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510(k) K780963

X-RAY SYSTEM by General X-Ray, Inc. — Product Code KPQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1978
Date Received
June 12, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Simulation, Radiation Therapy
Device Class
Class II
Regulation Number
892.5840
Review Panel
RA
Submission Type

Other clearances by General X-Ray, Inc.

  • K800998 — ATLAS-S X-RAY SYSTEM W/KETROMAT GEN. (May 28, 1980)
  • K790451 — X-RAY UNITS, GX-101, UCIS-510 AND GX-111 (March 28, 1979)
  • K790512 — PORTABLE X-RAY UNIT (March 26, 1979)
  • K790511 — MOBILE X-RAY UNIT (March 26, 1979)
  • K790392 — 510 CARBINETTE X-RAY UNIT (March 26, 1979)
  • K790393 — PORTABLE X-RAY UNIT, MATRIX S GX-101 (March 26, 1979)
  • K790443 — PORTABLE X-RAY UNIT (March 26, 1979)
  • K781675 — X-RAY COLLIMATOR (December 4, 1978)
  • K781975 — MOBILE CARRIER (December 4, 1978)
  • K781976 — MOBILE X-RAY UNIT (December 4, 1978)

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  • K101038 — RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER (August 17, 2010)
  • K090706 — ONCENTRA SIMULATION 2.3 (June 15, 2009)
  • K083591 — IKOENGELO, VERSION 2 (December 29, 2008)
  • K072445 — INTEGRATED BRACHYTHERAPY UNIT - DIGITAL (September 14, 2007)
  • K061006 — IKOENGELO (June 5, 2006)
  • K052361 — SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM (October 24, 2005)
  • K052345 — ADVANTAGE SIM MD (September 14, 2005)
  • K033470 — SIMULIX EVOLUTION (February 4, 2004)