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510(k) K837346

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

K837346 is an FDA 510(k) premarket notification submitted by Atomic Energy of Canada for the device "MODEL GAMMACELL 1000". The FDA issued a decision of Substantially Equivalent on June 24, 1983. The device falls under product code MOT (Irradiator, Blood To Prevent Graft Versus Host Disease), a Class U device. Atomic Energy of Canada has at least 5 other 510(k) clearances on record.

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)

Other clearances for product code MOT

  • K201177 — RadGil2 (August 17, 2020)
  • 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)

FDA data resources