Home / 510(k) Clearances / K172087

510(k) K172087

SANGRAY by Hitachi , Ltd. — Product Code MOT

K172087 is an FDA 510(k) premarket notification submitted by Hitachi , Ltd. for the device "SANGRAY". The FDA issued a decision of Substantially Equivalent on October 27, 2017. The device falls under product code MOT (Irradiator, Blood To Prevent Graft Versus Host Disease), a Class U device. Hitachi , Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2017
Date Received
July 11, 2017
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 Hitachi , Ltd.

  • K201042 — PROBEAT-CR (July 13, 2020)
  • K191801 — PROBEAT-CR (September 13, 2019)
  • K163505 — ARIETTA PRECISION (May 30, 2017)
  • K162902 — ARIETTA Prologue Diagnostic Ultrasound system and Transducers (December 15, 2016)
  • K162583 — ALOKA LISENDO 880 (November 17, 2016)
  • K161163 — PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory (July 13, 2016)
  • K060834 — PROBEAT WITH MGCS (April 19, 2006)

Other clearances for product code MOT

  • K201177 — RadGil2 (August 17, 2020)
  • K181737 — Raycell MK1 (January 2, 2019)
  • 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