KXK · Class II · 21 CFR 892.5730

FDA Product Code KXK: Source, Brachytherapy, Radionuclide

Leading manufacturers include Worldwide Medical Technologies, LLC, Implant Sciences Corp. and Cp Medical.

151
Total
151
Cleared
131d
Avg days
1980
Since
151 devices
73–96 of 151
Cleared Jun 10, 2003
SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000
K021360
Med-Tec,Inc.
Radiology · 406d
Cleared Jun 09, 2003
READI-STRAND, MODEL PSSTRAND
K022705
Worldwide Medical Technologies, LLC
Radiology · 299d
Cleared May 21, 2003
VARISEED 7.1
K030534
Varian Medical Systems
Radiology · 90d
Cleared May 06, 2003
READI-LOAD SYSTEM, MODEL PSS 1820RL
K022389
Worldwide Medical Technologies, LLC
Radiology · 287d
Cleared Apr 10, 2003
I-125 RAPID STRAND, MODEL 7000
K030594
Amersham Health
Radiology · 44d
Cleared Apr 07, 2003
SEED LINK
K023073
Implant Sciences Corp.
Radiology · 203d
Cleared Mar 28, 2003
SEEDLINKS, MODELS 70301, 70302, 70303
K023210
Sourcetech Medical, LLC
Radiology · 183d
Cleared Mar 28, 2003
LAWRENCE CSERION, MODEL CS-1
K030162
Isoray, Inc.
Radiology · 71d
Cleared Mar 17, 2003
ALTON PT STEPPER
K024183
Alton Design, LLC
Radiology · 88d
Cleared Mar 12, 2003
GAMMAMED 212 AND 232 SOURCE ASSEMBLY
K030745
Varian Medical Systems
Radiology · 2d
Cleared Mar 11, 2003
OPTIDOS
K010705
Ptw-New York Corp.
Radiology · 732d
Cleared Dec 17, 2002
ISOROD PD-103 IMPLANT, MODEL ATI-PD-103
K020683
Ati Medical, Inc.
Radiology · 288d
Cleared Dec 04, 2002
I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE
K023242
Implant Sciences Corp.
Radiology · 65d
Cleared Jul 29, 2002
READI-STRAND
K020337
Worldwide Medical Technologies, LLC
Radiology · 178d
Cleared Jul 13, 2002
SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL
K021311
Cp Medical
Radiology · 79d
Cleared May 20, 2002
ISOSEEDS I-125
K021343
Bebig Isotopen-Und Medizintechnik GmbH
Radiology · 21d
Cleared Feb 22, 2002
CP-SLEEVE
K013975
Cp Medical
Radiology · 81d
Cleared Jan 24, 2002
MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS
K013964
Cp Medical
Radiology · 52d
Cleared Dec 05, 2001
GENETRA
K013660
Radiomed Corporation
Radiology · 29d
Cleared Sep 04, 2001
ACCU-SPACE ABSORBABLE SEEDING SPACERS
K010621
Cp Medical
Radiology · 187d
Cleared Aug 31, 2001
MBI PD-103 SL
K011427
Mills Biopharmaceuticals, Inc.
Radiology · 115d
Cleared Jul 12, 2001
INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S
K011155
Ibt, Inc.
Radiology · 87d
Cleared Jul 10, 2001
ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125
K011205
Isoaid
Radiology · 82d
Cleared Jun 25, 2001
BRACHYSEED PD-103 MODELS #PD1
K011119
Draximage, Inc.
Radiology · 74d