Anesthesiology
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- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
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- ImmunologyReview Panel
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- 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
- K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System2Cleared 510(K)
- K253448Sonosite MT Ultrasound System2Cleared 510(K)
- K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System2Cleared 510(K)
- K251985LOGIQ E102Cleared 510(K)
- K251963LOGIQ E10s2Cleared 510(K)
- K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System2Cleared 510(K)
- K250026Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000)2Cleared 510(K)
- K251820ViewMateTM Ultrasound System2Cleared 510(K)
- K251368FETOLY2Cleared 510(K)
- K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System (VMM-ICE-02)2Cleared 510(K)
- K251106Sonosite LX and Sonosite PX Ultrasound Systems2Cleared 510(K)
- K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound System (Vaus7); Diagnostic Ultrasound System (Zeus); Diagnostic Ultrasound System (ME7); Diagnostic Ultrasound System (Anesus ME7); Diagnostic Ultrasound System (Anesus ME7T); Diagnostic Ultrasound System (MX7P); Diagnostic Ultrasound System (MX7W); Diagnostic Ultrasound System (MX8); Diagnostic Ultrasound System (MX8T); Diagnostic Ultrasound System (Vaus8); Diagnostic Ultrasound System (ME8)2Cleared 510(K)
- K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System2Cleared 510(K)
- K251322Venue; Venue Go; Venue Fit; Venue Sprint2Cleared 510(K)
- K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System2Cleared 510(K)
- K250999V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System2Cleared 510(K)
- K251830Sonosite LX Ultrasound System2Cleared 510(K)
- K251169Vivid Pioneer2Cleared 510(K)
- K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems2Cleared 510(K)
- K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)2Cleared 510(K)
- K250024TE Air Diagnostic Ultrasound System2Cleared 510(K)
- K250543Voluson™ Performance 16; Voluson™ Performance 182Cleared 510(K)
- K242594DEEPECHO2Cleared 510(K)
- K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System2Cleared 510(K)
- K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R9 Pro); Diagnostic Ultrasound System (Recho R9 Exp); Diagnostic Ultrasound System (Recho R9S); Diagnostic Ultrasound System (Recho R9T); Diagnostic Ultrasound System (Crius R9 CV); Diagnostic Ultrasound System (Anesus R9 CV); Diagnostic Ultrasound System (Recho R9 Super); Diagnostic Ultrasound System (Recho R9 Lumi); Diagnostic Ultrasound System (Recho R CV); Diagnost2Cleared 510(K)
- K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6);2Cleared 510(K)
- K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)2Cleared 510(K)
- K242519Lumify Diagnostic Ultrasound System2Cleared 510(K)
- K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.52Cleared 510(K)
- K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems2Cleared 510(K)
- K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series)2Cleared 510(K)
- K242670Lumify Diagnostic Ultrasound System2Cleared 510(K)
- K250087Vscan Air2Cleared 510(K)
- K250030Flash Ultrasound System 5100 Point of Care2Cleared 510(K)
- K242321Kosmos2Cleared 510(K)
- K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S)2Cleared 510(K)
- K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System2Cleared 510(K)
- K243298Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System2Cleared 510(K)
- K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler Ultrasound Imaging System (Apogee C2); Digital Color Doppler Ultrasound Imaging System (Apogee C3); Digital Color Doppler Ultrasound Imaging System (Apogee C5); Digital Color Doppler Ultrasound Imaging System (Apogee K1); Digital Color Doppler Ultrasound Imaging System (Apogee K2); Digital Color Doppler Ultrasound Imaging System (Apogee K3); Digital Color Doppler Ultrasound Imaging System (Apogee K5); Di2Cleared 510(K)
- K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88)2Cleared 510(K)
- K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25)2Cleared 510(K)
- K243702V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System2Cleared 510(K)
- K243628Vivid T9/Vivid T82Cleared 510(K)
- K243620Vivid iq2Cleared 510(K)
- K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System2Cleared 510(K)
- K243502EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)2Cleared 510(K)
- K241949Digital Color Doppler Ultrasound System (P60 Series)2Cleared 510(K)
- K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 222Cleared 510(K)
- K240676ULTIMUS Series Ultrasound Diagnostic System2Cleared 510(K)
- K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System2Cleared 510(K)
- K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6)2Cleared 510(K)
