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510(k) K837346

MODEL GAMMACELL 1000 by Atomic Energy of Canada — Product Code MOT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1983
Date Received
March 16, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Irradiator, Blood To Prevent Graft Versus Host Disease
Device Class
Class U
Regulation Number
Review Panel
RA
Submission Type

Other clearances by Atomic Energy of Canada

  • K850543 — THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY (May 10, 1985)
  • K837347 — LINEAR ACCELERATOR THERAC 25 (June 24, 1983)
  • K837152 — THERAC 25 LINEAR ACCELERATOR (March 22, 1983)
  • K771260 — LINEAR ACCELERATOR G-2900 (August 3, 1977)
  • K771096 — TELHTHERAPY SIMULATOR AECL-CP, G-3200 (July 1, 1977)

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  • K181737 — Raycell MK1 (January 2, 2019)
  • K172087 — SANGRAY (October 27, 2017)
  • K161324 — Raycell Mk2 (August 12, 2016)
  • K082921 — RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 (February 17, 2009)
  • K051065 — RAYCELL X-RAY BLOOD IRRADIATOR (May 26, 2005)
  • K050963 — GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN (May 20, 2005)
  • K032684 — RAYCELL (September 26, 2003)
  • K974210 — SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000 (March 30, 1998)
  • K963497 — GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0 (November 8, 1996)