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
- K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)2Cleared 510(K)
- K241029SpineUs™ System2Cleared 510(K)
- K233977Velacur2Cleared 510(K)
- K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)2Cleared 510(K)
- K233613ACUSON SC2000 Diagnostic Ultrasound System2Cleared 510(K)
- K232895B-Ultrasound Diagnostic System2Cleared 510(K)
- K232302Pocket III2Cleared 510(K)
- K231677EdgeFlow UH102Cleared 510(K)
- K240146BD Prevue™ II Peripheral Vascular Access System2Cleared 510(K)
- K233401Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)2Cleared 510(K)
- K230986Bladder Scanner2Cleared 510(K)
- K232320iSR`obot Mona Lisa 2.02Cleared 510(K)
- K231889Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)2Cleared 510(K)
- K230511K3900 Ultrasound Imaging System2Cleared 510(K)
- K232459Velacur2Cleared 510(K)
- K231283SiteRite™ 9 Ultrasound System2Cleared 510(K)
- K223448Bladder Scanner Model: BVT022Cleared 510(K)
- K223287Velacur2Cleared 510(K)
- K220068Butterfly iQ/iQ+ Ultrasound System2Cleared 510(K)
- K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)2Cleared 510(K)
- K222787Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P2Cleared 510(K)
- K220933QT Scanner 2000 Model A2Cleared 510(K)
- K213488Bladder Scanner, Model Name:M52Cleared 510(K)
- K211529NAVIRFA Scope2Cleared 510(K)
- K213620ATUSA™ Automated 3D Breast Ultrasound System2Cleared 510(K)
- K212851EchoSK and EchoSGyn modules for EchoS Family devices2Cleared 510(K)
- K213411iSR’obot Mona Lisa 2.02Cleared 510(K)
- K213303Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-422Cleared 510(K)
- K213070MD-320W Ultrasound Biomicroscope2Cleared 510(K)
- K213254Axialis Ophthalmic Ultrasound System2Cleared 510(K)
- K211726Acuson SC2000 Diagnostic Ultrasound System2Cleared 510(K)
- K212035FibroScan 2302Cleared 510(K)
- K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)2Cleared 510(K)
- K203659iSR'obot Mona Lisa 1.02Cleared 510(K)
- K211193BD Prevue II Peripheral Vascular Vascular Access System2Cleared 510(K)
- K211623THD Procto Software System2Cleared 510(K)
- K210591Palm Bladder Scanner - PBSV7.12Cleared 510(K)
- K211098Breast Volume Navigator (BVN) Model G-20002Cleared 510(K)
- K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)2Cleared 510(K)
- K201316Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)2Cleared 510(K)
- K203719IntraSight Mobile2Cleared 510(K)
- K202119AcuSee AS-P1000 System2Cleared 510(K)
- K201995CUBEScan BioCon-11002Cleared 510(K)
- K201597Liver Incytes, Model 10052Cleared 510(K)
- K200655FibroScan® 6302Cleared 510(K)
- K200980Auto 3D Bladder Volume Tool2Cleared 510(K)
- K200749CUBEScan BioCon-900S2Cleared 510(K)
- K200548CUBEScan BioCon-11002Cleared 510(K)
- K200136Shear Wave Quantificational Ultrasound Diagnostic System2Cleared 510(K)
- K192253SonicEye Dual-Array Ultrasound System2Cleared 510(K)
- K193512THD Procto Software System2Cleared 510(K)
- K192170VistaScan USB Ultrasound Imaging System2Cleared 510(K)
- K192791Diagnostic Ultrasound System2Cleared 510(K)
- K192573Dolphin Medical Imaging USB Ultrasound System2Cleared 510(K)
- K190646QT Scanner 2000 Model A2Cleared 510(K)
- K190314Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 10002Cleared 510(K)
- K191541Vave Personal Ultrasound System2Cleared 510(K)
- K183173LIGHTMED Ultrasound System2Cleared 510(K)
- K191307Palm Bladder Scanner - PBSV5.12Cleared 510(K)
- K190769Bladder Scanner (Models: M2, M2-W, M1, M1-W)2Cleared 510(K)
- K182460MD-6000P Bladder Scanner2Cleared 510(K)
- K190786Eye Prime2Cleared 510(K)
- K190186Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System2Cleared 510(K)
- K183414ABSOLU2Cleared 510(K)
- K190039EchoSure Diagnostic Ultrasound System2Cleared 510(K)
- K182281Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech2Cleared 510(K)
- K182213QT Ultrasound Breast Scanner - 12Cleared 510(K)
- K182153Ultrasound System SONIMAGE HS12Cleared 510(K)
- K181574Uscan2Cleared 510(K)
- K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)2Cleared 510(K)
- K173595Shear Wave Quantificational Ultrasound Diagnostic System2Cleared 510(K)
- K180636ExactVu High Resolution Micro-Ultrasound System2Cleared 510(K)
- K170761LIGHTSonic BUBM2Cleared 510(K)
- K173860s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System2Cleared 510(K)
- K180265COMPACT TOUCH Ophthalmic Ultrasound System2Cleared 510(K)
- K172256SoftVue2Cleared 510(K)
- K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)2Cleared 510(K)
- K180084Ultrasound System SONIMAGE MX12Cleared 510(K)
- K171528Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)2Cleared 510(K)
- K172056InnoSight Diagnostic Ultrasound System2Cleared 510(K)
- K170046Lilium a-200E2Cleared 510(K)
- K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging System2Cleared 510(K)
- K170856CMS600P2 B-Ultrasound Diagnostic System2Cleared 510(K)
- K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)2Cleared 510(K)
- K173138Biim Diagnostic Ultrasound System2Cleared 510(K)
