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510(k) K854251

THE CSE FILM CHANGER SYSTEM by Changer Service & Engineering, Inc. — Product Code IZP

K854251 is an FDA 510(k) premarket notification submitted by Changer Service & Engineering, Inc. for the device "THE CSE FILM CHANGER SYSTEM". The FDA issued a decision of Substantially Equivalent on October 28, 1985. The device falls under product code IZP (Programmer, Changer, Film/Cassette, Radiographic), a Class II device regulated under 21 CFR 892.1870.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1985
Date Received
October 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Programmer, Changer, Film/Cassette, Radiographic
Device Class
Class II
Regulation Number
892.1870
Review Panel
RA
Submission Type

Other clearances for product code IZP

  • K934944 — MPQ-42 (December 15, 1993)
  • K911888 — PHILIPS ANGIOPRO (October 15, 1991)
  • K904144 — PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEM (December 13, 1990)
  • K904103 — SEP 90 (November 20, 1990)
  • K874451 — OMNIPLANE 200 FILM CHANGER SYSTEM (February 11, 1988)
  • K842903 — SEP PROGRAMMER FOR PUCK U & UD FILMCHANG (August 21, 1984)
  • K841732 — LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM (June 5, 1984)
  • K841649 — MAXIMAX - 4 (June 5, 1984)
  • K840389 — SEP PROGRAMMER SEP-M/SINGLE-PLANE & (February 21, 1984)

FDA data resources