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
- K251037Rectal Applicator2Cleared 510(K)
- K252884Guided Aarhus Applicator Set2Cleared 510(K)
- K250299CT/ MR Tandem and Ovoid Set2Cleared 510(K)
- K250289Intracavitary/Interstitial System2Cleared 510(K)
- K243939Titanium Flexible Geometry FSD Applicator Set (GM11013400)2Cleared 510(K)
- K241764Mould Probe MR Safe2Cleared 510(K)
- K242961Intraluminal Applicator Set2Cleared 510(K)
- K243045“BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)2Cleared 510(K)
- K241853Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve2Cleared 510(K)
- K241965Catheter Surface Flap Applicator Set (GM11011830)2Cleared 510(K)
- K241386Heyman Packing Applicator Set (GM11004580)2Cleared 510(K)
- K233628AOS Interstitial Templates, Needles, and Accessories2Cleared 510(K)
- K233626AOS Marker Seeds (SMG0242-025)2Cleared 510(K)
- K240495Flexible Fixation Device for Gynecological Applicators (GM11001960)2Cleared 510(K)
- K232623Universal Endometrial Applicator Set (GM11009840)2Cleared 510(K)
- K232949Kelowna GYN and Crook Prostate Templates2Cleared 510(K)
- K230155Mick Valencia Applicator Set2Cleared 510(K)
- K222775Aarhus Applicator Set2Cleared 510(K)
- K221797BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device2Cleared 510(K)
- K193240Universal Cylinder Applicator Family2Cleared 510(K)
- K201272Geneva2Cleared 510(K)
- K201279ASSISTO Universal Applicator Clamping Device2Cleared 510(K)
- K200221CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor2Cleared 510(K)
- K191580BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device2Cleared 510(K)
- K183332“BRAXX” Esophageal Brachytherapy Applicator2Cleared 510(K)
- K172533GM Implant Tubes, Length Cutting Gauge2Cleared 510(K)
- K181903BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device2Cleared 510(K)
- K172675Varian Cervical Sleeves2Cleared 510(K)
- K180069HDR MRI Lumen Marker2Cleared 510(K)
- K162499Best Instruminal Applicator2Cleared 510(K)
- K172611Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths2Cleared 510(K)
- K171631Standard Catheter Set2Cleared 510(K)
- K162533Kelowna GYN and Crook Prostate Templates2Cleared 510(K)
- K170203System, Applicator, Radionuclide, Remote Controlled2Cleared 510(K)
- K162615Mould Applicator Set2Cleared 510(K)
- K160815Interstitial Needles2Cleared 510(K)
- K162018Surface Applicator Set2Cleared 510(K)
- K160610Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set2Cleared 510(K)
- K161688Advanced Gynecological Applicator2Cleared 510(K)
- K160045Heyman Packing Applicator Set2Cleared 510(K)
- K161540Advanced Breast Template System2Cleared 510(K)
- K161576Esophagus Bougie Set2Cleared 510(K)
- K160516Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths2Cleared 510(K)
- K150979CT/MR Compatible M.A.C. Interstitial GYN Template2Cleared 510(K)
- K160021Varian Sterilization Boxes2Cleared 510(K)
- K151022Intraluminal Applicator Set2Cleared 510(K)
- K152018Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets2Cleared 510(K)
- K151657Shielded Applicator Set, Cervical Stop2Cleared 510(K)
- K1508393D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 902Cleared 510(K)
- K151272Henschke Titanium Applicator Set2Cleared 510(K)
- K142719E-App2Cleared 510(K)
- K142986SagiNova2Cleared 510(K)
- K142330Kobold Ring and Tandem Applicator Set2Cleared 510(K)
- K142439Martinez Prostate Template Set2Cleared 510(K)
- K141624PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 1132Cleared 510(K)
- K142597Vienna System2Cleared 510(K)