- K242511V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System2Cleared 510(K)
- K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System2Cleared 510(K)
- K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System2Cleared 510(K)
- K243299ACUSON Redwood Diagnostic Ultrasound System2Cleared 510(K)
- K242800The 5000 Compact Series Ultrasound Systems2Cleared 510(K)
- K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System2Cleared 510(K)
- K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)2Cleared 510(K)
- K241971HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System2Cleared 510(K)
- K240980EPIQ Series Diagnostic Ultrasound System2Cleared 510(K)
- K242005Versana Premier; Versana Premier Lotus; LOGIQ F2Cleared 510(K)
- K242223SuperSonic HepaVu2Cleared 510(K)
- K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)2Cleared 510(K)
- K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/EagusTEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System2Cleared 510(K)
- K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)2Cleared 510(K)
- K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System2Cleared 510(K)
- K241380FETOLY-HEART2Cleared 510(K)
- K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging2Cleared 510(K)
- K241051Vave Wireless Ultrasound System2Cleared 510(K)
- K233826Kosmos2Cleared 510(K)
- K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)2Cleared 510(K)
- K233697SonoMax Series Digital Color Doppler Ultrasound System2Cleared 510(K)
- K240906TE Air Diagnostic Ultrasound System2Cleared 510(K)
- K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System2Cleared 510(K)
- K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System2Cleared 510(K)
- K240684Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound System2Cleared 510(K)
- K233955Clarius OB AI2Cleared 510(K)
- K240516RS85 Diagnostic Ultrasound System2Cleared 510(K)
- K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System2Cleared 510(K)
- K240206Venue Sprint2Cleared 510(K)
- K240111Venue2Cleared 510(K)
- K240053Venue Go2Cleared 510(K)
- K234106Venue Fit2Cleared 510(K)
- K233841HD80 Series Ultrasound Diagnostic System2Cleared 510(K)
- K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)2Cleared 510(K)
- K240406Sonio Detect2Cleared 510(K)
- K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems2Cleared 510(K)
- K240115Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System2Cleared 510(K)
- K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)2Cleared 510(K)
- K233692Voluson Signature 20, Voluson Signature 182Cleared 510(K)
- K233439HD60 Series Ultrasound Diagnostic System2Cleared 510(K)
- K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert); P12 Plus Digital Color Doppler Ultrasound System (P12 Plus); P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus); P9 Plus Ultrasound Diagnostic System (P9 Plus); P3 Plus Ultrasound Diagnostic System (P3 Plus)2Cleared 510(K)
- K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System2Cleared 510(K)
- K233394Gem Flow Now (GEM2770-FN)2Cleared 510(K)
- K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System2Cleared 510(K)
- K232285U-Lite PRO2Cleared 510(K)
- K232808Butterfly iQ3 Ultrasound System2Cleared 510(K)
- K233734Interson USB Ultrasound System2Cleared 510(K)
- K233112HM70 EVO Diagnostic Ultrasound System2Cleared 510(K)
- K231354Pocket Ultrasound System (C10)2Cleared 510(K)
- K232381LOGIQ Totus2Cleared 510(K)
- K233597Sonosite LX Ultrasound System2Cleared 510(K)
- K233545EPIQ Series Diagnostic Ultrasound System2Cleared 510(K)
- K2301796440 MyLabX902Cleared 510(K)
- K232988Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System2Cleared 510(K)
- K231941ARIETTA x102Cleared 510(K)
- K231989LOGIQ E10s, LOGIQ Fortis2Cleared 510(K)
- K231966LOGIQ E102Cleared 510(K)
- K232186LOGIQ e2Cleared 510(K)
- K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System2Cleared 510(K)
- K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 182Cleared 510(K)
- K232500Lumify Diagnostic Ultrasound System2Cleared 510(K)
- K231685TE Air Diagnostic Ultrasound System2Cleared 510(K)
- K231509Aco Apache Ultrasound System2Cleared 510(K)
- K231764Ultrasound System 13002Cleared 510(K)
- K232704Clarius Ultrasound Scanner2Cleared 510(K)
- K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System2Cleared 510(K)
- K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System2Cleared 510(K)
- K232336ES Series V22Cleared 510(K)
- K230066Carnation series Diagnostic Ultrasound System2Cleared 510(K)
- K231301Vscan Air2Cleared 510(K)
- K230365Sonio Detect2Cleared 510(K)
- K230160VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86, VINNO M86E,VINNO G90,VINNO G90E2Cleared 510(K)
- K230346Voluson SWIFT; Voluson SWIFT+2Cleared 510(K)
- K223917VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P2Cleared 510(K)
