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510(k) K960083

MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300 by Wuestec Medical, Inc. — Product Code IXQ

K960083 is an FDA 510(k) premarket notification submitted by Wuestec Medical, Inc. for the device "MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300". The FDA issued a decision of Substantially Equivalent on July 24, 1996. The device falls under product code IXQ (Table, Radiographic, Stationary Top), 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
January 11, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiographic, Stationary Top
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)
  • K955414 — XRT 400 (July 24, 1996)
  • K935123 — SUPERSTAND 300 (March 27, 1996)
  • K933253 — SUPERSTAND 3000 (August 16, 1993)

Other clearances for product code IXQ

  • K973842 — CARBON FIBER CONFORMAL COUCH TOP (December 5, 1997)
  • K954225 — MED-TEC HAND GRIP (November 14, 1995)
  • K946262 — EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLES (February 15, 1995)
  • K942916 — OCTOPAQUE UNIVERSAL (September 8, 1994)
  • K942190 — ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE (August 17, 1994)
  • K913425 — DIAL-A-RAD PORTA RAD TABLE (November 24, 1992)
  • K923775 — R-MADE HEAD/ARM SUPPORT (October 20, 1992)
  • K920729 — BUCKY TABLE BK-12 (April 27, 1992)
  • K914351 — CLINITRON C-10 (February 14, 1992)
  • K912382 — MILITARY RADIOGRAPHIC FLAT TABLE, CAT # T-9130 (October 10, 1991)

FDA data resources