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
- 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
- K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)2Cleared 510(K)
- K241505DRX-Revolution Mobile X-ray System2Cleared 510(K)
- K240841Digital Radiography System (ManntiX B, ManntiX K)2Cleared 510(K)
- K242515uDR 380i Pro2Cleared 510(K)
- K242651GM852Cleared 510(K)
- K234108ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)2Cleared 510(K)
- K240009iQFlex Pro2Cleared 510(K)
- K240284Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)2Cleared 510(K)
- K233678Radiography 7000 M2Cleared 510(K)
- K232185SM-IV2Cleared 510(K)
- K230581TOPA12 Portable X-ray Unit2Cleared 510(K)
- K231577MOBILETT Impact2Cleared 510(K)
- K222896AirRay2Cleared 510(K)
- K222951SM-V2Cleared 510(K)
- K222258Combined High Frequency X-ray Source2Cleared 510(K)
- K222339uDR 380i Pro2Cleared 510(K)
- K222353GM852Cleared 510(K)
- K221417CLAROX plus (Model: VX-100)2Cleared 510(K)
- K221803PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.2Cleared 510(K)
- K213405MINE ALNU (Model: Mine 2.1)2Cleared 510(K)
- K221081iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System2Cleared 510(K)
- K220700Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine2Cleared 510(K)
- K220175GM852Cleared 510(K)
- K220678APX-24 Portable X-ray System2Cleared 510(K)
- K213568DRX-Rise Mobile X-ray System2Cleared 510(K)
- K212940Skanmobile, Skanmobile-Dr2Cleared 510(K)
- K213462EzRay M18 (Model: VMX-P400)2Cleared 510(K)
- K212654Micro C Medical Imaging System, M012Cleared 510(K)
- K212515MOVIX DReamy2Cleared 510(K)
- K212291PHOENIX2Cleared 510(K)
- K212134Diagnostic X-ray System/PLX5200A2Cleared 510(K)
- K211383NFLK-2501 Portable X-ray Unit2Cleared 510(K)
- K212144Remex KA62Cleared 510(K)
- K211473Micro C Medical Imaging System, M012Cleared 510(K)
- K211423Rover2Cleared 510(K)
- K210982AMX Navigate2Cleared 510(K)
- K203782Nanox Cart X-ray System2Cleared 510(K)
- K210479IMPACT and X-Ranger2Cleared 510(K)
- K203667EzRay M (Model: VMX-P300)2Cleared 510(K)
- K203658Micro C Medical Imaging System, M012Cleared 510(K)
- K202350SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System2Cleared 510(K)
- K202353SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System2Cleared 510(K)
- K201488Rover2Cleared 510(K)
- K200637SR-8100 Portable X-ray Unit2Cleared 510(K)
- K201575CMDR 2C (Multiple Models)2Cleared 510(K)
- K201340AQUILA 320 D / AQUILA 320 S2Cleared 510(K)
- K200976SR-8230, SR-8230S Portable X-ray Unit2Cleared 510(K)
- K201124TOPAZ Mobile DR System2Cleared 510(K)
- K193535EZER, Portable X-ray System2Cleared 510(K)
- K200726AcuityPDR2Cleared 510(K)
- K192936Soltus 5002Cleared 510(K)
- K192011PhoeniX2Cleared 510(K)
- K191884DR 100s2Cleared 510(K)
- K191813MobileDiagnost wDR 2.22Cleared 510(K)
- K191451CMDR 2CW (Multiple models)2Cleared 510(K)
- K191025DRX-Revolution Mobile X-ray System2Cleared 510(K)
- K183292Topaz Mobile DR System2Cleared 510(K)
- K182639MOBILETT Elara Max2Cleared 510(K)
- K183388JADE Mobile X-Ray2Cleared 510(K)
- K182207TR90BH2Cleared 510(K)
