FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
FCD
Barium Enema Kit
1
Product Code
ITZ
Assembly, Tube Housing, X-Ray, Therapeutic
2
Product Code
IWA
Source, Wire, Iridium, Radioactive
2
Product Code
IWB
System, Radiation Therapy, Radionuclide
2
Product Code
IWD
Device, Beam Limiting, Teletherapy, Radionuclide
2
Product Code
IWE
Monitor, Patient Position, Light-Beam
1
Product Code
IWF
Needle, Isotope, Gold, Titanium, Platinum
2
Product Code
IWG
Seed, Isotope, Gold, Titanium, Platinum
2
Product Code
IWH
Source, Teletherapy, Radionuclide
1
Product Code
IWI
Source, Isotope, Sealed, Gold, Titanium, Platinum
2
Product Code
IWJ
System, Applicator, Radionuclide, Manual
1
Product Code
IWK
Cyclotron, Medical
2
Product Code
IWL
System, Radiation Therapy, Neutron, Medical
2
Product Code
IWM
Synchrotron, Medical
2
Product Code
IXI
Block, Beam-Shaping, Radiation Therapy
2
Product Code
IYC
Generator, Orthovoltage, Therapeutic X-Ray
2
Product Code
IYD
Generator, Low Voltage, Therapeutic X-Ray
2
Product Code
IYE
Accelerator, Linear, Medical
2
Product Code
IYG
Betatron, Medical
2
Product Code
IYH
Generator, Dermatological (Grenz Ray), Therapeutic X-Ray
2
Product Code
IYI
Collimator, Orthovoltage, Therapeutic X-Ray
2
Product Code
IYJ
Collimator, Low Voltage, Therapeutic X-Ray
2
Product Code
IYK
Collimator, High Voltage, Therapeutic X-Ray
2
Product Code
IYL
Collimator, Dermatological, Therapeutic X-Ray
2
Product Code
JAD
System, Therapeutic, X-Ray
2
Product Code
JAE
Microtron, Medical
2
Product Code
JAI
Couch, Radiation Therapy, Powered
2
Product Code
JAQ
System, Applicator, Radionuclide, Remote-Controlled
2
Product Code
KPQ
System, Simulation, Radiation Therapy
2
Product Code
KPZ
Generator, High Voltage, X-Ray, Therapeutic
2
Product Code
KQA
Device, Beam Limiting, X-Ray, Therapeutic
2
Product Code
KXK
Source, Brachytherapy, Radionuclide
2
Product Code
K
22
3465
RadianceTx Radionuclide Brachytherapy Source
2
Cleared 510(K)
K
22
1539
GammaTile
2
Cleared 510(K)
K
20
2267
Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles
2
Cleared 510(K)
K
19
3602
LV Liberty Vision Model 1 90Yttrium Brachytherapy Source
2
Cleared 510(K)
K
19
0839
GammaTile
2
Cleared 510(K)
K
19
1324
CivaDerm
2
Cleared 510(K)
K
19
0296
GammaTile
2
Cleared 510(K)
K
18
0515
GammaTile
2
Cleared 510(K)
K
17
1487
Sirius MRI Marker NS
2
Cleared 510(K)
K
16
3572
LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source
2
Cleared 510(K)
K
16
3206
SMD-Sr90-DA Radionuclide Brachytherapy Source
2
Cleared 510(K)
K
16
2573
Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source
2
Cleared 510(K)
K
16
1396
SPEC Model M23
2
Cleared 510(K)
K
16
1395
SPEC Model M13
2
Cleared 510(K)
K
15
0895
SPEC Model M16
2
Cleared 510(K)
K
15
0636
VariSeed 9.0
2
Cleared 510(K)
K
14
2701
SMD Sr90-1 Radionuclide Brachytherapy Source
2
Cleared 510(K)
K
14
1701
I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE]