- K172455CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit2Cleared 510(K)
- K171594Accuro2Cleared 510(K)
- K171309BR-FHUS Navigation 1.02Cleared 510(K)
- K172356BladderScan Prime PLUS System2Cleared 510(K)
- K172142FibroScan 430 Mini+2Cleared 510(K)
- K171301Scanmate Flex2Cleared 510(K)
- K171824Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System2Cleared 510(K)
- K171766Acuson SC2000 Diagnostic Ultrasound System2Cleared 510(K)
- K171591CUBEScan™ BioCon-900 (Bladder Volume Measurement System)2Cleared 510(K)
- K161354MELODY, Remote Control System for Ultrasound Probe2Cleared 510(K)
- K162372QT Ultrasound Breast Scanner-12Cleared 510(K)
- K170133FFR V2.52Cleared 510(K)
- K170385CORE M2 Vascular System2Cleared 510(K)
- K162972ExactVu High Resolution Micro-Ultrasound System2Cleared 510(K)
- K161968MicrUs2Cleared 510(K)
- K161342Sonic Window2Cleared 510(K)
- K161300Acclarix AX8 Diagnostic Ultrasound System2Cleared 510(K)
- K153620Enovare Ultrasound System2Cleared 510(K)
- K160792Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound2Cleared 510(K)
- K153581Bladder Scanner2Cleared 510(K)
- K160420SpeqT2Cleared 510(K)
- K160524FibroScan 530 Compact2Cleared 510(K)
- K153416ArcScan Insight 1002Cleared 510(K)
- K153369SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz2Cleared 510(K)
- K152554Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology2Cleared 510(K)
- K1525734Sight2Cleared 510(K)
- K153101BladderScan Prime System2Cleared 510(K)
- K152318MD-2300S Ultrasonic A/B Scanner for Ophthalmology2Cleared 510(K)
- K152316iLab Ultrasound Imaging System2Cleared 510(K)
- K151339SONON Ultrasound Imaging System (Model: SONON 300C)2Cleared 510(K)
- K150239FibroScan2Cleared 510(K)
- K151709Hi-Light Diagnostic Ultrasound Systems2Cleared 510(K)
- K151060Ultrasound System SONIMAGE HS12Cleared 510(K)
- K150949FibroScan2Cleared 510(K)
- K150342Touch Ultrasound2Cleared 510(K)
- K150999Acclarix Diagnostic Ultrasound System2Cleared 510(K)
- K150580UltraVision 2 Diagnostic Ultrasound System2Cleared 510(K)
- K150529Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System2Cleared 510(K)
- K150441Volcano iFR Modality, iFR Scout feature2Cleared 510(K)
- K143122Volcano iFR Harvest Software (Offline)2Cleared 510(K)
- K143396omni TRAX Active Patient Tracker2Cleared 510(K)
- K143493SignosRT Bladder Ultrasound System2Cleared 510(K)
- K142329BBS REVOLUTION2Cleared 510(K)
- K142517SoftVue2Cleared 510(K)
- K142443Site-Rite 6 Ultrasound System with Pinpoint GT Technology2Cleared 510(K)
- K142054IMACOR ZURA EVO IMAGING SYSTEM2Cleared 510(K)
- K141806CLEAR GUIDE ONE2Cleared 510(K)
- K142395SC2000 and ACUSON X300 Diagnostic Ultrasound Systems2Cleared 510(K)
- K140428ULTRASOUND SCANNER SYSTEM BK23002Cleared 510(K)
- K140899HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEM2Cleared 510(K)
- K140199VUPAD2Cleared 510(K)
- K133323VOLCANO IFR MODALITY2Cleared 510(K)
- K132736ACCURO 3000 ULTRASOUND SCANNER2Cleared 510(K)
- K140291VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS2Cleared 510(K)
- K140126SONIC WINDOW2Cleared 510(K)
- K132346ULTRASOUND SCANNER PRO FOCUS 22022Cleared 510(K)
- K133641CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE2Cleared 510(K)
- K123209SOFTVUE2Cleared 510(K)
- K133142VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION2Cleared 510(K)
- K132654ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K131830DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM2Cleared 510(K)
- K132228UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K131690M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K131227PADSCAN HD SERIES BLADDER SCANNER2Cleared 510(K)
- K131489TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION2Cleared 510(K)
- K130944ISR'OBOT MONA LISA2Cleared 510(K)
- K121243ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER2Cleared 510(K)
- K123806FIBROSCAN2Cleared 510(K)
- K130229PALM BLADDER SCANNER2Cleared 510(K)
- K130243ILAB ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
- K123349A-SCAN PLUS CONNECT2Cleared 510(K)
- K123535ILAB ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
- K123898VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM2Cleared 510(K)
- K123616PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM2Cleared 510(K)
- K123185DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K122574DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL D3 AND D62Cleared 510(K)
- K121689VITASCAN LT SCANMASTER2Cleared 510(K)
- K121479AIM2Cleared 510(K)
- K121422APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K121888E-CUBE 152Cleared 510(K)
- K111818SONIXGPS NEEDLE SENSOR2Cleared 510(K)
- K121381VIEWFLEX XTRA ICE CATHETER2Cleared 510(K)
- K120882SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE2Cleared 510(K)
- K120201GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
- K113304BLADDER SCANNER2Cleared 510(K)
- K112539CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE2Cleared 510(K)
