Sangray
FDA 510(k) K172087 · Hitachi , Ltd.
510(k) numberK172087
Submission
- Device name
- Sangray
- Applicant
- Hitachi , Ltd.
Kashiwa-Shi, JP - Received
- July 11, 2017
- Decision date
- October 27, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MOT – Irradiator, Blood To Prevent Graft Versus Host Disease
- Device class
- Unclassified
Other 510(k)s with product code MOT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201177 | RadGil2MOT · Traditional | R3 X-Ray L.L.C | 08/17/2020SE |
| K181737 | Raycell MK1MOT · Traditional | Best Theratronics Limited | 01/02/2019SE |
| K161324 | Raycell Mk2MOT · Special | Best Theratronics Limited | 08/12/2016SE |
| K082921 | Rad Source X-Ray Blood Irradiator, Model RS-3400MOT · Traditional | Rad Source Technologies, Inc. | 02/17/2009SE |
| K051065 | Raycell X-Ray Blood IrradiatorMOT · Special | Mds Nordion | 05/26/2005SE |
| K050963 | Gammacell 1000 Elite and Gammacell 3000 ElanMOT · Special | Mds Nordion | 05/20/2005SE |
| K032684 | RaycellMOT · Special | Mds Nordion | 09/26/2003SE |
| K974210 | Shielded Cabinet X-Ray Radiation Source Device Model RS 3000MOT · Traditional | Rad-Source, Inc. | 03/30/1998SE |
| K963497 | Gammacell 3000 Elan, Version 1.0 and Gammacell 1000 Elite, Version 1.0MOT · Traditional | Nordion International, Inc. | 11/08/1996SE |
| K952291 | Gammacell 3000 ElanMOT · Traditional | Nordion International, Inc. | 08/25/1995SE |
More from Nordion International, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K201042 | Probeat-CrLHN · Traditional | 07/13/2020SE |
| K191801 | Probeat-CrLHN · Traditional | 09/13/2019SE |
| K163505 | Arietta PrecisionIYN · Traditional | 05/30/2017SE |
| K162902 | ARIETTA Prologue Diagnostic Ultrasound system and TransducersIYN · Traditional | 12/15/2016SE |
| K162583 | Aloka Lisendo 880IYN · Traditional | 11/17/2016SE |
| K161163 | PROBEAT-V Proton Beam Therapy System with X-ray Limiting AccessoryLHN · Traditional | 07/13/2016SE |
| K060834 | Probeat with MGCSLHN · Special | 04/19/2006SE |
Questions and answers
When was Sangray cleared by the FDA?
Sangray (K172087) received a 510(k) decision of Substantially Equivalent on October 27, 2017, 108 days after the submission was received.
What is the product code of K172087?
The FDA product code is MOT – Irradiator, Blood To Prevent Graft Versus Host Disease, a Unclassified device.