Home / 510(k) Clearances / K050963

510(k) K050963

GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN by Mds Nordion — Product Code MOT

K050963 is an FDA 510(k) premarket notification submitted by Mds Nordion for the device "GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN". The FDA issued a decision of Substantially Equivalent on May 20, 2005. The device falls under product code MOT (Irradiator, Blood To Prevent Graft Versus Host Disease), a Class U device. Mds Nordion has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2005
Date Received
April 18, 2005
Clearance Type
Special
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 Mds Nordion

  • K060870 — AVANZA (May 15, 2006)
  • K053485 — THERATRON EQUINOX, MODELS 80 CM AND 100 CM (March 9, 2006)
  • K051065 — RAYCELL X-RAY BLOOD IRRADIATOR (May 26, 2005)
  • K032684 — RAYCELL (September 26, 2003)
  • K020971 — DCM 2.0 (June 6, 2002)
  • K010682 — HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM (June 5, 2001)
  • K011246 — DCM 1.0 (May 23, 2001)
  • K001006 — THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE (April 27, 2000)

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)
  • 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)
  • K952291 — GAMMACELL 3000 ELAN (August 25, 1995)

FDA data resources