- K113486VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM2Cleared 510(K)
- K113632DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM2Cleared 510(K)
- K113680SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT2Cleared 510(K)
- K113153DP-20 AND DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM2Cleared 510(K)
- K113156SONOSITE EDGE ULTRASOUND SYSTEM2Cleared 510(K)
- K112022DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM2Cleared 510(K)
- K111347ISROBOT MONA LISA2Cleared 510(K)
- K111706VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM2Cleared 510(K)
- K111435DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM2Cleared 510(K)
- K110688MYLABGOLD2Cleared 510(K)
- K102253ECHO BLASTER2Cleared 510(K)
- K103148AIDA DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K102153MOBIUS ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
- K103608I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND2Cleared 510(K)
- K102027AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM2Cleared 510(K)
- K102393VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM2Cleared 510(K)
- K102198COMPACT TOUCH STS2Cleared 510(K)
- K102991M5 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K101149GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
- K101337A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM2Cleared 510(K)
- K101429ECO SUPERGEL2Cleared 510(K)
- K093466HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS2Cleared 510(K)
- K100363ULTRA DCI MODEL 50002Cleared 510(K)
- K094038COMPACT TOUCH2Cleared 510(K)
- K100252MASTER-VU A-SCAN, MV45002Cleared 510(K)
- K093371MODEL DGH 6000 SCANMATE A2Cleared 510(K)
- K093485VESISCAN2Cleared 510(K)
- K100079DIGITAL ULTRASOUND SCANNER2Cleared 510(K)
- K092837OTI-SCAN 30002Cleared 510(K)
- K093488ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K092619ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER2Cleared 510(K)
- K092182VOYAGER COMPACT IMAGING SYSTEM2Cleared 510(K)
- K090773CFI ULTRASOUND PROBE DRAPE2Cleared 510(K)
- K092140GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND2Cleared 510(K)
- K083728INVISION SYSTEM2Cleared 510(K)
- K091518CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K091374GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND2Cleared 510(K)
- K090505SPEQ ULTRASOUND SYSTEM2Cleared 510(K)
- K090059IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K090214VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND2Cleared 510(K)
- K083061ELLEX INNOVATIVE IMAGING EYE CUBED V42Cleared 510(K)
- K081148SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER2Cleared 510(K)
- K082456VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 96002Cleared 510(K)
- K082543SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 1002Cleared 510(K)
- K082229S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM2Cleared 510(K)
- K082185GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-22Cleared 510(K)
- K080930MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS2Cleared 510(K)
- K081873EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE2Cleared 510(K)
- K081781NUWAV2Cleared 510(K)
- K080223ZURA TEE SYSTEM2Cleared 510(K)
- K081121MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM2Cleared 510(K)
- K081154ULTRASOUND SCANNER FLEX FOCUS, MODEL 12022Cleared 510(K)
- K081110SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
- K080234TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO2Cleared 510(K)
- K080049VASCUVIEW ULTRASOUND SYSTEM2Cleared 510(K)
- K073196MASTER-VU2Cleared 510(K)
- K072676ACUSON X300 ULTRASOUND SYSTEM2Cleared 510(K)
- K072797GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND2Cleared 510(K)
- K072517ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.32Cleared 510(K)
- K072210CHISON, MODEL 83002Cleared 510(K)
- K071996MYLAB30, MODEL 73002Cleared 510(K)
- K071156SOUNMED SD-2000 PLUS PORTABLE ULTRASOUND SCANNER2Cleared 510(K)
- K071314SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS2Cleared 510(K)
- K071204SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 62Cleared 510(K)
- K071217BLADDERSCAN BVI 9400 ULTRASOUND2Cleared 510(K)
- K071134SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K070982CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
- K070943B-SCAN PLUS2Cleared 510(K)
- K070907INTERSON USB ULTRASOUND PROBE SYSTEM2Cleared 510(K)
- K070884POD B-SCAN2Cleared 510(K)
- K070526DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM2Cleared 510(K)
- K070477ORISON EMBRACE SYSTEM2Cleared 510(K)
- K070077ULTRASOUND SCANNER PROFOCUS, MODEL 22022Cleared 510(K)
- K063472ULTRASONIC BIOMETER/ PACHYMETER FOR OPHTHALMOLOGY, MODEL ODM 2100, 22002Cleared 510(K)
- K063433ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 22002Cleared 510(K)
- K062571LONGPORT EPISCAN, MODEL-I-2002Cleared 510(K)
- K063085MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM2Cleared 510(K)
- K061215VOLCANO S51 FAMILY OF IMAGING SYSTEMS2Cleared 510(K)
