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510(k) K833941

ORION by Cgr Medical Corp. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1983
Date Received
November 15, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
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)
  • K833846 — PROCESS 100 ST (December 16, 1983)
  • K837465 — ALCYON ROTATIONAL COBALT THERAPY (June 28, 1983)
  • K837412 — SATURNE I LINEAR ACCELERATOR (June 28, 1983)
  • K837336 — VERASUN RADIATION THERAPY SIMULATION SYSTEM (April 29, 1983)

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