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
- EAGCephalometer2Product Code
- EAHCone, Radiographic, Lead-Lined1Product Code
- EAPUnit, X-Ray, Intraoral2Product Code
- EHBCollimator, X-Ray1Product Code
- EHDUnit, X-Ray, Extraoral With Timer2Product Code
- K242185Rextar Pro2Cleared 510(K)
- K242591XERO-alpha2Cleared 510(K)
- K241963WERAY2Cleared 510(K)
- K241305LifeRay Intraoral Handheld X-ray System2Cleared 510(K)
- K240759REMEX-GR1002Cleared 510(K)
- K233914XVbeam20002Cleared 510(K)
- K233395Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)2Cleared 510(K)
- K231055x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)2Cleared 510(K)
- K232085DVAS (DVAS-M, DVAS-W)2Cleared 510(K)
- K232012N12Cleared 510(K)
- K232068HyperLight Portable X-ray Unit2Cleared 510(K)
- K231449Portable X-ray System Model Ray98(P)2Cleared 510(K)
- K223780Lumos 3DX2Cleared 510(K)
- K221587DHX-70H, XTG-70H2Cleared 510(K)
- K223010Portable X-ray System2Cleared 510(K)
- K222569Ai Ray Dental X-Ray Device2Cleared 510(K)
- K223058EzRay Air 2 Wall (Model: VEX-S350W)2Cleared 510(K)
- K220579Hybrid C702Cleared 510(K)
- K222274FONA XDC2Cleared 510(K)
- K221286CLAROX2Cleared 510(K)
- K221233DT-7032Cleared 510(K)
- K220574HYBRID S702Cleared 510(K)
- K213282ERI Handheld Dental X-ray System (Model AG100)2Cleared 510(K)
- K211014Portray2Cleared 510(K)
- K201800Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)2Cleared 510(K)
- K200182EzRay Air Portable (Model: VEX-P300)2Cleared 510(K)
- K192700Xcam2Cleared 510(K)
- K190935EZER, Portable X-ray System2Cleared 510(K)
- K180671MINE2Cleared 510(K)
- K190357Star-X, Intraoral X-ray System2Cleared 510(K)
- K182206RiX70 DC2Cleared 510(K)
- K181891Portable X-ray System (Model: MiniX-V, Mini X-S)2Cleared 510(K)
- K180561MobileX Portable X-ray System2Cleared 510(K)
- K172928Portable X-ray System2Cleared 510(K)
- K172810PORT-X IV2Cleared 510(K)
- K173319KaVo NOMAD Pro 2 Handheld X-ray System2Cleared 510(K)
- K170967Intraskan DC Plus2Cleared 510(K)
- K163705EzRay Air W2Cleared 510(K)
- K163519RX DC2Cleared 510(K)
- K161063EzRay Air (Model VEX-P300)2Cleared 510(K)
- K160458BI IMAGE-X EVOLUTION2Cleared 510(K)
- K152859Portable X-ray System (Model: MINIX-V / MINIX-S)2Cleared 510(K)
- K141293PHOT-X IIS MODEL 5052Cleared 510(K)
- K141497PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO)2Cleared 510(K)
- K132378X-MIND UNITY2Cleared 510(K)
- K130109ENDOGRAPH DC2Cleared 510(K)
- K132041REXTAR X2Cleared 510(K)
- K122124PORTABLE X-RAY SYSTEM2Cleared 510(K)
- K122016REXTAR, REXTAR LCD2Cleared 510(K)
- K123493VEX-S 100W INTRAORAL X-RAY SYSTEM2Cleared 510(K)
- K122582DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C)2Cleared 510(K)
- K111330AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY2Cleared 510(K)
- K103600PORTABLE X-RAY SYSTEM2Cleared 510(K)
- K103579INTRA SKAN DC2Cleared 510(K)
- K093105VISTEO2Cleared 510(K)
- K091255MINXRAY, MODEL: BPD602Cleared 510(K)
- K093240BELRAY II2Cleared 510(K)
- K092772PORTABLE X-RAY SYSTEM, MODEL HAND-RAY2Cleared 510(K)
- K092103DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX)2Cleared 510(K)
- K091197PLANMECA PROSENSOR2Cleared 510(K)
- K090749ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY11912Cleared 510(K)
- K082875PORTABLE X-RAY SYSTEM, MODEL DXR -12Cleared 510(K)