- K141490UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET2Cleared 510(K)
- K141336SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS2Cleared 510(K)
- K140803LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM2Cleared 510(K)
- K133922GENTLECARE AR APPLICATOR2Cleared 510(K)
- K130757KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET; KOBOLD LUER TRANSFER GUIDE TUBE SET2Cleared 510(K)
- K132889FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM)2Cleared 510(K)
- K132874LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM2Cleared 510(K)
- K132097BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY2Cleared 510(K)
- K123912KOBOLD FLETCHER TYPE APPLICATOR SET, KOBOLD HENSCHKE TYPE APPLICATOR SET2Cleared 510(K)
- K123941KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET2Cleared 510(K)
- K130251ESOPHAGUS BOUGIE SET2Cleared 510(K)
- K123815SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE2Cleared 510(K)
- K123442XOFT AXXENT CERVICAL APPLICATORS2Cleared 510(K)
- K122840CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 04072Cleared 510(K)
- K122236VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER2Cleared 510(K)
- K120993GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER2Cleared 510(K)
- K120731TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY2Cleared 510(K)
- K120344RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE2Cleared 510(K)
- K120341PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM2Cleared 510(K)
- K113766CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN2Cleared 510(K)
- K112420ONCENTRA PROSTATE 4.02Cleared 510(K)
- K111973VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET2Cleared 510(K)
- K103215CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT2Cleared 510(K)
- K101411SAVI PREPARATION DEVICE2Cleared 510(K)
- K092534ALATUS VAGINAL BALLOON PACKING SYSTEM2Cleared 510(K)
- K093291VARIAN INTERSTITIAL TITANIUM NEEDLES2Cleared 510(K)
- K092822CAPRI APPLICATOR2Cleared 510(K)
- K092804MICROSELECTRON HDR V2, MODEL 105.9992Cleared 510(K)
- K092405MAMMOSITE MULTI LUMEN2Cleared 510(K)
- K092323CONTURA CAVITY MAINTENANCE CATHETER2Cleared 510(K)
- K091230HDR PROSTATE TEMPLATE AND ACCESSORIES2Cleared 510(K)
- K091378MAMMOSITE II RADIATION THERAPY SYSTEM2Cleared 510(K)
- K091598LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS2Cleared 510(K)
- K091154UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330,2Cleared 510(K)
- K082530APPLICATORS FOR AFTERLOADING BRACHYTHERAPY2Cleared 510(K)
- K082653CENTERING INTRALUMINAL APPLICATOR2Cleared 510(K)
- K082264CONTURA LUMEN MARKER2Cleared 510(K)
- K081677SAVI APPLICATOR KIT2Cleared 510(K)
- K080934VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET2Cleared 510(K)
- K081179MAMMOSITE CAVITY EVALUATION DEVICE2Cleared 510(K)
- K081079CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY2Cleared 510(K)
- K080791CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-452Cleared 510(K)
- K080871TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS2Cleared 510(K)
- K080565MODIFICATION TO: SAVI APPLICATOR KIT2Cleared 510(K)
- K073107VALENCIA SKIN APPLICATOR SET, MODEL: 189.7012Cleared 510(K)
- K073133INTERSTITIAL NEEDLES2Cleared 510(K)
- K071381GAMMAMEDPLUS IX SERIES HDR AFTERLOADER2Cleared 510(K)
- K071467VARISOURCE IX HDR AFTERLOADER2Cleared 510(K)
- K062824AOS UNIVERSAL CONECTING GUIDE TUBE2Cleared 510(K)
- K062823AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES2Cleared 510(K)
- K062826AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS2Cleared 510(K)