2
Cleared 510(K)
K
14
2668
Lesion-Loc Iodine I-125 Seed/Needle
2
Cleared 510(K)
K
14
1038
ANT MODEL 1
2
Cleared 510(K)
K
14
0490
CIVA SHEET PD-103
2
Cleared 510(K)
K
14
0849
ISOSEED
2
Cleared 510(K)
K
14
0856
BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS
2
Cleared 510(K)
K
13
2969
SPEC MODEL M15
2
Cleared 510(K)
K
13
2996
CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS
2
Cleared 510(K)
K
13
1689
MRI MARKER
2
Cleared 510(K)
K
12
2704
BEST LOCALIZATION NEEDLE WITH I-125 SEED
2
Cleared 510(K)
K
12
2764
RAPID STRAND RX
2
Cleared 510(K)
K
11
3210
ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT
2
Cleared 510(K)
K
12
0859
PRE-LOADED GOLD VISICOIL CK MARKER
2
Cleared 510(K)
K
11
1979
RADIOACTIVE SEED LOCALIZATION NEEDLE
2
Cleared 510(K)
K
11
1931
GLIASITE RTS
2
Cleared 510(K)
K
10
2811
AOS ORION IR-192 SOURCE CABLE
2
Cleared 510(K)
K
10
3449
BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS
2
Cleared 510(K)
K
10
3319
I-SEED
2
Cleared 510(K)
K
10
0847
SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30
2
Cleared 510(K)
K
09
3663
RADIONUCLIDE BRACHYTHERAPY SOURCE
2
Cleared 510(K)
K
09
2522
ACU007S
2
Cleared 510(K)
K
09
1117
ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA
2
Cleared 510(K)
K
09
2458
PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2
2
Cleared 510(K)
K
09
2136
PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5
2
Cleared 510(K)
K
09
0366
SPEC MODEL M-31
2
Cleared 510(K)
K
08
3274
WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER
2
Cleared 510(K)
K
08
2159
CIVASTRING PD-103
2
Cleared 510(K)
K
07
2296
POIINT OF CARE STRANDING SYSTEM, MODE 1004-00
2
Cleared 510(K)
K
07
1550
PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS
2
Cleared 510(K)
K
06
2825
AOS MARKER SEEDS
2
Cleared 510(K)
K
07
0468
IMPLANT SCIENCES CORP. MODEL HDR 4454
2
Cleared 510(K)
K
06
2214
BRACHYSCIENCES STRANDPORT
2
Cleared 510(K)
K
06
3177
RAPID STRAND RX
2
Cleared 510(K)
K
06
2384
CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE
2
Cleared 510(K)
K
06
1638
BEST STRAND AND BEST SPACER
2
Cleared 510(K)
K
06
0679
SURTRAK IMPLANTATION KIT
2
Cleared 510(K)
K
06
0636
PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE
2
Cleared 510(K)
K
05
3595
CURAY CUSTOM SEED ARRAY
2
Cleared 510(K)
K
05
2024
NSTRAND IMPLANTATION KIT
2
Cleared 510(K)
K
04
3246
BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS
2
Cleared 510(K)
K
04
3596
THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06
2
Cleared 510(K)
K
04
3336
OPTISTRAND, MODEL 1032S
2
Cleared 510(K)
K
04
2864
IMPLANT SCIENCES CORP, MODEL HDR-4140
2
Cleared 510(K)
K
04
3117
BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER
2
Cleared 510(K)
K
04
2786
BEST MODEL # 81-01 SERIES IR-192 SOURCES
2
Cleared 510(K)
K
04
0766
OPTISOURCE, MODEL 1032P
2
Cleared 510(K)
K
04
1702
EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.)