- K182317AMADEO M-DR mini, AMADEO M-AX mini2Cleared 510(K)
- K181874MX40 Mobile Digital X-ray System2Cleared 510(K)
- K182234Optima XR240amx2Cleared 510(K)
- K181626Digital Diagnostic Mobile X-ray System2Cleared 510(K)
- K173924DRX-Revolution Nano Mobile X-ray System2Cleared 510(K)
- K173299DRAGON X SPSL4HC, DRAGON X SPSL8HC2Cleared 510(K)
- K173602Optima XR240amx, AutoGrid2Cleared 510(K)
- K173018MDR17 Mobile Direct Radiographic System2Cleared 510(K)
- K173187MobileDiagnost M502Cleared 510(K)
- K170607!M12Cleared 510(K)
- K170755DRX-Revolution Nano Mobile X-ray System2Cleared 510(K)
- K171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris2Cleared 510(K)
- K171119GM852Cleared 510(K)
- K170858FDR AQRO (DR-XD 1000)2Cleared 510(K)
- K163063UC-5000 Mobile X-Ray2Cleared 510(K)
- K162990Optima XR240amx2Cleared 510(K)
- K162278Digital Diagnostic Mobile X-ray System2Cleared 510(K)
- K162687Paragon 22Cleared 510(K)
- K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR2Cleared 510(K)
- K153059HF1202H PowerPlus Portable X-ray Equipment2Cleared 510(K)
- K143494ADX6000 Portable X-Ray System; iRayA62Cleared 510(K)
- K151038EPX-Series Mobile X-ray System2Cleared 510(K)
- K143537Sirius Starmobile tiara2Cleared 510(K)
- K150097GM60A-32S & GM60A-40S2Cleared 510(K)
- K142492GM60A-32S, GM60A-40S2Cleared 510(K)
- K141539KUBTEC X2502Cleared 510(K)
- K142383Optima XR200amx, Optima XR220amx2Cleared 510(K)
- K141895MOBILEDIAGNOST WDR2Cleared 510(K)
- K141885CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY2Cleared 510(K)
- K140723NOMAD MD 75K V HANDHELD X-RAY SYSTEM2Cleared 510(K)
- K122298AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR2Cleared 510(K)
- K122697PORTA 100HF2Cleared 510(K)
- K121410DRAGON LW2Cleared 510(K)
- K120062DRX-REVOLUTION MOBILE X-RAY SYSTEM2Cleared 510(K)
- K111912MOBILETT MIRA2Cleared 510(K)
- K101517SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY2Cleared 510(K)
- K111725MOBILEDIAGNOST WDR2Cleared 510(K)
- K103476BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX2Cleared 510(K)
- K103522SEDECAL2Cleared 510(K)
- K103597DX-D 1002Cleared 510(K)
- K092713SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM2Cleared 510(K)
- K100449MINXRAY MODEL CMDR-2S2Cleared 510(K)
- K100400PRESTODR PORTABLE2Cleared 510(K)
- K090655PORTABLE X-RAY SYSTEM, MODEL POWERMAX 12602Cleared 510(K)
- K090268SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION2Cleared 510(K)
- K090322EASY MOVING PLUS, SM-XXHF-YY2Cleared 510(K)
- K083048NEORAY DR 2520 DIGITAL IMAGING SYSTEM2Cleared 510(K)
- K082627MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL2Cleared 510(K)
- K080701SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION2Cleared 510(K)
- K080945FCR GO PORTABLE DIGITAL X-RAY SYSTEM2Cleared 510(K)
- K072392OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM2Cleared 510(K)
- K070634SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-1102Cleared 510(K)
- K071015OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM2Cleared 510(K)
- K063262AMX4-50 AND AMX4-31 MOBILE DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS2Cleared 510(K)
