FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND; RADIOG— 510(k) K850198

Clearance details

Device name as filed

FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG

Applicant

Summit Industries, Inc.

Product code

Code IYB

Device class

Class 1

Regulation

21 CFR 892.1770

Advisory panel

Radiology

Date received

1985-01-18

Decision date

1985-05-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Chicago, IL, US

• K935123 — SUPERSTAND 3001996-03-27
• K946261 — MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 50001995-02-15
• K941004 — CTS SYSTEM1994-07-29
• K941017 — F/C/W TUBESTAND1994-07-29
• K940442 — MPR-8141994-06-09

• K874908 — C900 X-RAY FILM PROCESSOR1988-02-12
• K874687 — COLLI-MATETM MODEL NO. B8001987-12-30
• K851440 — RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR1985-06-05
• K850117 — XMA 325 (X-RAY GENERATOR)1985-04-09
• K850118 — XMA INTEGRATED TABLE1985-04-09

• Z-0468-2015 — The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. The product consists of a vertical column (with counterbalanced vertical carriage, counterweight and pulley system), horizontal floor car and a floor mounted track to ride on.Class II·Terminated·Summit Industries Inc.·20141028

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K850198.