- K061755MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM2Cleared 510(K)
- K061641ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO2Cleared 510(K)
- K061682GE VOLUSON E8 ULTRASOUND SYSTEM2Cleared 510(K)
- K060483VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM2Cleared 510(K)
- K061083CTS-77002Cleared 510(K)
- K061189DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM2Cleared 510(K)
- K060949DP-6600 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM2Cleared 510(K)
- K053306IVIEW2Cleared 510(K)
- K060626VUMAX2Cleared 510(K)
- K060800SEEKER/SPARK ULTRASOUND SYSTEM2Cleared 510(K)
- K053346MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-99002Cleared 510(K)
- K053325MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M00012Cleared 510(K)
- K052348IN VISION GOLD WITH SPIN VISION, MODEL 891 SV2Cleared 510(K)
- K052355AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS2Cleared 510(K)
- K051920VOLCANO S5 IMAGING SYSTEM, MODEL 804200-0012Cleared 510(K)
- K052113DP-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM2Cleared 510(K)
- K051851AVISO OPHTHALMIC ULTRASOUND SYSTEM2Cleared 510(K)
- K051500FAMIO DIAGNOSTIC ULTRASOUND SYSTEMS, MODEL SSA-530A2Cleared 510(K)
- K051304ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM2Cleared 510(K)
- K050980ULTRASONIC BIO-MICROSCOPE, MODEL P602Cleared 510(K)
- K050552PACHPEN PACHYMETER, MODEL 24-51002Cleared 510(K)
- K050551VOYAGER PERSONAL IMAGING DEVICE2Cleared 510(K)
- K043189SONALIS, MODEL 20002Cleared 510(K)
- K050167CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE2Cleared 510(K)
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- K042620SONATA 3-D IMAGING ACCESSORY, MODEL 3DS2Cleared 510(K)
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- K042250SENSATOUCH2Cleared 510(K)
- K042752ACCUPACH V2Cleared 510(K)
- K042188VOLCANO THERAPEUTICS, INC. VOLCANO IVUS SYSTEM2Cleared 510(K)
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- K042540PHILIPS IU22 ULTRASOUND SYSTEM2Cleared 510(K)
- K041639TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM2Cleared 510(K)
- K041947I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND2Cleared 510(K)
- K041455SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
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- K023473SONOREAL 3D2Cleared 510(K)
- K023457ULTRASOUND SCANNER, TYPE 11012Cleared 510(K)
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- K020561SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN2Cleared 510(K)
- K020876ECHOSCAN, MODEL US-18002Cleared 510(K)
- K02011250S TRINGA ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
- K020151UD-1000 ULTRASONIC A/B SCANNER2Cleared 510(K)
- K012803AL-2000 COMBINED BIOMETER AND PACHYMETER2Cleared 510(K)
- K013088ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS2Cleared 510(K)
- K020068SONOREAL 3D SYSTEM2Cleared 510(K)
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- K012772CTS-485 ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
- K012084SONOREAL 3D2Cleared 510(K)
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- K012253SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
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- K994385BABY FACE2Cleared 510(K)
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- K993394ECHO SCAN, EASY SCAN2Cleared 510(K)
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- K993365GE LOGIQ 700 WITH HARMONIC IMAGING MODIFICATION2Cleared 510(K)
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- K992046SONOLINE 7XX DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
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- K991842SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING2Cleared 510(K)
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- K991710SSA-370A/POWERVISION 60002Cleared 510(K)
- K990560LIFE IMAGING SYSTEMS, MODEL L3DI2Cleared 510(K)
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- K990248DICOM IMAGE MANAGER, MODEL 3-D VISUALIZATION OPTION2Cleared 510(K)
- K983879ALOKA SSD-900 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K983945CORTEX DERMASCAN C ULTRASONIC SYSTEM2Cleared 510(K)
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- K981404FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-45002Cleared 510(K)
- K981510SONOACE 6000/ ULTRAMARK 4002Cleared 510(K)
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- K980308ECHOTECH 3D FREESCAN2Cleared 510(K)
- K980851GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I50282Cleared 510(K)
- K980860HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K973802SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K9745223D I-SCAN2Cleared 510(K)
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- K973767HARMONIC IMAGING WITH CONTRAST2Cleared 510(K)
- K970901GE LOGIQ 500 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K972192PERCEPTION INC. GPS-XYZ DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K971528ENDOSCOPICALLY DELIVERALBE ULTRASOUND POINT PORBE SYSTEM (ENDOSCOPY)2Cleared 510(K)