- K083344HELIODENT PLUS2Cleared 510(K)
- K082167PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX2Cleared 510(K)
- K081899ANYRAY PORTABLE X-RAY SYSTEM2Cleared 510(K)
- K081664NOMAD PRO X-RAY SYSTEM2Cleared 510(K)
- K080076RX DC X-RAY UNIT2Cleared 510(K)
- K063121PORTABLE X-RAY SYSTEM, MODEL PORT-X II2Cleared 510(K)
- K060640DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM2Cleared 510(K)
- K060292KODAK MODELS 2100 AND 22002Cleared 510(K)
- K051795NOMAD DENTAL X-RAY SYSTEM2Cleared 510(K)
- K051464PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)2Cleared 510(K)
- K050255ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G42Cleared 510(K)
- K043104KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.02Cleared 510(K)
- K043612ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D2Cleared 510(K)
- K050019IN EXAM INTRAORAL DENTAL X-RAY SYSTEM2Cleared 510(K)
- K043557MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS2Cleared 510(K)
- K043136ELITY 70 X-RAY2Cleared 510(K)
- K043307CRANEX D2Cleared 510(K)
- K043092PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P70152Cleared 510(K)
- K042260PHOT-X II, MODEL 3032Cleared 510(K)
- K040382CRANEX BASEX D OR CRANEX EXCEL D2Cleared 510(K)
- K040748ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM2Cleared 510(K)
- K033755MINRAY2Cleared 510(K)
- K040556TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY2Cleared 510(K)
- K033690TROPHYPAN AND TROPHYPAN C2Cleared 510(K)
- K033073ORTHOPHOS XG DS/CEPH2Cleared 510(K)
- K032355ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW2Cleared 510(K)
- K031448RSV (RADIOLOGY SYSTEM VISIODENT2Cleared 510(K)
- K031802CORIX 70 PLUS-USV2Cleared 510(K)
- K030634ENDOS DC2Cleared 510(K)
- K031118INTRAOS 702Cleared 510(K)
- K024285A/T X-RAY 702Cleared 510(K)
- K030647EVA DIGITAL DENTAL X-RAY SYSTEM2Cleared 510(K)
- K030185ENDOS AC/ACP2Cleared 510(K)
- K022630MODIFICATION TO FOCUS2Cleared 510(K)
- K021378PORTABLE HDX INTRAORAL X-RAY2Cleared 510(K)
- K021245DEGOTZEN SYNCHRO2Cleared 510(K)
- K011147CAVITAT ULTRASOUND BONE DENSITOMETER (CAVITAT)2Cleared 510(K)
- K013955VERAVIEWEPOCS, MODEL VE2Cleared 510(K)
- K020070JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A00022Cleared 510(K)
- K013176MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE2Cleared 510(K)
- K012355IMAGE-X SYSTEM2Cleared 510(K)
- K011619PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT2Cleared 510(K)
- K002062SAMSUNG 10DR IMPLANT SYSTEM2Cleared 510(K)
- K002432STRATO X2Cleared 510(K)
- K001729FOCUS2Cleared 510(K)
- K001248MULTI-PULSE 20002Cleared 510(K)
- K000771DIMAX 22Cleared 510(K)
- K000672HELIODENT VARIO2Cleared 510(K)
- K000428DIXI 22Cleared 510(K)
- K000163PM 2002 PROLINE/AEC2Cleared 510(K)
- K000061MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT2Cleared 510(K)
- K000551IMAGE X-70 PLUS DENTAL X-RAY UNIT2Cleared 510(K)
- K994285ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORTHORALIX 9200 PLUS CEPH2Cleared 510(K)
- K992610GENDEX 765DC, MODEL 110-01542Cleared 510(K)
- K991455ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C,2Cleared 510(K)
- K991912MODIFICATION TO DIGIPAN2Cleared 510(K)
- K991518PANATOME2Cleared 510(K)
- K991310EXPLOR-X 702Cleared 510(K)
- K984030VIPERSOFT2Cleared 510(K)
