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510(k) K974210

SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000 by Rad-Source, Inc. — Product Code MOT

K974210 is an FDA 510(k) premarket notification submitted by Rad-Source, Inc. for the device "SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000". The FDA issued a decision of Substantially Equivalent on March 30, 1998. 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
March 30, 1998
Date Received
November 10, 1997
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)
  • 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)
  • 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