- K973450SENSOR PAD2Cleared 510(K)
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- K962882SONOLINE VERSA PRO DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K963863JANUS I2Cleared 510(K)
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- K963315VINGMED SOUND COLOR FLOW MAPPING SYSTEM. SYSTEM FIVE2Cleared 510(K)
- K961073ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE)2Cleared 510(K)
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- K955543ULTRASOUND SYSTEM MODEL UF-35002Cleared 510(K)
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- K960765MENTOR ADVENT A/B SYSTEM2Cleared 510(K)
- K951976ECHO. AKHO2Cleared 510(K)
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- K930964ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)2Cleared 510(K)
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- K930579MEDISON 88P DIAGNOSTIC ULTRASOUND IMAGING SYTEM2Cleared 510(K)
- K926252CATHSCANNER II INTRAVASCULAR ULTRASONIC IMAGING SY2Cleared 510(K)
- K925627ADDITIONAL FEATURES ESI-3000 ULTRASOUND UNIT2Cleared 510(K)
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- K926009MATRIX CCM 6002Cleared 510(K)
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- K924231INTERSPEC APOGEE CLA2Cleared 510(K)
- K930324EZ MOVER2Cleared 510(K)
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- K925646SSD-2000 DIAG. ULTRASOUND SYS.&UST-979-3.5 TRANS.2Cleared 510(K)
- K924458AI5200 DIAG ULTRA SOUND SYST INCLUD 7.5 & 10.0 MHZ2Cleared 510(K)
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- K923269CONVEX AND LINEAR ARRAY TRANSDUCERS2Cleared 510(K)
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- K920906DGH-500 PACHYMETER2Cleared 510(K)
- K922604DELUXE ADJUSTABLE HEIGHT ULTRASOUND TABLE2Cleared 510(K)
- K922605TRENDELENBURG ULTRASOUND TABLE, MODEL # 056-6032Cleared 510(K)
- K904070COMBISON(R) 330, MODEL # IR17.5AG/A & VRW177AK/A2Cleared 510(K)
- K921426ULTRA PCI2Cleared 510(K)
- K922647COLOR DISKSTORE2Cleared 510(K)
- K915715CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER2Cleared 510(K)
- K914945DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED2Cleared 510(K)
- K921670ACUSON IMAGE MANAGEMENT SYSTEM2Cleared 510(K)
- K920373MAESTRO DIGITAL VIDEO SYSTEM2Cleared 510(K)
- K920374ALOKA 650CL DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K915436BLADDERSCAN BVI 25002Cleared 510(K)
- K913067DGH-4000 A-SCAN/PACHYMETER2Cleared 510(K)
- K914013SIEMENS SI-4002Cleared 510(K)
- K911584DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC4802Cleared 510(K)
- K911464INTERSON DISPOSABLE BIOPSY NEEDLE2Cleared 510(K)
- K910956COMPUSCAN LT BIOMETRIC RULER AND IOL CALCULATOR2Cleared 510(K)
- K910342SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
- K911200SI-1200 / ILUS2Cleared 510(K)
- K905522LABSONICS MAMM-O-MATE MODEL NO. 918084-1, MODIFIED2Cleared 510(K)
- K911107SONARSCAN 128 ULTRASOUND SCANNER2Cleared 510(K)
- K904853MODEL STT-1002Cleared 510(K)
- K904019QUANTUM 2000 ANGIODYNOGRAPH ULTRASOUND SYSTEM2Cleared 510(K)
- K903603ULTRAMARK 9 ULTRASOUND SYSTEM (UM 9)2Cleared 510(K)
- K905294EUB-3152Cleared 510(K)
- K896100EUB-565 DIAGNOSTIC ULTRASOUND DEVICE2Cleared 510(K)
- K904692DB 3000 A-SCAN SYSTEM2Cleared 510(K)
- K903326NIDEK US-20002Cleared 510(K)
- K902214BIOPSY NEEDLE TRANSPONDER SYSTEM2Cleared 510(K)
- K902411NIDEK US-2500 W/BIOMETRY UNIT US-25202Cleared 510(K)
- K902965FDI 2000 ULTRASONIC SKIN SCANNER2Cleared 510(K)
- K900881OR-340 INTRAOPERATIVE ULTRASOUND SYSTEM2Cleared 510(K)
- K897042EUB-515 DIAGNOSTIC ULTRASOUND DEVICE2Cleared 510(K)
- K901467VISION DIAGNOSTIC ULTRASONIC SCANNER2Cleared 510(K)
- K900805ALOKA 500 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM2Cleared 510(K)
- K901033MER MULTIPLANE RECTAL PROBE (MRP)2Cleared 510(K)
- K896356AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM2Cleared 510(K)
- K902582ALLERGAN HUMPHREY A/B SCAN , MODEL 8352Cleared 510(K)
- K896999SDL 310 DIAGNOSTIC ULTRASOUND INSTRUMENT2Cleared 510(K)
- K902007I3SYSTEM-ABD2Cleared 510(K)
- K896480SIEMENS SONOLINE AC2Cleared 510(K)
- K900469ULTRASOUND SCANNER MODEL #11502Cleared 510(K)
- K896714AUSONICS 50002Cleared 510(K)
- K896755ALOKA 680 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM2Cleared 510(K)
- K884644ADDIT. TRANS. EUP-B31/033J/V33/U33/032T/L33/U3222Cleared 510(K)
- K896173ULTRASCAN(R)2Cleared 510(K)
- K895645BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K895147QUANTUM QAD-1E ANGIODYNOGRAPH ULTRASOUND SYSTEM2Cleared 510(K)
- K896150IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONIC2Cleared 510(K)
- K896029DIGITAL ULTRASOUND IMAGING SYSTEM DUB 202Cleared 510(K)
- K895614CIVCO LATEX ULTRASOUND SHEATHS2Cleared 510(K)
- K895071AI5200 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCER2Cleared 510(K)
- K893225COUPLANT WARMING DEVICE2Cleared 510(K)
- K894806SIEMENS ENDO-P-PROBE2Cleared 510(K)
- K891449SONOLINE CF2Cleared 510(K)
- K894834DERMASCAN C, AN ULTRASONIC DIAGNOSTIC SYSTEM2Cleared 510(K)
- K893996CUSIS ULTRASOUND SKIN IMAGING SYSTEM2Cleared 510(K)
