Home / 510(k) Clearances / K093171

510(k) K093171

VIAMO SSA-640A VERSION 1.2 by Toshiba America Medical Systems, In.C — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2009
Date Received
October 8, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Toshiba America Medical Systems, In.C

  • K141472 — VANTAGE ELAN (September 19, 2014)
  • K133553 — KALARE (June 13, 2014)
  • K140729 — APLIO ARTIDA, V3.2 (May 23, 2014)
  • K132106 — INFINIX ANGIO WORKSTATION W/DTS SOFTWARE (November 12, 2013)
  • K131822 — ULTRAEXTEND USWS-900A V2.1 AND V3.1 (July 23, 2013)
  • K123097 — DOSE TRACKING SYSTEM MODEL XIDF-DTS801 (February 13, 2013)
  • K122613 — VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US (December 13, 2012)
  • K121076 — ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE (October 9, 2012)
  • K122842 — RADREX-I, SW V4.00 MODEL DRAD-3000E (October 9, 2012)
  • K122109 — AQUILION ONE VISION, V4.90 (September 21, 2012)

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)