- K062472OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-1152Cleared 510(K)
- K061685PULSERA2Cleared 510(K)
- K060566MINXRAY, MODELS HFP24 AND HFP402Cleared 510(K)
- K052897GE DEFINIUM AMX 700, MODEL AMX 7002Cleared 510(K)
- K052721MINXRAY, MODEL HF100H+2Cleared 510(K)
- K052341AJEX 9015/135H PORTABLE X-RAY2Cleared 510(K)
- K052001MODEL SR-115 PORTABLE X-RAY SYSTEM2Cleared 510(K)
- K043062MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM2Cleared 510(K)
- K043002SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR2Cleared 510(K)
- K042866AMX5 AND AMX5D MOBILE X-RAY SYSTEMS2Cleared 510(K)
- K042368PRACTIX CONVENIO2Cleared 510(K)
- K042361DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D2Cleared 510(K)
- K041922GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR2Cleared 510(K)
- K041763SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES2Cleared 510(K)
- K040046MINXRAY, MODEL HF120/60H POWERPLUS2Cleared 510(K)
- K032628PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF2Cleared 510(K)
- K033238MOBILETTE XP AND MOBILETT XPHYBRID2Cleared 510(K)
- K032280SIREMOBIL ISO-C 3D2Cleared 510(K)
- K030494SR-1302Cleared 510(K)
- K0223373D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D2Cleared 510(K)
- K021016AMX-4 PLUS MOBILE X-RAY SYSTEM2Cleared 510(K)
- K020436PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.02Cleared 510(K)
- K012663EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF)2Cleared 510(K)
- K012379PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM2Cleared 510(K)
- K010304MXR-2000 MOBILE X-RAY UNIT2Cleared 510(K)
- K002685CORDLESS COMPACT MOBILE X-RAY SYSTEM2Cleared 510(K)
- K001517SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES2Cleared 510(K)
- K992229MXU-125 OR TMX-1252Cleared 510(K)
- K981466XR-9102Cleared 510(K)
- K973833CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL2Cleared 510(K)
- K973712MINXRAY HF100H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT2Cleared 510(K)
- K972365COMPACT OR COMP-X2Cleared 510(K)
- K972204ACU-RAY HF SERIES PORTABLE X-RAY UNIT2Cleared 510(K)
- K970234SEALED LEAD ACID BATTERY PACK2Cleared 510(K)
- K955036MOBILE X-RAY SYSTEM2Cleared 510(K)
- K955095SIERRA BATTERY SEALED LEAD ACID BATTERY SYSTEM2Cleared 510(K)
- K953404OSTEO-RAY 1002Cleared 510(K)
- K953292CP 100/302Cleared 510(K)
- K944442GENERAL ELECTRIC AMX 110, AMX II AND AMX 32Cleared 510(K)
- K945043BATTERY PACK #PMX120-18A2Cleared 510(K)
- K945707MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT2Cleared 510(K)
- K932106MOBILETT PLUS MOBILE X-RAY SYSTEM2Cleared 510(K)
- K941363PHANTOM2Cleared 510(K)
- K931483REPLACEMENT BATERY FOR GE AMX-4 PORT. X-RAY MACH.2Cleared 510(K)
- K932353HF-110A2Cleared 510(K)
- K934818HAND HELD DENTAL X-RAY DEVICE2Cleared 510(K)
- K931279ACU-RAY2Cleared 510(K)
- K930699M6-M2Cleared 510(K)
- K9323559150A, 1100F2Cleared 510(K)
- K9323549170, 11702Cleared 510(K)
- K931200BATTERY PACKS (VARIOUS MODELS)2Cleared 510(K)
- K930049INFRARED EXPOSURE HAND SWITCH2Cleared 510(K)
- K923359PORT-XP2Cleared 510(K)
