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510(k) K834306

PHASIX-HIGH FREQUENCY GENERATOR by Cgr Medical Corp. — Product Code ITY

K834306 is an FDA 510(k) premarket notification submitted by Cgr Medical Corp. for the device "PHASIX-HIGH FREQUENCY GENERATOR". The FDA issued a decision of Substantially Equivalent on December 29, 1983. The device falls under product code ITY (Assembly, Tube Housing, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1760. Cgr Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1983
Date Received
November 4, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assembly, Tube Housing, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1760
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)
  • K833941 — ORION (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)

Other clearances for product code ITY

  • K000052 — X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 (February 10, 2000)
  • K933162 — MRX-750 (October 7, 1993)
  • K923094 — MOLYBDENUM (March 4, 1993)
  • K923141 — PHILIPS PRE-FILTER OPTION (January 21, 1993)
  • K921129 — MRX-700 (October 5, 1992)
  • K921130 — MRX-865 (September 10, 1992)
  • K921316 — MG-1001 TUBE HOUSING ASSEMBLY (June 22, 1992)
  • K920731 — X-RAY TUBE ASSEMBLY CIRCLEX1.2UG (May 29, 1992)
  • K920724 — HIGH SPEED ROTATION STARTER SA-50 (April 27, 1992)
  • K920723 — HIGH SPEED ROTATION STARTER SA-40 (April 27, 1992)

FDA data resources