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510(k) K841649

MAXIMAX - 4 by Cgr Medical Corp. — Product Code IZP

K841649 is an FDA 510(k) premarket notification submitted by Cgr Medical Corp. for the device "MAXIMAX - 4". The FDA issued a decision of Substantially Equivalent on June 5, 1984. The device falls under product code IZP (Programmer, Changer, Film/Cassette, Radiographic), a Class II device regulated under 21 CFR 892.1870. Cgr Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1984
Date Received
April 20, 1984
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 by Cgr Medical Corp.

  • K843926 — PRESTILIX 1690 (December 17, 1984)
  • K843235 — STENOSCOP (November 8, 1984)
  • K843985 — SUSPENSION 7 (November 5, 1984)
  • K833223 — SONEL 3000A (May 9, 1984)
  • K834306 — PHASIX-HIGH FREQUENCY GENERATOR (December 29, 1983)
  • K833941 — ORION (December 29, 1983)
  • K833846 — PROCESS 100 ST (December 16, 1983)
  • K837412 — SATURNE I LINEAR ACCELERATOR (June 28, 1983)
  • K837465 — ALCYON ROTATIONAL COBALT THERAPY (June 28, 1983)
  • K837336 — VERASUN RADIATION THERAPY SIMULATION SYSTEM (April 29, 1983)

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)
  • K854251 — THE CSE FILM CHANGER SYSTEM (October 28, 1985)
  • K842903 — SEP PROGRAMMER FOR PUCK U & UD FILMCHANG (August 21, 1984)
  • K841732 — LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM (June 5, 1984)
  • K840389 — SEP PROGRAMMER SEP-M/SINGLE-PLANE & (February 21, 1984)

FDA data resources