- K892386DIAGNOSTIC ULTRASOUND SYSTEM: MODEL SSA-250A2Cleared 510(K)
- K890913SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT2Cleared 510(K)
- K893837CVIS ULTRA-SCAN ONE IMAGING CATHETER2Cleared 510(K)
- K890275ACUSON S328 TRANSDUCER FOR FETAL CARDIAC PULSED2Cleared 510(K)
- K884271ACUSON S328 TRANSDUCER FOR FETAL PULSED DOPPLER2Cleared 510(K)
- K892355M1300A ULTRASOUND IMAGING SYSTEM, M1321A 3.5 MHZ2Cleared 510(K)
- K890963SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/42Cleared 510(K)
- K893035OPHTHASCAN 'S' MINI-A2Cleared 510(K)
- K891452SPECTRA ULTRASOUND SYSTEM W/COLOR FLOW MODULE2Cleared 510(K)
- K891453DIAGNOSTIC ULTRASOUND TRANSDUCER: PVE-582V2Cleared 510(K)
- K891225OPTIONAL PROBE OF CANON IOL ESTIMATOR KU-12Cleared 510(K)
- K8913095.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER2Cleared 510(K)
- K891386CVIS ULTRA-SCAN ONE IMAGING SYSTEM2Cleared 510(K)
- K890969TRANSESOPHAGEAL TRANSDUCER PEF-511SA2Cleared 510(K)
- K890772ULTRASONIC IMAGING CATHETER FOR CARDIAC APPLI.2Cleared 510(K)
- K890519LABSONICS MAMM-O-MATE MODEL NO. 918084-12Cleared 510(K)
- K890173INTERSPEC APOGEE2Cleared 510(K)
- K883917NATURAL IMAGE ULTRASOUND TRANSMISSION COUPLANT2Cleared 510(K)
- K885228RT6800 ECHOCARDIOGRAPHY SYSTEM2Cleared 510(K)
- K881336BRYMASCAN-A2Cleared 510(K)
- K883359DIAGNOSTIC ULTRASOUND SYSTEM SSA-270A2Cleared 510(K)
- K884632ACUSON I5100 ULTRASOUND TRANSDUCER2Cleared 510(K)
- K884395HP 21362B TRANSESOPHAGEAL ULTRASOUND IMAGING TRANS2Cleared 510(K)
- K884299APA-C CATALOG NUMBER A-8001-C2Cleared 510(K)
- K884595OPHTHASCAN MINI-B2Cleared 510(K)
- K883925UROIMAGER2Cleared 510(K)
- K883079WWDS-005 HUMAN RECTAL PROBE2Cleared 510(K)
- K875187SDU-500 DIAGNOSTIC ULTRASOUND INSTRUMENT2Cleared 510(K)
- K883752ACUSON L538 TRANSDUCER2Cleared 510(K)
- K881140ULTRAMARK 4+ ULTRASOUND W/3.5 MHZ 40R CONVEX ARRAY2Cleared 510(K)
- K883481HP 77025A/77030A ULTRA. SYSTEM/HP 77020CV UPGRADE2Cleared 510(K)
- K882478100-01778-52 ULTRASOUND SYSTEM2Cleared 510(K)
- K883546TEEC (TRANSESOPHAGEAL ECHOCARDIOGRAPHY) TRANSDUCER2Cleared 510(K)
- K883965PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR2Cleared 510(K)
- K881889CANON IOL ESTIMATOR KU-12Cleared 510(K)
- K881850TEKNAR PERCU-SCAN2Cleared 510(K)
- K874854GPS/WGPS/PREVIEW GP2Cleared 510(K)
- K883238GENESIS II TRANSCRANIAL PROBE2Cleared 510(K)
- K881834MODEL SSD-870 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
- K882162NIDEK US-30002Cleared 510(K)
- K882959ENDOVAGINAL PROBE, SMS-510VA2Cleared 510(K)
- K882805CILCO VILLASENOR PACHYMETER2Cleared 510(K)
- K873452MODIFIED MODEL SSD-650 SYSTEM2Cleared 510(K)
- K874192MULTIPURPOSE TRANSDUCER RANGE2Cleared 510(K)
- K875357BIOPSY FIXATION UNIT-TYPE UA 09972Cleared 510(K)
- K874211EUB-450 DIAGNOSTIC ULTRASOUND DEVICE2Cleared 510(K)
- K881605BIOPSY GUIDE2Cleared 510(K)
- K874028ACUSON S328 TRANSDUCER2Cleared 510(K)
- K880839AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K880580EXTENDED MULTIPURPOSE TRANSDUCER RANGE2Cleared 510(K)
- K881208PROBE SHEATH FOR ADMS ULTRASOUND PROBE2Cleared 510(K)
- K875251ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE2Cleared 510(K)
- K874363ACUSON S228 AND S328 TRANSDUCERS FOR ABDOM. APPLI.2Cleared 510(K)
- K8810287.5 MHZ ENDORECTAL PROBE2Cleared 510(K)
- K874684TC2-64B TRANSCRANIAL DOPPLER2Cleared 510(K)
- K874685TRANS-SCAN 3-D TRANSCRANIAL DOPPLER2Cleared 510(K)
- K880714DIASONICS QT ENDORECTAL 7.5 MHZ PROBE2Cleared 510(K)
- K874683THE ESI-2000 ULTRASOUND UNIT2Cleared 510(K)
- K874548SIM 4000C2Cleared 510(K)
- K875236TRANS/P NEEDLE GUIDE2Cleared 510(K)
- K875240TRANS/V NEEDLE GUIDE2Cleared 510(K)
- K875128TRANS/R NEEDLE GUIDE2Cleared 510(K)
- K880659TEKNAR PROSCAN ACCESSORY PROBE2Cleared 510(K)
- K875241CIVCO SEED IMPLANT NEEDLE GUIDE2Cleared 510(K)
- K873845SIM 4000I2Cleared 510(K)
- K880219TRANSRECTAL PROBE BD65S-TR2Cleared 510(K)
- K873937SDR 3500 (PHILIPS PLATINUM +)2Cleared 510(K)
- K880081VISION CARE/PHAKOSYSTEMS ECHOPACH2Cleared 510(K)
- K880065NIDEK UP-20002Cleared 510(K)
- K873159COMBISON(R) 310A REAL TIME ULTRASOUND SCANNER2Cleared 510(K)
- K872288SONOLAYER-V, SAL-38B2Cleared 510(K)
- K871004EUB-410 DIAGNOSTIC ULTRASOUND DEVICE2Cleared 510(K)
- K872726DGH-3000A A-SCAN2Cleared 510(K)
- K873096COLOR FLOW IMAGING2Cleared 510(K)
- K871938VISION CARE/PHAKOSYSTEMS ECHORULE2Cleared 510(K)
- K872307VOLUMETRIC PACKAGE STEPPER H4222AA/CALCU. H4222AB2Cleared 510(K)
- K871536OPHTHASONIC A-SCAN/ B-SCAN2Cleared 510(K)
- K854654SM PART SERVO SEC. DUPLEX DOP 7-5/5 9814-219-500072Cleared 510(K)
- K872027OLYMPUS GF-UM2/EU-M22Cleared 510(K)
- K864807TEKNAR PROSCAN(TM)2Cleared 510(K)
- K870964ESI-1002 SYSTEM AND DC100S/C50M-P TRANSDUCER2Cleared 510(K)
- K860581QAD-1 ANGIODYNOGRAPH ULTRASOUND SYSTEM2Cleared 510(K)
- K864336PACHYMETER SYSTEM V2Cleared 510(K)
- K863947SONOLAYER-L, SAL-77B2Cleared 510(K)
- K862867EUB-310 ULTRASONIC SCANNER2Cleared 510(K)
- K863780ADA-1000 (ADVANCED DIGITAL ARRAY)2Cleared 510(K)
