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510(k) K874687

COLLI-MATETM MODEL NO. B800 by Summit Industries, Inc. — Product Code IZX

K874687 is an FDA 510(k) premarket notification submitted by Summit Industries, Inc. for the device "COLLI-MATETM MODEL NO. B800". The FDA issued a decision of Substantially Equivalent on December 30, 1987. The device falls under product code IZX (Collimator, Manual, Radiographic), a Class II device regulated under 21 CFR 892.1610. Summit Industries, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1987
Date Received
November 13, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collimator, Manual, Radiographic
Device Class
Class II
Regulation Number
892.1610
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)
  • 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)
  • K850118 — XMA INTEGRATED TABLE (April 9, 1985)

Other clearances for product code IZX

  • K110856 — RALCO (August 10, 2011)
  • K101036 — SHIMADZU COLLIMATOR R-20J (August 26, 2010)
  • K042840 — SHIMADZU COLLIMATOR R-20J (December 3, 2004)
  • K031771 — SHIMADZU COLLIMATOR R-30H (August 21, 2003)
  • K981267 — FACTS MONOBLOCK (May 6, 1998)
  • K974240 — LIGHTLINE-M (December 22, 1997)
  • K972966 — AXT 150M MANUAL COLLIMATOR (AXT 150M) (August 21, 1997)
  • K932134 — RINN UNIVERSAL COLLIMATOR (July 26, 1993)
  • K912180 — MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM (October 21, 1991)
  • K900007 — R-100-ET MANUAL COLLIMATOR (February 6, 1990)

FDA data resources