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510(k) K833846

PROCESS 100 ST by Cgr Medical Corp. — Product Code IZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1983
Date Received
September 15, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, High-Voltage, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1700
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)
  • K841649 — MAXIMAX - 4 (June 5, 1984)
  • K833223 — SONEL 3000A (May 9, 1984)
  • K834306 — PHASIX-HIGH FREQUENCY GENERATOR (December 29, 1983)
  • K833941 — ORION (December 29, 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 IZO

  • K954666 — MPH50, MPH65, AND MPH80 (November 24, 1995)
  • K953582 — HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR (September 26, 1995)
  • K953831 — N 800 HF (September 8, 1995)
  • K952822 — SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G (July 12, 1995)
  • K952265 — MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X- (July 6, 1995)
  • K950883 — POLYDOROS SX 65 AND 80 (April 3, 1995)
  • K950694 — COMPACT-X (March 31, 1995)
  • K950291 — DIGITAL 625HF (March 23, 1995)
  • K950041 — SII 360 APR (March 21, 1995)
  • K945453 — UD 150L-R II (March 21, 1995)