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510(k) K955414

XRT 400 by Wuestec Medical, Inc. — Product Code KXJ

K955414 is an FDA 510(k) premarket notification submitted by Wuestec Medical, Inc. for the device "XRT 400". The FDA issued a decision of Substantially Equivalent on July 24, 1996. The device falls under product code KXJ (Table, Radiologic), a Class II device regulated under 21 CFR 892.1980. Wuestec Medical, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1996
Date Received
November 27, 1995
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 Wuestec Medical, Inc.

  • K993962 — PENSIL TRAUMA, MODEL WWS6100 (December 21, 1999)
  • K992603 — XRT 600 R/F, WRF 0600 (October 25, 1999)
  • K992103 — C-QUEST (September 1, 1999)
  • K981880 — DX-480, ADD ON DIGITAL IMAGER (October 20, 1998)
  • K974240 — LIGHTLINE-M (December 22, 1997)
  • K960083 — MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300 (July 24, 1996)
  • K935123 — SUPERSTAND 300 (March 27, 1996)
  • K933253 — SUPERSTAND 3000 (August 16, 1993)

Other clearances for product code KXJ

  • K050190 — APOLLO (March 25, 2005)
  • K963905 — RADIOGRAPHIC ITT TABLE (November 12, 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)
  • K922098 — CAG-02A (July 27, 1992)
  • K913121 — OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108/#6713.400 (August 16, 1991)

FDA data resources