- K924798BATTERY PACK2Cleared 510(K)
- K921116PX-100 PORTABLE X-RAY GENERATOR2Cleared 510(K)
- K921425SCD-105 AND SCD-125 CAPACITOR DISCHARGE MOBILE X-R2Cleared 510(K)
- K910902VMX MOBILE X-RAY SYSTEM2Cleared 510(K)
- K912323THE REMOTE2Cleared 510(K)
- K911841MINXRAY P300 X-RAY SYSTEM2Cleared 510(K)
- K912400MOBILE X-RAY FLOOR STAND2Cleared 510(K)
- K902984G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS2Cleared 510(K)
- K902610GENERAL ELECTRIC AMX 32Cleared 510(K)
- K894643RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT2Cleared 510(K)
- K894021MOBILE X-RAY UNIT2Cleared 510(K)
- K893637MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM2Cleared 510(K)
- K891143GENERAL ELECTRIC AMX 1102Cleared 510(K)
- K891142GENERAL ELECTRIC AMX II2Cleared 510(K)
- K890306BCM-ARC 105 X-RAY MOBILE UNIT2Cleared 510(K)
- K883092BENNETT BCA-6 &BCA-9 MOBILE C-ARM UNIT/RADIO/FLOUR2Cleared 510(K)
- K875106PB-A LEAD-ACID BATTERY CONVERSION KIT2Cleared 510(K)
- K874840BENNETT PORTABLE RADIOGRAPHIC SYSTEM NO. SPR-100A2Cleared 510(K)
- K873982GX-MOBILE X-RAY UNIT2Cleared 510(K)
- K862452MX MOBILE X-RAY SYSTEM2Cleared 510(K)
- K862118MODEL MBA-130 MOBILE X-RAY SYSTEM2Cleared 510(K)
- K850678AIM N' SHOOT - AUTOMATIC EXPOSURE CONTROL2Cleared 510(K)
- K843192APR MOBILE2Cleared 510(K)
- K833239PORTA. X-RAY UNIT FP220 SCM-1-ETC,2Cleared 510(K)
- K833226PMX MOBILE X-RAY SYSTEM2Cleared 510(K)
- K813128MOBIL-AID AUTOMATIC EXPOSURE CONTROL2Cleared 510(K)
- K811082BETA I & BETA II2Cleared 510(K)
- K810276ALPHA I AND ALPHA II2Cleared 510(K)
- K803103TECHNY REX 3000 MOBILE X-RAY UNIT2Cleared 510(K)
- K802047AMX-III2Cleared 510(K)
- K792665PIXIE2Cleared 510(K)
- K790673OMNIMEDICAL AUTOMATIC 10012Cleared 510(K)
- K790451X-RAY UNITS, GX-101, UCIS-510 AND GX-1112Cleared 510(K)
- K790512PORTABLE X-RAY UNIT2Cleared 510(K)
- K790511MOBILE X-RAY UNIT2Cleared 510(K)
- K790443PORTABLE X-RAY UNIT2Cleared 510(K)
- K790393PORTABLE X-RAY UNIT, MATRIX S GX-1012Cleared 510(K)
- K790392510 CARBINETTE X-RAY UNIT2Cleared 510(K)
- K782155GENERAL EQUIPMENT COVER2Cleared 510(K)
- K781976MOBILE X-RAY UNIT2Cleared 510(K)
- K781982INCLINOMETER, VERMONT2Cleared 510(K)
- K781975MOBILE CARRIER2Cleared 510(K)
- K781705MOBIL XR2Cleared 510(K)
- K781676X-RAY STAND, PORTABLE2Cleared 510(K)
- K781590PORTABLE X-RAY UNIT2Cleared 510(K)
- K781425CAP-MOBILE2Cleared 510(K)
- K781276X-RAY, PORTABLE2Cleared 510(K)
- K781030X-RAY UNIT, PORTABLE GX-101 AEC2Cleared 510(K)
- K780999X-RAY FRAME HOLDER2Cleared 510(K)
- K780947510 BEDSIDE X-RAY SYSTEM2Cleared 510(K)
- K780313HITACHI TECH-MOBLE DHC-1212Cleared 510(K)
- K771571MOBILE X-RAY SYS. MODEL 43820A2Cleared 510(K)
- K770903STERILE CONTINER, X-RAY CASSETTE HOLDER2Cleared 510(K)
- K760741PORTABLE X-RAY2Cleared 510(K)
- 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
TOPAZ Mobile DR System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K201124
- 510(k) Type
- Special
- Applicant
- DRGEM Corporation
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/19/2020
- Days to Decision
- 22 days
- Submission Type
- Summary