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510(k) K922098

CAG-02A by Toshiba America Medical Systems, In.C — Product Code KXJ

K922098 is an FDA 510(k) premarket notification submitted by Toshiba America Medical Systems, In.C for the device "CAG-02A". The FDA issued a decision of Substantially Equivalent on July 27, 1992. The device falls under product code KXJ (Table, Radiologic), a Class II device regulated under 21 CFR 892.1980. Toshiba America Medical Systems, In.C has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1992
Date Received
May 6, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiologic
Device Class
Class II
Regulation Number
892.1980
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)

Other clearances for product code KXJ

  • K050190 — APOLLO (March 25, 2005)
  • K963905 — RADIOGRAPHIC ITT TABLE (November 12, 1996)
  • K955414 — XRT 400 (July 24, 1996)
  • K951146 — IMAGING TABLE (May 4, 1995)
  • K950068 — CARBON FIBER COUCH INSERT (April 6, 1995)
  • K950442 — INFRARED EXPOSURE HAND SWITCH (March 31, 1995)
  • K940696 — SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5 (March 16, 1994)
  • K931724 — ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES (June 14, 1993)
  • K926407 — MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM (March 31, 1993)
  • K913121 — OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108/#6713.400 (August 16, 1991)

FDA data resources