- K864398STORZ SOLID & ANGLED SOLID CONTACT PROBES2Cleared 510(K)
- K860757OPHTHASONIC A-SCAN2Cleared 510(K)
- K863576EUB-400 DIAGNOSTIC ULTRASOUND DEVICE2Cleared 510(K)
- K862127DYMAX PERSONAL SCANNER2Cleared 510(K)
- K862165ELECTRONIC ULTRASOUND SCANNER, MODEL EUB-3402Cleared 510(K)
- K8633387.5 MHZ LINEAR SMALL PARTS PROBE2Cleared 510(K)
- K8630965.O MHZ SECTOR PROBE, MODEL 8818106 LH 3072Cleared 510(K)
- K8630433.5 MHZ SECTOR PROBE, MODEL 8818080 LH 3052Cleared 510(K)
- K8630413.5 MHZ SECTOR PROBE, MODEL 8818098 LH3062Cleared 510(K)
- K862164EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER2Cleared 510(K)
- K852502AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/18492Cleared 510(K)
- K862151COLOR FLOW MAPPING (CFM) OPTION - MODEL 77020 CF2Cleared 510(K)
- K854653CILCO SONOMETRICS DIGICON2Cleared 510(K)
- K861538860 COLOR DOPPLER OR COLORVIEW 8602Cleared 510(K)
- K862166SONORANGER2Cleared 510(K)
- K860697ULTRASOUND IMAGING SYSTEM MODEL 280 SL2Cleared 510(K)
- K862681ULTRAMARK 1 ULTRASOUND SYSTEM2Cleared 510(K)
- K8601235.0 MHZ INTRAOPERATIVE ARRAY2Cleared 510(K)
- K861376COMBISON R 320A2Cleared 510(K)
- K861335STORZ COMPUSCAN 68K2Cleared 510(K)
- K853565ARTIS ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
- K860081ESI 2000 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCERS2Cleared 510(K)
- K854959LINEAR SCANNER PROBE, MODEL TL-502Cleared 510(K)
- K854389NIDEK US-1600 A-SCAN2Cleared 510(K)
- K8546685.0 MHZ LINEAR ARRAY SONOLINE PROBE2Cleared 510(K)
- K8546677.5 MHZ LINEAR ARRAY SONOLINE PROBE2Cleared 510(K)
- K853147SCANO 731B & 731C ULTRASOUND SOFT TIS DEPT MEAS SY2Cleared 510(K)
- K855124CONVEX PROBE, PVE-382M2Cleared 510(K)
- K854555GL590 DIAGNOSTIC ULTRASOUND EQUIPMENT2Cleared 510(K)
- K860061OCULAB BIOMETRICPEN2Cleared 510(K)
- K860062OCULAB PACHPEN2Cleared 510(K)
- K852686SONOLINE CD2Cleared 510(K)
- K8547432.5 MHZ PHASED ARRAY SECTOR MERIDIAN PROBE2Cleared 510(K)
- K854969CILCO SONOMETRICS A&B DIGITAL SYSTEM (DIGISCAN)2Cleared 510(K)
- K853739SONOLAYER SAL-55A/55AS2Cleared 510(K)
- K853702ULTRASOUND COUPLANT SHEET/SOLID ULTRASOUND COUPLAN2Cleared 510(K)
- K852862CORNEO-GAGE TWO2Cleared 510(K)
- K853946SONOLINE LX2Cleared 510(K)
- K844112MYOPACH ULTRASONIC PACHOMETER2Cleared 510(K)
- K853008SONOLINE SL-2(ULTRASOUND SCANNER)2Cleared 510(K)
- K851972DIASONICS ADA400 ADVANCED DIGITAL ARRAY2Cleared 510(K)
- K853217QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES2Cleared 510(K)
- K854135HEWLETT PACKARD ULTRASOUND TRANSDUCER 21230A2Cleared 510(K)
- K853311LINEAR ARRAY PROBE PLB-310M FOR SAL-32B2Cleared 510(K)
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- K852362UROLOGICAL ULTRASOUND DIAGNOSTIC SYS/EQUIP. SSD-522Cleared 510(K)
- K851860DIASONICS DRF-200 ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
- K851446UNIVERSAL SERVICE MODULE2Cleared 510(K)
- K850834SDL-32 ELECTRONIC LINEAR SCANNER2Cleared 510(K)
- K853087STORZ SOLID-STANDOFF PACHYMETRY PROBE2Cleared 510(K)
- K851895POLYGEL ULTRASOUND GEL2Cleared 510(K)
- K8525705.0 MHZ LINEAR ARRAY, MODEL 83, 39, 5172Cleared 510(K)
- K8525713.5 MHZ LINEAR ARRAY, MODEL NO. 83, 39, 5092Cleared 510(K)
- K851807RT2600(115V)(220/240V) #H4008A & H4008AE2Cleared 510(K)
- K844686OPHTHASCAN B2Cleared 510(K)
- K844184D300 PORT ULTRASOUND LIN SCAN W/3.5 & 5.0 MHZ PROB2Cleared 510(K)
- K852549SONORANGER2Cleared 510(K)
- K851982KITECKO ULTRASOUND STANDOFF PAD2Cleared 510(K)
- K851696AUSONICS 1502Cleared 510(K)
- K844916MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER2Cleared 510(K)
- K850290ULTRASOUND GEL2Cleared 510(K)
- K844299CORNEOMAP 45002Cleared 510(K)
- K843994AUSONICS 3572Cleared 510(K)
- K843971AUSONICS 1502Cleared 510(K)
- K850478PLUS 12Cleared 510(K)
- K844393GL ULTRASOUND SECTOR 1702Cleared 510(K)
- K850580DIAGNOSTIC ULTRASOUND SYS MODEL ULS10002Cleared 510(K)
- K850116BETASONIC III2Cleared 510(K)
- K843696OPHTHALMIC A-SCAN A-2000 SONOME2Cleared 510(K)
- K843205GL ULTRASOUND Z/SL 83002Cleared 510(K)
- K844404IREX PS, PORTABLE SCANNER AND 1182Cleared 510(K)
- K844477STORZ CORNEO-SCAN II CS20002Cleared 510(K)
- K844472CIVCO SCAN DRAPE2Cleared 510(K)
- K844449HIGH RESOLUTION 5 MHZ LINEAR ARRAY2Cleared 510(K)
- K843891DOPSCAN PLUS DS10602Cleared 510(K)
- K842757ULTRASCAN DIGITAL B2Cleared 510(K)
- K843320RT-502Cleared 510(K)
- K842900PHILIPS SDR 12002Cleared 510(K)
- K842880MECHANICAL SECTOR PROBE 4 MHZ DFM2Cleared 510(K)
- K842777AUTOFOCUS DUAL ELEMENT PROBE2Cleared 510(K)
- K842376ULTRAMARK 4 ULTRASOUND SYS2Cleared 510(K)
- K842093MK 700 ULTRASOUND SYSTEM2Cleared 510(K)
- K842897MEDICAL DIAG. ULTRASOUND INSTR. 770652Cleared 510(K)
- K843167SONIC AID GREEN ULTRASOUND GEL2Cleared 510(K)
- K842811ULTRASYSTEM LINSCAN PROBE2Cleared 510(K)
- K842127AMERICAN MEDICAL OPTICS IMAGING SYS2Cleared 510(K)
- K841817TECHNICARE 248 SL & 260SL2Cleared 510(K)
- K842591ULTRASOUND PROBE COVERS-STERILE2Cleared 510(K)
- K842153ULTRASOUND TRANSMISSION GEL2Cleared 510(K)
- K841332CIVCO/SUPER SCAN2Cleared 510(K)
- K840540TECHNICARE MODEL 3302Cleared 510(K)
