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510(k) K082921

RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 by Rad Source Technologies, Inc. — Product Code MOT

K082921 is an FDA 510(k) premarket notification submitted by Rad Source Technologies, Inc. for the device "RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400". The FDA issued a decision of Substantially Equivalent on February 17, 2009. The device falls under product code MOT (Irradiator, Blood To Prevent Graft Versus Host Disease), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2009
Date Received
October 1, 2008
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 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)
  • 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)
  • K952291 — GAMMACELL 3000 ELAN (August 25, 1995)

FDA data resources