- K984524AZTECH 702Cleared 510(K)
- K980581PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM2Cleared 510(K)
- K980543DENOPTIX BARRIER ENVELOPE (SIZE 0-4)2Cleared 510(K)
- K974877CRANEX TOME CEPH, OR CRANEX TOME2Cleared 510(K)
- K974077VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS.2Cleared 510(K)
- K972921SANKO INTRAORAL DENTAL X-RAY2Cleared 510(K)
- K973642ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC1002Cleared 510(K)
- K973476KODAK DIGITAL SCIENCE-DENTAL IMAGE VIEWER2Cleared 510(K)
- K972968ROTOGRAPH PLUS2Cleared 510(K)
- K972312SIEMENS ORTHOPHOS DS/DS CEPH2Cleared 510(K)
- K972249ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD2Cleared 510(K)
- K962422INFIMED DENTAL SYSTEM2Cleared 510(K)
- K972168SIDEXIS DIGITAL RADIOGRAPHY SYSTEM2Cleared 510(K)
- K970812PM 2002 CC PROLINE2Cleared 510(K)
- K970850SCANRITE DFS2Cleared 510(K)
- K970975PROSTYLE INTRA2Cleared 510(K)
- K965203RADX SYSTEM2Cleared 510(K)
- K970263PM 2002 CC PROLINE2Cleared 510(K)
- K965072PANOURA ULTRA PAN AND PANOURA ULTRA PAN/CEPH PANORAMIC/CEPHALOMETRIC X-RAY UNIT2Cleared 510(K)
- K963403ACURAY DIGITAL X-RAY2Cleared 510(K)
- K964659ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM2Cleared 510(K)
- K963699BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY2Cleared 510(K)
- K962631DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM2Cleared 510(K)
- K963185ELECTRONIC X-RAY TIMER 1400A, 1400AW AND UNIVERSAL DIGITAL DENTAL X-RAY TIMER2Cleared 510(K)
- K961826DIGIPAN2Cleared 510(K)
- K962337ELITYS OR ELITYS-E2Cleared 510(K)
- K962120TOMOGRAPH ACCESSORIES2Cleared 510(K)
- K955429PROSTYLE INTRA2Cleared 510(K)
- K952763PANORAMIC X-RAY UNIT (MODIFICATION)2Cleared 510(K)
- K931300FLASH DENT2Cleared 510(K)
- K935046GX-770 X-RAY CONTROL, MODEL 46-404600G42Cleared 510(K)
- K932111DENTAL X-RAY UNIT2Cleared 510(K)
- K934063PANORAMIC X-RAY UNITS, MODIFICATION2Cleared 510(K)
- K925094VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS2Cleared 510(K)
- K931001ORALIX DC2Cleared 510(K)
- K931725ALPHA II2Cleared 510(K)
- K930338ORTHOCEPH OC1002Cleared 510(K)
- K926575MAMMOTEST PRODUCT, MODIFICATION2Cleared 510(K)
- K923360PORT-XD2Cleared 510(K)
- K924130COFFMAN IMPLANT TOMOGRAPH2Cleared 510(K)
- K923067SENS-A-RAY2Cleared 510(K)
- K912893ORTHOPANTOMOGRAPH 1002Cleared 510(K)
- K913652COFFMAN TOMOGRAPH2Cleared 510(K)
- K894935S-70 PORTABLE DENTAL X-RAY SYSTEM2Cleared 510(K)
- K895467ORTHOPHOS AND ORTHOPHOS C2Cleared 510(K)
- K882436LASER - 10002Cleared 510(K)
- K875212PXS MODEL PXS7-730EA DENTAL X-RAY SOURCE2Cleared 510(K)
- K872825AXIAL TOME, 60, FLUORO AND TOMAX2Cleared 510(K)
- K874238MODEL 2001 CP, PHOTON I, DENTAL, INTRAORAL X-RAY2Cleared 510(K)
- K872240PORTABLE DENTAL X-RAY UNIT MODEL 40002Cleared 510(K)
- K871051FIAD EXPLOR-X; MODEL 70 KVP2Cleared 510(K)
- K870236PANORAMIC X-RAY MODEL PC-10002Cleared 510(K)
- K864474DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC2Cleared 510(K)
- K860835CEPHALOSTAT2Cleared 510(K)
- K854741X-RANGE 652Cleared 510(K)
- K851095INTRAORAL DENTAL X-RAY SYSTEM 70-X2Cleared 510(K)
- K811103GE 9002Cleared 510(K)
- K800133PANOREX II DENTAL X-RAY UNIT2Cleared 510(K)
- K792581GENERAL ELECTRIC PANELIPSE LD2Cleared 510(K)
- K781288DENTAL X-RAY UNIT HELIODENT 702Cleared 510(K)
- K781286DENTAL X-RAY UNIT2Cleared 510(K)
