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510(k) K827489

HYPERLUX 30 IMAGE SYSTEM by Cgr Medical Corp. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1982
Date Received
November 4, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

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  • 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)

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