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510(k) K914583

TOSBEE by Toshiba America Medical Systems, In.C — Product Code IYD

K914583 is an FDA 510(k) premarket notification submitted by Toshiba America Medical Systems, In.C for the device "TOSBEE". The FDA issued a decision of Substantially Equivalent on January 28, 1993. The device falls under product code IYD (Generator, Low Voltage, Therapeutic X-Ray), a Class II device regulated under 21 CFR 892.5900. Toshiba America Medical Systems, In.C has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1993
Date Received
October 16, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Low Voltage, Therapeutic X-Ray
Device Class
Class II
Regulation Number
892.5900
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)
  • K122842 — RADREX-I, SW V4.00 MODEL DRAD-3000E (October 9, 2012)
  • K121076 — ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE (October 9, 2012)
  • K122109 — AQUILION ONE VISION, V4.90 (September 21, 2012)

FDA data resources