Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- FCDBarium Enema Kit1Product Code
- ITZAssembly, Tube Housing, X-Ray, Therapeutic2Product Code
- IWASource, Wire, Iridium, Radioactive2Product Code
- IWBSystem, Radiation Therapy, Radionuclide2Product Code
- IWDDevice, Beam Limiting, Teletherapy, Radionuclide2Product Code
- IWEMonitor, Patient Position, Light-Beam1Product Code
- IWFNeedle, Isotope, Gold, Titanium, Platinum2Product Code
- IWGSeed, Isotope, Gold, Titanium, Platinum2Product Code
- IWHSource, Teletherapy, Radionuclide1Product Code
- IWISource, Isotope, Sealed, Gold, Titanium, Platinum2Product Code
- IWJSystem, Applicator, Radionuclide, Manual1Product Code
- IWKCyclotron, Medical2Product Code
- IWLSystem, Radiation Therapy, Neutron, Medical2Product Code
- IWMSynchrotron, Medical2Product Code
- IXIBlock, Beam-Shaping, Radiation Therapy2Product Code
- IYCGenerator, Orthovoltage, Therapeutic X-Ray2Product Code
- IYDGenerator, Low Voltage, Therapeutic X-Ray2Product Code
- IYEAccelerator, Linear, Medical2Product Code
- IYGBetatron, Medical2Product Code
- IYHGenerator, Dermatological (Grenz Ray), Therapeutic X-Ray2Product Code
- IYICollimator, Orthovoltage, Therapeutic X-Ray2Product Code
- IYJCollimator, Low Voltage, Therapeutic X-Ray2Product Code
- IYKCollimator, High Voltage, Therapeutic X-Ray2Product Code
- IYLCollimator, Dermatological, Therapeutic X-Ray2Product Code
- JADSystem, Therapeutic, X-Ray2Product Code
- JAEMicrotron, Medical2Product Code
- JAICouch, Radiation Therapy, Powered2Product Code
- JAQSystem, Applicator, Radionuclide, Remote-Controlled2Product Code
- KPQSystem, Simulation, Radiation Therapy2Product Code
- KPZGenerator, High Voltage, X-Ray, Therapeutic2Product Code
- KQADevice, Beam Limiting, X-Ray, Therapeutic2Product Code
- KXKSource, Brachytherapy, Radionuclide2Product Code
- K223465RadianceTx Radionuclide Brachytherapy Source2Cleared 510(K)
- K221539GammaTile2Cleared 510(K)
- K202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles2Cleared 510(K)
- K193602LV Liberty Vision Model 1 90Yttrium Brachytherapy Source2Cleared 510(K)
- K190839GammaTile2Cleared 510(K)
- K191324CivaDerm2Cleared 510(K)
- K190296GammaTile2Cleared 510(K)
- K180515GammaTile2Cleared 510(K)
- K171487Sirius MRI Marker NS2Cleared 510(K)
- K163572LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source2Cleared 510(K)
- K163206SMD-Sr90-DA Radionuclide Brachytherapy Source2Cleared 510(K)
- K162573Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source2Cleared 510(K)
- K161396SPEC Model M232Cleared 510(K)
- K161395SPEC Model M132Cleared 510(K)
- K150895SPEC Model M162Cleared 510(K)
- K150636VariSeed 9.02Cleared 510(K)
- K142701SMD Sr90-1 Radionuclide Brachytherapy Source2Cleared 510(K)
- K141701I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE]2Cleared 510(K)
- K142668Lesion-Loc Iodine I-125 Seed/Needle2Cleared 510(K)
- K141038ANT MODEL 12Cleared 510(K)
- K140490CIVA SHEET PD-1032Cleared 510(K)
- K140849ISOSEED2Cleared 510(K)
- K140856BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS2Cleared 510(K)
- K132969SPEC MODEL M152Cleared 510(K)
- K132996CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS2Cleared 510(K)
- K131689MRI MARKER2Cleared 510(K)
- K122704BEST LOCALIZATION NEEDLE WITH I-125 SEED2Cleared 510(K)
- K122764RAPID STRAND RX2Cleared 510(K)
- K113210ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT2Cleared 510(K)
- K120859PRE-LOADED GOLD VISICOIL CK MARKER2Cleared 510(K)
- K111979RADIOACTIVE SEED LOCALIZATION NEEDLE2Cleared 510(K)
- K111931GLIASITE RTS2Cleared 510(K)
- K102811AOS ORION IR-192 SOURCE CABLE2Cleared 510(K)
- K103449BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS2Cleared 510(K)
- K103319I-SEED2Cleared 510(K)
- K100847SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-302Cleared 510(K)
