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510(k) K851440

RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR by Summit Industries, Inc. — Product Code IXY

K851440 is an FDA 510(k) premarket notification submitted by Summit Industries, Inc. for the device "RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR". The FDA issued a decision of Substantially Equivalent on June 5, 1985. The device falls under product code IXY (Holder, Radiographic Cassette, Wall-Mounted), a Class I device regulated under 21 CFR 892.1880. Summit Industries, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1985
Date Received
April 10, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Radiographic Cassette, Wall-Mounted
Device Class
Class I
Regulation Number
892.1880
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)
  • K850198 — FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG (May 14, 1985)
  • K850118 — XMA INTEGRATED TABLE (April 9, 1985)
  • K850117 — XMA 325 (X-RAY GENERATOR) (April 9, 1985)

Other clearances for product code IXY

  • K953336 — VRS 3 WALL STAND (August 11, 1995)
  • K953402 — UNIVERSIX 190 (August 11, 1995)
  • K946114 — SENSORI-MOTOR RATING SCALE (April 28, 1995)
  • K946260 — NTBS-1417, 1436, TBS-1417 (March 31, 1995)
  • K930249 — BC/WT/PF (April 27, 1993)
  • K930230 — RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER (April 27, 1993)
  • K925934 — WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT (March 4, 1993)
  • K924445 — BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY (February 19, 1993)
  • K922443 — VERT-X UNIVERSAL VERTICAL BUCKY STAND (October 26, 1992)
  • K915667 — MODEL H170 PEDIATRIC CHEST X-RAY UNIT (January 31, 1992)

FDA data resources