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510(k) K850198

FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG by Summit Industries, Inc. — Product Code IYB

K850198 is an FDA 510(k) premarket notification submitted by Summit Industries, Inc. for the device "FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG". The FDA issued a decision of Substantially Equivalent on May 14, 1985. The device falls under product code IYB (Tube Mount, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1770. Summit Industries, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1985
Date Received
January 18, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube Mount, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1770
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)
  • K850117 — XMA 325 (X-RAY GENERATOR) (April 9, 1985)
  • K850118 — XMA INTEGRATED TABLE (April 9, 1985)

Other clearances for product code IYB

  • K935123 — SUPERSTAND 300 (March 27, 1996)
  • K946261 — MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000 (February 15, 1995)
  • K941017 — F/C/W TUBESTAND (July 29, 1994)
  • K941004 — CTS SYSTEM (July 29, 1994)
  • K940442 — MPR-814 (June 9, 1994)
  • K935004 — MODEL ALPHA TS-2 (December 13, 1993)
  • K933253 — SUPERSTAND 3000 (August 16, 1993)
  • K925716 — BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC (December 17, 1992)
  • K925170 — SHIMADZU X-RAY TUBE STAND BH-100 SERIES (December 7, 1992)
  • K920727 — CEILING TUBE SUPPORT CH-30X (April 16, 1992)

FDA data resources