • K000820 — AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700 (June 5, 2000)
  • K990271 — ENDOSONICS TRAK BACK DEVICE (August 30, 1999)
  • K982329 — VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900) (January 14, 1999)
  • K965223 — RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM (June 29, 1998)
  • K963290 — COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM (August 6, 1997)
  • K962293 — ENDOSONICS AUTOMATIC PULL BACK DEVICE (September 16, 1996)
  • K950276 — MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUN (September 22, 1995)
  • K944004 — VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300) (May 4, 1995)
  • K926252 — CATHSCANNER II INTRAVASCULAR ULTRASONIC IMAGING SY (October 25, 1993)
  • K924980 — CATHSCANNER VISIONS MICRORAIL ULTRA IMAG CATH (January 15, 1993)

Other clearances for product code IYN

  • K260595 — Sonosite iLOOK Ultrasound System (March 10, 2026)
  • K253049 — Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, (February 11, 2026)
  • K253597 — Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System (January 20, 2026)
  • K253370 — LOGIQ Totus (January 8, 2026)
  • K253366 — LOGIQ Fortis (January 7, 2026)
  • K252018 — HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; H (January 5, 2026)
  • K251268 — Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) (December 23, 2025)
  • K250959 — BioticsAI (December 22, 2025)
  • K252557 — Lumify Diagnostic Ultrasound System (December 22, 2025)
  • K252498 — Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 (December 5, 2025)