2
Cleared 510(K)
K
04
1576
SOURCELINK
2
Cleared 510(K)
K
04
0339
BRACHYTHERAPY STRAND DEVICE
2
Cleared 510(K)
K
03
3770
ISOAID ADVANTAGE PD-103, MODEL IAPD-103A
2
Cleared 510(K)
K
03
4062
CP SLEEVE AND RIVER SLEEVE
2
Cleared 510(K)
K
03
3781
BEBIG ISOSEED I-125
2
Cleared 510(K)
K
02
3179
READI-STRAND, MODEL PSSTRAND
2
Cleared 510(K)
K
02
1360
SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000
2
Cleared 510(K)
K
02
2705
READI-STRAND, MODEL PSSTRAND
2
Cleared 510(K)
K
03
0534
VARISEED 7.1
2
Cleared 510(K)
K
02
2389
READI-LOAD SYSTEM, MODEL PSS 1820RL
2
Cleared 510(K)
K
03
0594
I-125 RAPID STRAND, MODEL 7000
2
Cleared 510(K)
K
02
3073
SEED LINK
2
Cleared 510(K)
K
03
0162
LAWRENCE CSERION, MODEL CS-1
2
Cleared 510(K)
K
02
3210
SEEDLINKS, MODELS 70301, 70302, 70303
2
Cleared 510(K)
K
02
4183
ALTON PT STEPPER
2
Cleared 510(K)
K
03
0745
GAMMAMED 212 AND 232 SOURCE ASSEMBLY
2
Cleared 510(K)
K
01
0705
OPTIDOS
2
Cleared 510(K)
K
02
0683
ISOROD PD-103 IMPLANT, MODEL ATI-PD-103
2
Cleared 510(K)
K
02
3242
I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE
2
Cleared 510(K)
K
02
0337
READI-STRAND; MODEL PSSTRAND
2
Cleared 510(K)
K
02
1311
SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL
2
Cleared 510(K)
K
02
1343
ISOSEEDS I-125
2
Cleared 510(K)
K
01
3975
CP-SLEEVE
2
Cleared 510(K)
K
01
3964
MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS
2
Cleared 510(K)
K
01
3660
GENETRA
2
Cleared 510(K)
K
01
0621
ACCU-SPACE ABSORBABLE SEEDING SPACERS
2
Cleared 510(K)
K
01
1427
MBI PD-103 SL; MBI PD-103 SH
2
Cleared 510(K)
K
01
1155
INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S
2
Cleared 510(K)
K
01
1205
ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125
2
Cleared 510(K)
K
01
1119
BRACHYSEED PD-103 MODELS #PD1
2
Cleared 510(K)
K
01
0283
THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200
2
Cleared 510(K)
K
00
3206
GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005
2
Cleared 510(K)
K
01
0821
ECHOSEED/IODINE-125 SEEDS, MODEL 6733
2
Cleared 510(K)
K
00
2429
SELECT SEED I-125
2
Cleared 510(K)
K
00
1070
RADIOMED SOURCE
2
Cleared 510(K)
K
00
2446
RE-ENTRANT CHAMBER, MODEL 1008 OR 44D
2
Cleared 510(K)
K
00
1366
PROSTEC 125I BRANCHYTHERAPY SNAPSEED
2
Cleared 510(K)
K
00
1765
LOOK COLLAGEN SPACERS, MODEL 1514B
2
Cleared 510(K)
K
00
0475
BRACHYSEED
2
Cleared 510(K)
K
99
4018
PHARMASEED, MODEL BT-125-3
2
Cleared 510(K)
K
99
4016
PHARMASEED, MODEL BT-103-3
2
Cleared 510(K)
K
99
3701
PHARMASEED, MODEL BT-125-2
2
Cleared 510(K)
K
99
3700
PHARMASEED, MODEL BT-103-2
2
Cleared 510(K)
K
99
3552
ISOSEED PD-103
2
Cleared 510(K)
K
99
4317
I-PLANT, MODEL 3500
2
Cleared 510(K)
K
99
1881
125-IMPLANT SEEDS, MODEL STM1250
2
Cleared 510(K)
K
99
3280
PROSTEC 125I BRACHYTHERAPY SEEDS
2
Cleared 510(K)
K
99
1571
10 CURIE IRDIUM 192, CSN00100-192
2
Cleared 510(K)
K
99
2007
PHARMASEED, MODEL BT-103-1
2
Cleared 510(K)
K
99
2008
PHARMASEED, MODEL BT-125-1
2
Cleared 510(K)
K
99
1344
WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS
2
Cleared 510(K)