- K071229SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY2Cleared 510(K)
- K070574FLEXITRON2Cleared 510(K)
- K070659BIOLUCENT APPLICATOR KIT2Cleared 510(K)
- K063815VARIAN ESOPHAGUS BOUGIE APPLICATOR2Cleared 510(K)
- K063382HDR CT COMPATIBLE SPLIT RING APPLICATOR2Cleared 510(K)
- K063381CT COMPATIBLE F/S/D APPLICATORS2Cleared 510(K)
- K062241ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR2Cleared 510(K)
- K062135ART SHIELDED BREAST APPLICATOR2Cleared 510(K)
- K062830BIOLUCENT APPLICATOR KIT2Cleared 510(K)
- K061354MICROSELECTRON V3, MODEL 106.9902Cleared 510(K)
- K061241BIOLUCENT APPLICATOR, MODEL RTA-XX2Cleared 510(K)
- K061582VARISOURCE 200 HDR AFTERLOADER2Cleared 510(K)
- K060299ART BRACHYTHERAPY APPLICATOR2Cleared 510(K)
- K052947SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE2Cleared 510(K)
- K060532HDR 1000 PLUS WELL CHAMBER, MODEL 900082Cleared 510(K)
- K051753ACCU-SOURCE2Cleared 510(K)
- K060349PROGUIDE NEEDLE SET2Cleared 510(K)
- K052228SMIT SLEEVE2Cleared 510(K)
- K052595CRC 15ULTRA2Cleared 510(K)
- K052351HDR IORT SHIELDED APPLICATOR2Cleared 510(K)
- K051423MICK HDR INTERSTITIAL IMPLANT ACCESSORIES2Cleared 510(K)
- K041715INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.0012Cleared 510(K)
- K042360VARIAN NASOPHARYNX APPLICATOR2Cleared 510(K)
- K042586BEST BREAST BRACHYTHERAPY APPLICATOR2Cleared 510(K)
- K041929MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY2Cleared 510(K)
- K041933MICROSELECTRON PDR2Cleared 510(K)
- K040704MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR2Cleared 510(K)
- K040541MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER2Cleared 510(K)
- K032067MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY2Cleared 510(K)
- K033828CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 94062Cleared 510(K)
- K033371VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS2Cleared 510(K)
- K031524GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER2Cleared 510(K)
- K032372NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.0072Cleared 510(K)
- K031158SWIFT 2.0, MODEL 132.0012Cleared 510(K)
- K031273AMERITEK SURE-POINT HDR NEEDLE TEMPLATE2Cleared 510(K)
- K030558MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY2Cleared 510(K)
- K030110CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR2Cleared 510(K)
- K023220VARISOURCE BREAST TEMPLATE SYSTEM2Cleared 510(K)
- K022739REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.0022Cleared 510(K)
- K022635KUSKE BREAST APPLICATOR SET, MODEL 189.0062Cleared 510(K)
- K021286MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES2Cleared 510(K)
- K011690MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY2Cleared 510(K)
- K020176HDR MIAMI APPLICATOR2Cleared 510(K)
- K020015IMPLANT GUIDANCE SYSTEM APPLICATOR SET2Cleared 510(K)
- K010032SEED SELECTRON MODEL V. 1.02Cleared 510(K)
- K011657HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR2Cleared 510(K)
- K003270PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,0672Cleared 510(K)
- K000081MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM2Cleared 510(K)
- K001544VAGINAL APPLICATOR SHIELDED2Cleared 510(K)
- K001825STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER2Cleared 510(K)
- K993472SEGMENTED VAGINAL APPLICATOR2Cleared 510(K)
- K993400HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES2Cleared 510(K)
- K990990CET PROSTATE APPLICATOR SET, PART NUMBER 089.0662Cleared 510(K)
- K990753GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER2Cleared 510(K)
