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510(k) K850118

XMA INTEGRATED TABLE by Summit Industries, Inc. — Product Code IXQ

K850118 is an FDA 510(k) premarket notification submitted by Summit Industries, Inc. for the device "XMA INTEGRATED TABLE". The FDA issued a decision of Substantially Equivalent on April 9, 1985. The device falls under product code IXQ (Table, Radiographic, Stationary Top), a Class II device regulated under 21 CFR 892.1980. Summit Industries, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1985
Date Received
January 14, 1985
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 Summit Industries, Inc.

  • K173823 — Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Rad (February 9, 2018)
  • K153119 — Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiog (March 14, 2016)
  • K874908 — C900 X-RAY FILM PROCESSOR (February 12, 1988)
  • K874687 — COLLI-MATETM MODEL NO. B800 (December 30, 1987)
  • K851440 — RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR (June 5, 1985)
  • K850198 — FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG (May 14, 1985)
  • K850117 — XMA 325 (X-RAY GENERATOR) (April 9, 1985)

Other clearances for product code IXQ

  • K973842 — CARBON FIBER CONFORMAL COUCH TOP (December 5, 1997)
  • K960083 — MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300 (July 24, 1996)
  • 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)

FDA data resources