K
99
1280
125 IMPLANT SEEDS, MODEL STM1251
2
Cleared 510(K)
K
99
2262
INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM
2
Cleared 510(K)
K
99
2963
I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401
2
Cleared 510(K)
K
99
1526
ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501
2
Cleared 510(K)
K
98
4235
INTERSOURCE 125, MODEL 1251L
2
Cleared 510(K)
K
99
0193
IODINE BRACHYTHERAPY SEEDS, MODEL 3000
2
Cleared 510(K)
K
98
2226
UROMED BRACHYTHERAPHY IODINE-125 SOURCES
2
Cleared 510(K)
K
98
4446
`BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH
2
Cleared 510(K)
K
97
3328
INTERSOURCE
2
Cleared 510(K)
K
97
2271
NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A
2
Cleared 510(K)
K
96
4647
NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE
2
Cleared 510(K)
K
94
5983
BEBIG INACTIVE OPHTHALMIC APPLICATORS FOR IODINE 125 SEEDS
2
Cleared 510(K)
K
93
6086
STERILE VIDEO CAMERA COVER AND DRAPE
2
Cleared 510(K)
K
93
1393
BEBIG PLAQUES RUM101-RUM114
2
Cleared 510(K)
K
92
3697
RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U
2
Cleared 510(K)
K
93
2242
RADIOACTIVE SAMARIUM 145 SEEDS/SOURCES #2341-2345
2
Cleared 510(K)
K
93
0570
RADIOACTIVE PALLADIUM 103 SEEDS/SOURCES
2
Cleared 510(K)
K
92
4261
RADIOACTIVE CESIUM-131 SEEDS/SOURCES
2
Cleared 510(K)
K
92
0880
BRAINSCAN BRACHYTHERAPY MODULE
2
Cleared 510(K)
K
92
3130
IR-192 IMPLANT -- MODIFICATION
2
Cleared 510(K)
K
91
4825
1-125 ENDOSEED
2
Cleared 510(K)
K
91
5156
I-125 SEEDS CODE: 6702
2
Cleared 510(K)
K
91
4281
I-125 SEEDS, CODE: 6711
2
Cleared 510(K)
K
91
4268
I-125 SEEDS IN CARRIER, CODE: 6720
2
Cleared 510(K)
K
91
0710
RADIOACTIVE SEEDS
2
Cleared 510(K)
K
91
1775
OMNICATH IMPLANTED CATHETER AND DEPOT
2
Cleared 510(K)
K
90
2488
MODIFIED CASS SYSTEM
2
Cleared 510(K)
K
90
3465
IR-192 IMPLANT
2
Cleared 510(K)
K
90
2622
MANAN PROSTATE SEEDING NEEDLE
2
Cleared 510(K)
K
89
6197
COLAB COCATH(TM) IMPLANTED CATHETER AND DEPOT
2
Cleared 510(K)
K
85
2023
CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41
2
Cleared 510(K)
K
85
0433
CESIUM 137 ENDOMETRIAL SOURCE
2
Cleared 510(K)
K
85
0434
CS137 SEALED SOURCES
2
Cleared 510(K)
K
80
1748
3M I-125 SEEDS IN ABSORBABLE CARRIER
2
Cleared 510(K)
LHN
System, Radiation Therapy, Charged-Particle, Medical
2
Product Code
MUJ
System, Planning, Radiation Therapy Treatment
2
Product Code
MWW
Accessory - Film Dosimetry System
2
Product Code
NMP
Needle, Isotope, Reprocessed
2
Product Code
NZT
Dosimeter, Ionizing Radiation, Implanted
2
Product Code
OIN
Prostate Seeding Kit
2
Product Code
ONL
Conformal Brachytherapy Source
2
Product Code
OVB
Hydrogel Spacer
2
Product Code
PCT
Prostate Immobilizer Rectal Balloon
2
Product Code
RGC
X-Ray Field Indicator Light (Laser)
1
Product Code
Subpart G—Miscellaneous Devices
CFR Sub-Part
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 4 July 2025 at 11:05 pm
RA
/
subpart-f—therapeutic-devices
/
KXK
/
K020683
View Source
ISOROD PD-103 IMPLANT, MODEL ATI-PD-103
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K020683
