Atlas FDA

MOT

16 FDA 510(k) clearances · Product code

108 daysmedian time to decision
1296 days90th percentile
16clearances measured

FDA profile

Official device name
Irradiator, Blood To Prevent Graft Versus Host Disease
Device class
Unclassified
Medical specialty
Unknown
Adverse events (MAUDE)
1996: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
RadGil2 (K201177)R3 X-Ray L.L.C2020-08-17
Raycell MK1 (K181737)Best Theratronics Limited2019-01-02
SANGRAY (K172087)Hitachi , Ltd.2017-10-27
Raycell Mk2 (K161324)Best Theratronics Limited2016-08-12
RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 (K082921)Rad Source Technologies, Inc.2009-02-17
RAYCELL X-RAY BLOOD IRRADIATOR (K051065)Mds Nordion2005-05-26
GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN (K050963)Mds Nordion2005-05-20
RAYCELL (K032684)Mds Nordion2003-09-26
SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000 (K974210)Rad-Source, Inc.1998-03-30
GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0 (K963497)Nordion International, Inc.1996-11-08
GAMMACELL 3000 ELAN (K952291)Nordion International, Inc.1995-08-25
MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS (K915766)J. L. Shepherd and Assoc.1995-07-12
MODEL 143 SERIES BLOOD PRODUCT IRRADIATORS (K915767)J. L. Shepherd and Assoc.1995-07-12
IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C (K865027)Cis-Us, Inc.1987-02-26
IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C (K851828)Syncor Intl. Corp.1985-09-19
MODEL GAMMACELL 1000 (K837346)Atomic Energy of Canada1983-06-24

Track MOT automatically

Every clearance here is in the API, with alerts when new ones post.