- K983338FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.0952Cleared 510(K)
- K983341STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL CT/MR APPLICATOR SET, FLETCHER WILLIAMSON APPLICATOR SE2Cleared 510(K)
- K983337ROTTERDAM NASOPHAYRNX MOULD SET, PART #089.0682Cleared 510(K)
- K983115TREATMENT CONTROL STATION - MICROSELECTRON-HDR CLASSIC UPGRADE, VERSION 1.202Cleared 510(K)
- K981886VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER2Cleared 510(K)
- K980576VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER2Cleared 510(K)
- K983436GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM2Cleared 510(K)
- K980590VARISOURCE HENSCHKE TYPE GYN APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER2Cleared 510(K)
- K980601VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER2Cleared 510(K)
- K964910AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS2Cleared 510(K)
- K961601H.A.M. APPLICATOR2Cleared 510(K)
- K953946MICROSELECTRON-HDR VERSION 22Cleared 510(K)
- K955844APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER2Cleared 510(K)
- K954467CADPLAN BT2Cleared 510(K)
- K952913APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH SOES RATE AFTERLOADER2Cleared 510(K)
- K945383HIGH DOSE RATE AFTERLOADER2Cleared 510(K)
- K943109REMOTE CONTROL RADIOISOTOPE APPLICATOR2Cleared 510(K)
- K925956MICROSELECTRON - HDR FOR MOBILE ENVIRONMENT2Cleared 510(K)
- K923738HIGH DOSE RATE REMOTE AFTERLOADING CATHETER2Cleared 510(K)
- K9225646 FRENCH CATHETER2Cleared 510(K)
- K901615PULMOCATH INTRABRONCHIAL CATHETER2Cleared 510(K)
- K915622PLATO BRACHYTHERAPHY TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K922554STANDARD IMAGING HDR 1000 ION CHAMBER2Cleared 510(K)
- K920431OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE2Cleared 510(K)
- K915367HDRS-1 SYSTEM2Cleared 510(K)
- K913908OMNITRON GYN APPLICATOR SYSTEM2Cleared 510(K)
- K914578RTS TECHNOLOGY MODELS 721,722,723,7242Cleared 510(K)
- K912555GAMMAMED 12IT HIGH DOSE RATE REMOTE AFTERLOADER2Cleared 510(K)
- K902533PULSED SELECTRON2Cleared 510(K)
- K901589RTS TECHNOLOGY IRIDIUM 192 SOURCES2Cleared 510(K)
- K890294INTER-PAL C-19 AND INTER-PAL C-382Cleared 510(K)
- K894381GAMMAMED IRIDIUM-192 SOURCE2Cleared 510(K)
- K890799CURIETRON 192 HIGH DOSE RATE2Cleared 510(K)
- K891131GAMMAMED 12I2Cleared 510(K)
- K881323CURIETRON 192 LOW DOSE RATE2Cleared 510(K)
- K881665OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR2Cleared 510(K)
- K864210MICROSELECTRON-HDR (HIGH DOSE RATE)2Cleared 510(K)
- K853912MICROSELECTION INTERSTITIAL REMOTE AFTERLOAD SYS2Cleared 510(K)
- K852842SELECTRON HDR REMOTE AFTERLOADER2Cleared 510(K)
- K844714SELECTRON LDR SELECTRON LOW DOSE RATE2Cleared 510(K)
- K840127CURIETRON2Cleared 510(K)
- K834308MULTITREAT 482Cleared 510(K)
- K832789AFTER LOADING BUCHLER2Cleared 510(K)
- K810051SELECTRON REMOTE ISOTOPE2Cleared 510(K)
- K781274GAMMA MED II2Cleared 510(K)
- KPQSystem, Simulation, Radiation Therapy2Product Code
- KPZGenerator, High Voltage, X-Ray, Therapeutic2Product Code
- KQADevice, Beam Limiting, X-Ray, Therapeutic2Product Code
- KXKSource, Brachytherapy, Radionuclide2Product Code
- 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
“BRAXX” Esophageal Brachytherapy Applicator
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K183332
- 510(k) Type
- Traditional
- Applicant
- Braxx Biotech Co., Ltd.
- Country
- Taiwan
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/16/2019
- Days to Decision
- 134 days
- Submission Type
- Summary