510(k) Type
Traditional
Applicant
ATI MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/17/2002
Days to Decision
288 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
Miscellaneous
Subpart B—Diagnostic Devices
Subpart C—Obstetrical and Gynecological Monitoring Devices
Subpart F—Therapeutic Devices
FCD
Barium Enema Kit
ITZ
Assembly, Tube Housing, X-Ray, Therapeutic
IWA
Source, Wire, Iridium, Radioactive
IWB
System, Radiation Therapy, Radionuclide
IWD
Device, Beam Limiting, Teletherapy, Radionuclide
IWE
Monitor, Patient Position, Light-Beam
IWF
Needle, Isotope, Gold, Titanium, Platinum
IWG
Seed, Isotope, Gold, Titanium, Platinum
IWH
Source, Teletherapy, Radionuclide
IWI
Source, Isotope, Sealed, Gold, Titanium, Platinum
IWJ
System, Applicator, Radionuclide, Manual
IWK
Cyclotron, Medical
IWL
System, Radiation Therapy, Neutron, Medical
IWM
Synchrotron, Medical
IXI
Block, Beam-Shaping, Radiation Therapy
IYC
Generator, Orthovoltage, Therapeutic X-Ray
IYD
Generator, Low Voltage, Therapeutic X-Ray
IYE
Accelerator, Linear, Medical
IYG
Betatron, Medical
IYH
Generator, Dermatological (Grenz Ray), Therapeutic X-Ray
IYI
Collimator, Orthovoltage, Therapeutic X-Ray
IYJ
Collimator, Low Voltage, Therapeutic X-Ray
IYK
Collimator, High Voltage, Therapeutic X-Ray
IYL
Collimator, Dermatological, Therapeutic X-Ray
JAD
System, Therapeutic, X-Ray
JAE
Microtron, Medical
JAI
Couch, Radiation Therapy, Powered
JAQ
System, Applicator, Radionuclide, Remote-Controlled
KPQ
System, Simulation, Radiation Therapy
KPZ
Generator, High Voltage, X-Ray, Therapeutic
KQA
Device, Beam Limiting, X-Ray, Therapeutic
KXK
Source, Brachytherapy, Radionuclide
K
22
3465
RadianceTx Radionuclide Brachytherapy Source
K
22
1539
GammaTile
K
20
2267
Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles
K
19
3602
LV Liberty Vision Model 1 90Yttrium Brachytherapy Source
K
19
0839
GammaTile
K
19
1324
CivaDerm
K
19
0296
GammaTile
K
18
0515
GammaTile
K
17
1487
Sirius MRI Marker NS
K
16
3572
LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source
K
16
3206
SMD-Sr90-DA Radionuclide Brachytherapy Source
K
16
2573
Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source
K
16
1396
SPEC Model M23
K
16
1395
SPEC Model M13
K
15
0895
SPEC Model M16
K
15
0636
VariSeed 9.0
K
14
2701
SMD Sr90-1 Radionuclide Brachytherapy Source
K
14
1701
I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE]
K
14
2668
Lesion-Loc Iodine I-125 Seed/Needle
K
14
1038
ANT MODEL 1
K
14
0490
CIVA SHEET PD-103
K
14
0849
ISOSEED
K
14
0856
BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS
K
13
2969
SPEC MODEL M15
K
13
2996
CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS
K
13
1689
MRI MARKER
K
12
2704
BEST LOCALIZATION NEEDLE WITH I-125 SEED
K
12
2764
RAPID STRAND RX
K
11
3210
ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT
K
12
0859
PRE-LOADED GOLD VISICOIL CK MARKER
K
11
1979
RADIOACTIVE SEED LOCALIZATION NEEDLE
K
11
1931
GLIASITE RTS
K
10
2811
AOS ORION IR-192 SOURCE CABLE
K
10
3449
BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS
K
10
3319
I-SEED
K
10
0847
SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30
K
09
3663
RADIONUCLIDE BRACHYTHERAPY SOURCE
K
09
2522
ACU007S
K
09
1117
ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA
K
09
2458
PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2
K
09
2136
PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5
K
09
0366
SPEC MODEL M-31
K
08
3274
WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER
K
08
2159
CIVASTRING PD-103
K
07
2296
POIINT OF CARE STRANDING SYSTEM, MODE 1004-00
K
07
1550
PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS
K
06
2825
AOS MARKER SEEDS
K
07
0468
IMPLANT SCIENCES CORP. MODEL HDR 4454
K
06
2214
BRACHYSCIENCES STRANDPORT
K
06
3177
RAPID STRAND RX
K
06
2384
CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE
K
06
1638
BEST STRAND AND BEST SPACER
K
06
0679
SURTRAK IMPLANTATION KIT
K
06
0636
PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE
K
05
3595
CURAY CUSTOM SEED ARRAY
K
05
2024
NSTRAND IMPLANTATION KIT
K
04
3246
BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS
K
04
3596
THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06
K
04
3336
OPTISTRAND, MODEL 1032S
K
04
2864
IMPLANT SCIENCES CORP, MODEL HDR-4140
K
04
3117
BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER
K
04
2786
BEST MODEL # 81-01 SERIES IR-192 SOURCES
K
04
0766
OPTISOURCE, MODEL 1032P
K
04
1702
EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.)
K
04
1576
SOURCELINK
K
04
0339
BRACHYTHERAPY STRAND DEVICE
K
03
3770
ISOAID ADVANTAGE PD-103, MODEL IAPD-103A
K
03
4062
CP SLEEVE AND RIVER SLEEVE
K
03
3781
BEBIG ISOSEED I-125
K
02
3179
READI-STRAND, MODEL PSSTRAND
K
02
1360
SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000
K
02
2705
READI-STRAND, MODEL PSSTRAND
K
03
0534
VARISEED 7.1
K
02
2389
READI-LOAD SYSTEM, MODEL PSS 1820RL
K
03
0594
I-125 RAPID STRAND, MODEL 7000
K
02
3073
SEED LINK
K
03
0162
LAWRENCE CSERION, MODEL CS-1
K
02
3210
SEEDLINKS, MODELS 70301, 70302, 70303
K
02
4183
ALTON PT STEPPER
K
03
0745
GAMMAMED 212 AND 232 SOURCE ASSEMBLY
K
01
0705
OPTIDOS
K
02
0683
ISOROD PD-103 IMPLANT, MODEL ATI-PD-103
K
02
3242
I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE
K
02
0337
READI-STRAND; MODEL PSSTRAND
K
02
1311
SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL
K
02
1343
ISOSEEDS I-125
K
01
3975
CP-SLEEVE
K
01
3964
MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS
K
01
3660
GENETRA
K
01
0621
ACCU-SPACE ABSORBABLE SEEDING SPACERS
K
01
1427
MBI PD-103 SL; MBI PD-103 SH
K
01
1155
INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S
K
01
1205
ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125
K
01
1119
BRACHYSEED PD-103 MODELS #PD1
K
01
0283
THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200
K
00
3206
GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005
K
01
0821
ECHOSEED/IODINE-125 SEEDS, MODEL 6733
K
00
2429
SELECT SEED I-125
K
00
1070
RADIOMED SOURCE
K
00
2446
RE-ENTRANT CHAMBER, MODEL 1008 OR 44D
