Home / 510(k) Clearances / K903085

510(k) K903085

SMS-712NA by Toshiba America Medical Systems, In.C — Product Code GXW

K903085 is an FDA 510(k) premarket notification submitted by Toshiba America Medical Systems, In.C for the device "SMS-712NA". The FDA issued a decision of Substantially Equivalent on October 5, 1990. The device falls under product code GXW (Echoencephalograph), a Class II device regulated under 21 CFR 882.1240. Toshiba America Medical Systems, In.C has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1990
Date Received
July 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Echoencephalograph
Device Class
Class II
Regulation Number
882.1240
Review Panel
NE
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 GXW

  • K921863 — SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS (September 28, 1992)
  • K853432 — 5.0 IOP & 7.5 IOP PROBES (February 7, 1986)
  • K833522 — NEURO SECTOR FIXATION DEVICE (May 25, 1984)
  • K821736 — ECHO-PULSE KM555 (December 9, 1982)
  • K770788 — ECHOENCEPHALOGRAPH, DIGITAL,DIGIECHO2000 (May 6, 1977)
  • K770575 — ECHOENCEPHALOGRAPH, DIGITAL, 1000 (April 26, 1977)

FDA data resources