- K840451BIOPSY ATTACHMENT;DYNEX ULTRASOUND-2Cleared 510(K)
- K840139IREX 720 SECTOR SCANNER2Cleared 510(K)
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- K833667DIASONICS DLA-1002Cleared 510(K)
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- K840138QTA PROCESSOR MODULE2Cleared 510(K)
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- K834282ULTRA IMAGER 20002Cleared 510(K)
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- K834486TECHNICARE 2802Cleared 510(K)
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- K810660KREMER CORNEOMETER ULTRASONIC PACHOMETER2Cleared 510(K)
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- K811426ARTICULATED ARM B-SCANNER2Cleared 510(K)
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- K810945SCANEL 1002Cleared 510(K)
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- K810038DIGITAL DIAGNOSTIC ULTRASOUND DEVICE2Cleared 510(K)
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- K802759SIEMENS PHO/SONIC ALPHA 10002Cleared 510(K)
- K802708SYSTEM, ECHO, PULSED ULTRASONIC DIAG.2Cleared 510(K)
- K802695DATASON RTL II2Cleared 510(K)
- K802532PFIZONIC 300 ULTRASOUND SCANNER2Cleared 510(K)
- K802531PFIZONIC 200 ULTRASOUND SCANNER2Cleared 510(K)
- K802530PFIZONIC 250 ULTRASOUND SCANNER2Cleared 510(K)
- K802528PFIZONIC 150 ULTRASOUND SCANNER2Cleared 510(K)
- K801954HP MODEL 77020A ULTRASOUND SYSTEM2Cleared 510(K)
- K802704SIAM 80-INSTANTANEOUS SONOGRAPH W/STOR.2Cleared 510(K)
- K802341DIOSCAN2Cleared 510(K)
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- K802263MINIVISOR TERMINAL2Cleared 510(K)
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- K801844SONIA-SO NOGRAPH-NUMERICAL ANALYSIS2Cleared 510(K)
- K801454DATASON RTL2Cleared 510(K)
- K801598MARK V DUPLEX ULTRASONIC SCANNING SYSTEM2Cleared 510(K)
- K801406MARK III ULTRASONIC SCANNING SYSTEM2Cleared 510(K)
- K801060HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNE2Cleared 510(K)
- K801056EDP 1200 ULTRASONIC B-SCANNER2Cleared 510(K)
- K800824MODEL SKI-200 ABDOMINAL SCANNER2Cleared 510(K)
- K800652MODEL E03 ECHO-OPTHALMOSCOPE2Cleared 510(K)
- K8001014200 ME ECHOENCEPHALOGRAPH2Cleared 510(K)
- K800532S.K. DIAG. ULTRASOUND BODY SCANNER2Cleared 510(K)
- K800531S.K. DIAG. ULTRASND. SMALL PARTS SCAN2Cleared 510(K)
- K800434PORTABLE MEDICAL ULTRASOUND SCANNER2Cleared 510(K)
- K800099INTRACULA II2Cleared 510(K)
- K8001007200 MA ECHO-OPHTHALMOSCOPE2Cleared 510(K)
- K791766ECHO-OCULOMETER #30002Cleared 510(K)
- K800139SEARLE PHO/SONIC ALPHA 20002Cleared 510(K)
- K800094COMBISON 200 & COMBISON 2022Cleared 510(K)
- K800091COMBISON 100-MODEL 100 & 1102Cleared 510(K)
- K792489UCA CREAM2Cleared 510(K)
- K792492UCA GEL2Cleared 510(K)
- K792638HIGH RESOLUTION IMAGING SYSTEM2Cleared 510(K)
- K792585SMV 120 SONIC MAMMOGRAPHIC VIEWER2Cleared 510(K)
- K792446ADR REAL-TIME SECTOR SCANNER2Cleared 510(K)
- K792388OCTOSON2Cleared 510(K)
- K791775VARIAN V-3300, PHASED ARRAY ULTRASON2Cleared 510(K)
- K791744VARIAN V-3400, PHASED ARRAY ULTRASON2Cleared 510(K)
- K791755DATASON-GS2Cleared 510(K)
- K791040SECTOR SCANNER, SDU-100, COMPUTERIZED2Cleared 510(K)
- K791298DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K791429EMISONIC 42902Cleared 510(K)
- K791505ROHNAR 7000 DIGITAL DIAGN ULTRASOUND2Cleared 510(K)
- K791344MODEL 1350 GRAPHICS TRANSLATOR2Cleared 510(K)
- K791343MODEL 1338A CRT DISPLAY2Cleared 510(K)
- K790694BRITT LENS COMPUTER2Cleared 510(K)
- K790321DATASON DB2Cleared 510(K)
- K790489MICROVIEW2Cleared 510(K)
- K790396ULTRASONIC DIAGNOSTIC SYSTEM2Cleared 510(K)
- K790285IMAGER, PHO/SONIC SERIES 20002Cleared 510(K)
- K790023OCCULAR COMPU-SCAN2Cleared 510(K)
- K790037SONO TRAK T.M.2Cleared 510(K)
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- K781177ULTRASOUND BREAST SCANNING DEVICE2Cleared 510(K)
- K782060MULTIFORMAT FILM CASSETTE TRANSPORT2Cleared 510(K)
- K781709SCANNER, LINEAR2Cleared 510(K)
- K781508WATERPATH SCANNING OPTION2Cleared 510(K)
- K781344OPTION PHO/SONIC B-MODE SCANNER2Cleared 510(K)
- K781079SONOGRAF ULTRASOUND B-SCANNING SYSTEM2Cleared 510(K)
- K781051EMISONIC 42012Cleared 510(K)
- K780578SONOGRAF EDP REAL-TIME ADAPTER2Cleared 510(K)
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- K771930EMISONIC 4500 TM2Cleared 510(K)
- K771934LINEAR ARRAY B-MODE SCANNER2Cleared 510(K)
- K771688ECHO-OCULOMETER2Cleared 510(K)
- K771600ULTRASOUND2Cleared 510(K)
- K771291IMAGE SCANNING TYPE SONOLAY. SAL-10A2Cleared 510(K)
- K771290CONTACT COMPOUNT SONOLAY. SAC-10A2Cleared 510(K)
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- IYYSynchronizer, Electrocardiograph, Nuclear1Product Code
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- 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
ATUSA™ Automated 3D Breast Ultrasound System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K213620
- 510(k) Type
- Traditional
- Applicant
- iSono Health, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/22/2022
- Days to Decision
- 157 days
- Submission Type
- Summary