K
00
1366
PROSTEC 125I BRANCHYTHERAPY SNAPSEED
K
00
1765
LOOK COLLAGEN SPACERS, MODEL 1514B
K
00
0475
BRACHYSEED
K
99
4018
PHARMASEED, MODEL BT-125-3
K
99
4016
PHARMASEED, MODEL BT-103-3
K
99
3701
PHARMASEED, MODEL BT-125-2
K
99
3700
PHARMASEED, MODEL BT-103-2
K
99
3552
ISOSEED PD-103
K
99
4317
I-PLANT, MODEL 3500
K
99
1881
125-IMPLANT SEEDS, MODEL STM1250
K
99
3280
PROSTEC 125I BRACHYTHERAPY SEEDS
K
99
1571
10 CURIE IRDIUM 192, CSN00100-192
K
99
2007
PHARMASEED, MODEL BT-103-1
K
99
2008
PHARMASEED, MODEL BT-125-1
K
99
1344
WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS
K
99
1280
125 IMPLANT SEEDS, MODEL STM1251
K
99
2262
INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM
K
99
2963
I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401
K
99
1526
ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501
K
98
4235
INTERSOURCE 125, MODEL 1251L
K
99
0193
IODINE BRACHYTHERAPY SEEDS, MODEL 3000
K
98
2226
UROMED BRACHYTHERAPHY IODINE-125 SOURCES
K
98
4446
`BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH
K
97
3328
INTERSOURCE
K
97
2271
NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A
K
96
4647
NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE
K
94
5983
BEBIG INACTIVE OPHTHALMIC APPLICATORS FOR IODINE 125 SEEDS
K
93
6086
STERILE VIDEO CAMERA COVER AND DRAPE
K
93
1393
BEBIG PLAQUES RUM101-RUM114
K
92
3697
RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U
K
93
2242
RADIOACTIVE SAMARIUM 145 SEEDS/SOURCES #2341-2345
K
93
0570
RADIOACTIVE PALLADIUM 103 SEEDS/SOURCES
K
92
4261
RADIOACTIVE CESIUM-131 SEEDS/SOURCES
K
92
0880
BRAINSCAN BRACHYTHERAPY MODULE
K
92
3130
IR-192 IMPLANT -- MODIFICATION
K
91
4825
1-125 ENDOSEED
K
91
5156
I-125 SEEDS CODE: 6702
K
91
4281
I-125 SEEDS, CODE: 6711
K
91
4268
I-125 SEEDS IN CARRIER, CODE: 6720
K
91
0710
RADIOACTIVE SEEDS
K
91
1775
OMNICATH IMPLANTED CATHETER AND DEPOT
K
90
2488
MODIFIED CASS SYSTEM
K
90
3465
IR-192 IMPLANT
K
90
2622
MANAN PROSTATE SEEDING NEEDLE
K
89
6197
COLAB COCATH(TM) IMPLANTED CATHETER AND DEPOT
K
85
2023
CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41
K
85
0433
CESIUM 137 ENDOMETRIAL SOURCE
K
85
0434
CS137 SEALED SOURCES
K
80
1748
3M I-125 SEEDS IN ABSORBABLE CARRIER
LHN
System, Radiation Therapy, Charged-Particle, Medical
MUJ
System, Planning, Radiation Therapy Treatment
MWW
Accessory - Film Dosimetry System
NMP
Needle, Isotope, Reprocessed
NZT
Dosimeter, Ionizing Radiation, Implanted
OIN
Prostate Seeding Kit
ONL
Conformal Brachytherapy Source
OVB
Hydrogel Spacer
PCT
Prostate Immobilizer Rectal Balloon
RGC
X-Ray Field Indicator Light (Laser)
Subpart G—Miscellaneous Devices
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
RA
/
subpart-f—therapeutic-devices
/
KXK
/
K020683
View Source
ISOROD PD-103 IMPLANT, MODEL ATI-PD-103
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K020683
510(k) Type
Traditional
Applicant
ATI MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/17/2002
Days to Decision
288 days
Submission Type
Summary