- K780469PANORAMIC X-RAY, DENTAL2Cleared 510(K)
- K772164PANORAMIC X-RAY SYSTEM MODEL A2Cleared 510(K)
- MUHSystem, X-Ray, Extraoral Source, Digital2Product Code
- EAMScreen, Intensifying, Radiographic1Product Code
- EGTController, Temperature, Radiographic2Product Code
- EGWDryer, Film, Radiographic2Product Code
- EGYProcessor, Radiographic-Film, Automatic, Dental2Product Code
- HBKChair, Pneumoencephalographic2Product Code
- ITXTransducer, Ultrasonic, Diagnostic2Product Code
- ITYAssembly, Tube Housing, X-Ray, Diagnostic1Product Code
- IWNCassette, Measurement, Ardran-Crooks1Product Code
- IWYHolder, Head, Radiographic1Product Code
- IWZFilm, Radiographic1Product Code
- IXACassette, Radiographic Film2Product Code
- IXCIlluminator, Radiographic-Film1Product Code
- IXDSource, Calibration, Sealed, Nuclear1Product Code
- IXFTest-Pattern, Radiographic1Product Code
- IXGPhantom, Anthropomorphic, Radiographic1Product Code
- IXHCamera, Focal Spot, Radiographic1Product Code
- IXJGrid, Radiographic1Product Code
- IXKSystem, Imaging, X-Ray, Electrostatic2Product Code
- IXLDevice, Spot-Film2Product Code
- IXOSynchronizer, Ecg / Respirator, Radiographic1Product Code
- IXQTable, Radiographic, Stationary Top2Product Code
- IXRTable, Radiographic, Tilting2Product Code
- IXWProcessor, Radiographic-Film, Automatic2Product Code
- IXXProcessor, Cine Film2Product Code
- IXYHolder, Radiographic Cassette, Wall-Mounted1Product Code
- IYBTube Mount, X-Ray, Diagnostic1Product Code
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic2Product Code
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic2Product Code
- IYPPhantom, Anthropomorphic, Nuclear1Product Code
- IYQPhantom, Flood Source, Nuclear1Product Code
- IYTSystem, Rebreathing, Radionuclide2Product Code
- IYWScanner, Rectilinear, Nuclear1Product Code
- IYXCamera, Scintillation (Gamma)1Product Code
- IYYSynchronizer, Electrocardiograph, Nuclear1Product Code
- IYZBed, Scanning, Nuclear1Product Code
- IZCCamera, Positron1Product Code
- IZDProbe, Uptake, Nuclear1Product Code
- IZFSystem, X-Ray, Tomographic2Product Code
- IZGSystem, X-Ray, Photofluorographic2Product Code
- IZHSystem, X-Ray, Mammographic2Product Code
- IZISystem, X-Ray, Angiographic2Product Code
- IZJCamera, X-Ray, Fluorographic, Cine Or Spot2Product Code
- IZLSystem, X-Ray, Mobile2Product Code
- IZOGenerator, High-Voltage, X-Ray, Diagnostic1Product Code
- IZPProgrammer, Changer, Film/Cassette, Radiographic2Product Code
- IZSAperture, Radiographic2Product Code
- IZTCone, Radiographic2Product Code
- IZWCollimator, Automatic, Radiographic2Product Code
- IZXCollimator, Manual, Radiographic2Product Code
- IZZTable, Radiographic, Non-Tilting, Powered2Product Code
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified2Product Code
- JABSystem, X-Ray, Fluoroscopic, Non-Image-Intensified2Product Code
- JACSystem, X-Ray, Film Marking, Radiographic1Product Code
- JAFMonitor, Ultrasonic, Nonfetal2Product Code
- JAGIlluminator, Radiographic-Film, Explosion-Proof1Product Code
- JAKSystem, X-Ray, Tomography, Computed2Product Code
- JAMScanner, Whole Body, Nuclear1Product Code
- JANCounter, Whole Body, Nuclear1Product Code
- JAOScanner, Fluorescent2Product Code
- JARPhantom, Test-Pattern, Radionuclide1Product Code