- K093663RADIONUCLIDE BRACHYTHERAPY SOURCE2Cleared 510(K)
- K092522ACU007S2Cleared 510(K)
- K091117ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA2Cleared 510(K)
- K092458PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-22Cleared 510(K)
- K092136PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-52Cleared 510(K)
- K090366SPEC MODEL M-312Cleared 510(K)
- K083274WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER2Cleared 510(K)
- K082159CIVASTRING PD-1032Cleared 510(K)
- K072296POIINT OF CARE STRANDING SYSTEM, MODE 1004-002Cleared 510(K)
- K071550PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS2Cleared 510(K)
- K062825AOS MARKER SEEDS2Cleared 510(K)
- K070468IMPLANT SCIENCES CORP. MODEL HDR 44542Cleared 510(K)
- K062214BRACHYSCIENCES STRANDPORT2Cleared 510(K)
- K063177RAPID STRAND RX2Cleared 510(K)
- K062384CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE2Cleared 510(K)
- K061638BEST STRAND AND BEST SPACER2Cleared 510(K)
- K060679SURTRAK IMPLANTATION KIT2Cleared 510(K)
- K060636PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE2Cleared 510(K)
- K053595CURAY CUSTOM SEED ARRAY2Cleared 510(K)
- K052024NSTRAND IMPLANTATION KIT2Cleared 510(K)
- K043246BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS2Cleared 510(K)
- K043596THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S062Cleared 510(K)
- K043336OPTISTRAND, MODEL 1032S2Cleared 510(K)
- K042864IMPLANT SCIENCES CORP, MODEL HDR-41402Cleared 510(K)
- K043117BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER2Cleared 510(K)
- K042786BEST MODEL # 81-01 SERIES IR-192 SOURCES2Cleared 510(K)
- K040766OPTISOURCE, MODEL 1032P2Cleared 510(K)
- K041702EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.)2Cleared 510(K)
- K041576SOURCELINK2Cleared 510(K)
- K040339BRACHYTHERAPY STRAND DEVICE2Cleared 510(K)
- K033770ISOAID ADVANTAGE PD-103, MODEL IAPD-103A2Cleared 510(K)
- K034062CP SLEEVE AND RIVER SLEEVE2Cleared 510(K)
- K033781BEBIG ISOSEED I-1252Cleared 510(K)
- K023179READI-STRAND, MODEL PSSTRAND2Cleared 510(K)
- K021360SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-10002Cleared 510(K)
- K022705READI-STRAND, MODEL PSSTRAND2Cleared 510(K)
- K030534VARISEED 7.12Cleared 510(K)
- K022389READI-LOAD SYSTEM, MODEL PSS 1820RL2Cleared 510(K)
- K030594I-125 RAPID STRAND, MODEL 70002Cleared 510(K)
- K023073SEED LINK2Cleared 510(K)
- K030162LAWRENCE CSERION, MODEL CS-12Cleared 510(K)
- K023210SEEDLINKS, MODELS 70301, 70302, 703032Cleared 510(K)
- K024183ALTON PT STEPPER2Cleared 510(K)
- K030745GAMMAMED 212 AND 232 SOURCE ASSEMBLY2Cleared 510(K)
- K010705OPTIDOS2Cleared 510(K)
- K020683ISOROD PD-103 IMPLANT, MODEL ATI-PD-1032Cleared 510(K)
- K023242I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE2Cleared 510(K)
- K020337READI-STRAND; MODEL PSSTRAND2Cleared 510(K)
- K021311SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL2Cleared 510(K)
- K021343ISOSEEDS I-1252Cleared 510(K)
- K013975CP-SLEEVE2Cleared 510(K)
- K013964MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS2Cleared 510(K)
- K013660GENETRA2Cleared 510(K)
- K010621ACCU-SPACE ABSORBABLE SEEDING SPACERS2Cleared 510(K)
- K011427MBI PD-103 SL; MBI PD-103 SH2Cleared 510(K)
- K011155INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S2Cleared 510(K)
- K011205ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-1252Cleared 510(K)
- K011119BRACHYSEED PD-103 MODELS #PD12Cleared 510(K)
- K010283THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 2002Cleared 510(K)
- K003206GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,90052Cleared 510(K)
- K010821ECHOSEED/IODINE-125 SEEDS, MODEL 67332Cleared 510(K)
- K002429SELECT SEED I-1252Cleared 510(K)
- K001070RADIOMED SOURCE2Cleared 510(K)
