IWIClass II
Source, Isotope, Sealed, Gold, Titanium, Platinum
Radiology · 21 CFR 892.5730
MDR events8All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances6All time
Recent MDR events
8 adverse event reports on file
- IODINE I125 SEEDS, IODINE (125 I)Nov 20, 2015MalfunctionGe Healthcare2915056-2015-00005
- RAPIDSTRAND IODINE I125 SEEDS, IODINE (125 I)Nov 20, 2013DeathGe Healthcare2915056-2013-00084
- RAPIDSTRAND RXOct 18, 2013MalfunctionGe Healthcare2915056-2013-00063
- IODINE I125 SEEDSJun 23, 2000InjuryNycomed Amersham Imaging2915056-2000-00001
- I-125 SEEDSSep 30, 1998MalfunctionNycomed Amersham2915056-1998-00002
- I-125 SEEDOct 21, 1997Malfunction*1416947-1997-03871
- I-125 SEEDOct 21, 1997Malfunction*1416947-1997-03870
- HICKMAN SUBCUTANEOUS PORTNov 20, 1992InjuryDavol2834
Event type breakdown
Malfunction5
Injury2
Death1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
6 clearances for this product code
- Ml Strategies, Inc.Jul 2, 1998
K973363 · NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633
- Medi-Physics Inc. Dba Nycomed Amersham ImagingSep 2, 1994
K940632 · I-125 RAPID STRAND
- Best IndustriesAug 9, 1991
K912170 · RADIOACTIVE IODINE-125 SOURCES
- Cis-Us, Inc.Apr 14, 1989
K882449 · CESIUM 137 SOURCE, MODEL CSM-40
- Theragenics Corp.Dec 22, 1987
K874787 · MODIFIED PALLADIUM SEED MODEL 100
- Nuclear Medicine, Inc.Jan 14, 1986
K852542 · PALLADIUM SEED MODEL 100