- JWMSystem, Tomographic, Nuclear2Product Code
- KGIDensitometer, Bone2Product Code
- KPRSystem, X-Ray, Stationary2Product Code
- KPSSystem, Tomography, Computed, Emission2Product Code
- KPTCalibrator, Dose, Radionuclide2Product Code
- KPWDevice, Beam Limiting, X-Ray, Diagnostic2Product Code
- KPXChanger, Radiographic Film/Cassette2Product Code
- KXHCradle, Patient, Radiologic1Product Code
- KXJTable, Radiologic2Product Code
- LEKTransilluminator (Diaphanoscope)3Product Code
- LHOInstrument, Quality-Assurance, Radiologic1Product Code
- LLZSystem, Image Processing, Radiological2Product Code
- LMADigitizer, Image, Radiological2Product Code
- LMBDevice, Digital Image Storage, Radiological1Product Code
- LMCCamera, Multi Format, Radiological2Product Code
- LMDSystem, Digital Image Communications, Radiological1Product Code
- LNHSystem, Nuclear Magnetic Resonance Imaging2Product Code
- LNISystem, Nuclear Magnetic Resonance Spectroscopic2Product Code
- LQAMedia, Reusable Image1Product Code
- MOSCoil, Magnetic Resonance, Specialty2Product Code
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)2Product Code
- MUABone Sonometer2Product Code
- MUEFull Field Digital, System, X-Ray, Mammographic2Product Code
- MUIMedia, Coupling, Ultrasound2Product Code
- MWPCabinet, X-Ray System2Product Code
- MYNAnalyzer, Medical Image2Product Code
- NCSSystem, Imaging, Holography, Acoustic2Product Code
- NWEColon Computed Tomography System, Computer Aided Detection2Product Code
- OASX-Ray, Tomography, Computed, Dental2Product Code
- OEBLung Computed Tomography System, Computer-Aided Detection2Product Code
- OIIArthrogram Tray2Product Code
- OIJBiopsy Needle Guide Kit2Product Code
- OIKRadiology Dental Tray2Product Code
- OILDiscography Kit2Product Code
- OIMMri Disposable Kit2Product Code
- OIORadiographic Contrast Tray2Product Code
- OIPRadiology-Diagnostic Kit2Product Code
- OMJChest X-Ray Computer Aided Detection2Product Code
- OQQDiagnostic Ultrasonic Transducer, Robotic2Product Code
- OUOTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance2Product Code
- OWBInterventional Fluoroscopic X-Ray System2Product Code
- OXOImage-Intensified Fluoroscopic X-Ray System, Mobile2Product Code
- PGYDisplay, Diagnostic Radiology2Product Code
- POKComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer2Product Code
- QASRadiological Computer-Assisted Triage And Notification Software2Product Code
- QFMRadiological Computer-Assisted Prioritization Software For Lesions2Product Code
- QHAX-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device2Product Code
- QHXFluoroscopic X-Ray Image Intensifier1Product Code
- QHYSolid State Fluoroscopic X-Ray Imager2Product Code
- QIHAutomated Radiological Image Processing Software2Product Code
- QKBRadiological Image Processing Software For Radiation Therapy2Product Code
- RCCC-Arm Fluoroscopic X-Ray System2Product Code
- QTZRadiological Image Processing Software For Ablation Therapy Planning And Evaluation2Product Code
- QXLCabinet, Emission Computed Tomography System2Product Code
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K043092
- 510(k) Type
- Traditional
- Applicant
- PROGENY, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/13/2004
- Days to Decision
- 34 days
- Submission Type
- Summary