- K002446RE-ENTRANT CHAMBER, MODEL 1008 OR 44D2Cleared 510(K)
- K001366PROSTEC 125I BRANCHYTHERAPY SNAPSEED2Cleared 510(K)
- K001765LOOK COLLAGEN SPACERS, MODEL 1514B2Cleared 510(K)
- K000475BRACHYSEED2Cleared 510(K)
- K994018PHARMASEED, MODEL BT-125-32Cleared 510(K)
- K994016PHARMASEED, MODEL BT-103-32Cleared 510(K)
- K993701PHARMASEED, MODEL BT-125-22Cleared 510(K)
- K993700PHARMASEED, MODEL BT-103-22Cleared 510(K)
- K993552ISOSEED PD-1032Cleared 510(K)
- K994317I-PLANT, MODEL 35002Cleared 510(K)
- K991881125-IMPLANT SEEDS, MODEL STM12502Cleared 510(K)
- K993280PROSTEC 125I BRACHYTHERAPY SEEDS2Cleared 510(K)
- K99157110 CURIE IRDIUM 192, CSN00100-1922Cleared 510(K)
- K992007PHARMASEED, MODEL BT-103-12Cleared 510(K)
- K992008PHARMASEED, MODEL BT-125-12Cleared 510(K)
- K991344WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS2Cleared 510(K)
- K991280125 IMPLANT SEEDS, MODEL STM12512Cleared 510(K)
- K992262INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM2Cleared 510(K)
- K992963I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-04012Cleared 510(K)
- K991526ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-125012Cleared 510(K)
- K984235INTERSOURCE 125, MODEL 1251L2Cleared 510(K)
- K990193IODINE BRACHYTHERAPY SEEDS, MODEL 30002Cleared 510(K)
- K982226UROMED BRACHYTHERAPHY IODINE-125 SOURCES2Cleared 510(K)
- K984446`BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH2Cleared 510(K)
- K973328INTERSOURCE2Cleared 510(K)
- K972271NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A2Cleared 510(K)
- K964647NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE2Cleared 510(K)
- K945983BEBIG INACTIVE OPHTHALMIC APPLICATORS FOR IODINE 125 SEEDS2Cleared 510(K)
- K936086STERILE VIDEO CAMERA COVER AND DRAPE2Cleared 510(K)
- K931393BEBIG PLAQUES RUM101-RUM1142Cleared 510(K)
- K923697RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U2Cleared 510(K)
- K932242RADIOACTIVE SAMARIUM 145 SEEDS/SOURCES #2341-23452Cleared 510(K)
- K930570RADIOACTIVE PALLADIUM 103 SEEDS/SOURCES2Cleared 510(K)
- K924261RADIOACTIVE CESIUM-131 SEEDS/SOURCES2Cleared 510(K)
- K920880BRAINSCAN BRACHYTHERAPY MODULE2Cleared 510(K)
- K923130IR-192 IMPLANT -- MODIFICATION2Cleared 510(K)
- K9148251-125 ENDOSEED2Cleared 510(K)
- K915156I-125 SEEDS CODE: 67022Cleared 510(K)
- K914281I-125 SEEDS, CODE: 67112Cleared 510(K)
- K914268I-125 SEEDS IN CARRIER, CODE: 67202Cleared 510(K)
- K910710RADIOACTIVE SEEDS2Cleared 510(K)
- K911775OMNICATH IMPLANTED CATHETER AND DEPOT2Cleared 510(K)
- K902488MODIFIED CASS SYSTEM2Cleared 510(K)
- K903465IR-192 IMPLANT2Cleared 510(K)
- K902622MANAN PROSTATE SEEDING NEEDLE2Cleared 510(K)
- K896197COLAB COCATH(TM) IMPLANTED CATHETER AND DEPOT2Cleared 510(K)
- K852023CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-412Cleared 510(K)
- K850433CESIUM 137 ENDOMETRIAL SOURCE2Cleared 510(K)
- K850434CS137 SEALED SOURCES2Cleared 510(K)
- K8017483M I-125 SEEDS IN ABSORBABLE CARRIER2Cleared 510(K)
- LHNSystem, Radiation Therapy, Charged-Particle, Medical2Product Code
- MUJSystem, Planning, Radiation Therapy Treatment2Product Code
- MWWAccessory - Film Dosimetry System2Product Code
- NMPNeedle, Isotope, Reprocessed2Product Code
- NZTDosimeter, Ionizing Radiation, Implanted2Product Code
- OINProstate Seeding Kit2Product Code
- ONLConformal Brachytherapy Source2Product Code
- OVBHydrogel Spacer2Product Code
- PCTProstate Immobilizer Rectal Balloon2Product Code
- RGCX-Ray Field Indicator Light (Laser)1Product Code
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SPEC MODEL M-31
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K090366
- 510(k) Type
- Traditional
- Applicant
- SOURCE PRODUCTION & EQUIPMENT CO., INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/22/2009
- Days to Decision
- 68 days
- Submission Type
- Summary