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510(k) K201177

RadGil2 by R3 X-Ray L.L.C — Product Code MOT

K201177 is an FDA 510(k) premarket notification submitted by R3 X-Ray L.L.C for the device "RadGil2". The FDA issued a decision of Substantially Equivalent on August 17, 2020. 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
August 17, 2020
Date Received
May 1, 2020
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

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

FDA data resources