- K223920VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VINNO X35, VINNO G55E, VINNO G55P, VINNO M55E, VINNO M55P, VINNO E35E, VINNO E35P2Cleared 510(K)
- K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System2Cleared 510(K)
- K231190EPIQ Series Diagnostic Ultrasound System2Cleared 510(K)
- K223771Lumify Diagnostic Ultrasound System2Cleared 510(K)
- K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System2Cleared 510(K)
- K223564X-CUBE 50, X-CUBE 602Cleared 510(K)
- K223830Ultrasound System 23002Cleared 510(K)
- K223570SonoAir Series Digital Color Doppler Ultrasound System2Cleared 510(K)
- K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.02Cleared 510(K)
- K223832Vivid S60N, Vivid S70N2Cleared 510(K)
- K223407Versana Essential2Cleared 510(K)
- K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System2Cleared 510(K)
- K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System2Cleared 510(K)
- K222596S90 Exp Series Digital Color Doppler Ultrasound System2Cleared 510(K)
- K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound System2Cleared 510(K)
- K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System2Cleared 510(K)
- K221911VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP2Cleared 510(K)
- K222441Ultrasound System 23002Cleared 510(K)
- K220983ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System2Cleared 510(K)
- K222754ViewMate Multi Ultrasound System2Cleared 510(K)
- K222198Exo Iris (El2001)2Cleared 510(K)
- K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH402Cleared 510(K)
- K222365Leltek Ultrasound Imaging System (Model: LU700 Series)2Cleared 510(K)
- K221093X-CUBE 70, X-CUBE 902Cleared 510(K)
- K220857X-CUBE 50, X-CUBE 602Cleared 510(K)
- K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)2Cleared 510(K)
- K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)2Cleared 510(K)
- K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System2Cleared 510(K)
- K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System2Cleared 510(K)
- K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W)2Cleared 510(K)
- K221089P12 Elite Series Digital Color Doppler Ultrasound System2Cleared 510(K)
- K221140P20 Elite Series Digital Color Doppler Ultrasound System2Cleared 510(K)
- K221568KOLO Evolution XHD Series Ultrasound Diagnostic System2Cleared 510(K)
- K221599HS40 Diagnostic Ultrasound System2Cleared 510(K)
- K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System2Cleared 510(K)
- K220882Vivid E80, Vivid E90, Vivid E952Cleared 510(K)
- K221148Vivid iq2Cleared 510(K)
- K221147Vivid T8, Vivid T92Cleared 510(K)
- K220619Vivid S60N, Vivid S70N2Cleared 510(K)
- K213009Transcranial Doppler Ultrasound System2Cleared 510(K)
- K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System2Cleared 510(K)
- K220848Venue Fit2Cleared 510(K)
- K220851Venue2Cleared 510(K)
- K220993Ultrasound System SONIMAGE MX12Cleared 510(K)
- K220800Venue Go2Cleared 510(K)
- K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System2Cleared 510(K)
- K221500ACUSON Sequoia Diagnostic Ultrasound System2Cleared 510(K)
- K213862HD60 Series Ultrasound Diagnostic System2Cleared 510(K)
- K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 182Cleared 510(K)
- K211665SONON Ultrasound Imaging System, Model: SONON300C2Cleared 510(K)
- K220446Versana Balance2Cleared 510(K)
- K220269HM70 EVO Diagnostic Ultrasound System2Cleared 510(K)
- K220295ARIETTA 502Cleared 510(K)
- K212400SONON Ultrasound Imaging System, Model: SONON 500L2Cleared 510(K)
- K220490ImaCor Zura Handheld ZHH-0102Cleared 510(K)
- K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System2Cleared 510(K)
- K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System2Cleared 510(K)
- K214039LOGIQ P10, LOGIQ P9, LOGIQ P82Cleared 510(K)
- K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.52Cleared 510(K)
- K220051TE Air Diagnostic Ultrasound System2Cleared 510(K)
- K213279NovaGuide 2 Intelligent Ultrasound2Cleared 510(K)
- K211746Pocket Ultrasound System2Cleared 510(K)
- K213689Voluson P6, Voluson P82Cleared 510(K)
- K213487ACUSON P500 Ultrasound System2Cleared 510(K)
- K211248ArtUs2Cleared 510(K)
- K213523X-CUBE i8, X-CUBE i92Cleared 510(K)
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- K163691HS70A Diagnostic Ultrasound System2Cleared 510(K)
- K163596LOGIQ P9 and LOGIQ P72Cleared 510(K)
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- K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems2Cleared 510(K)
- K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System2Cleared 510(K)
- K163396ACUSON P500 Ultrasound System2Cleared 510(K)
- K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System2Cleared 510(K)
- K162902ARIETTA Prologue Diagnostic Ultrasound system and Transducers2Cleared 510(K)
- K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System2Cleared 510(K)
- K163138Clarius Ultrasound System2Cleared 510(K)
- K163077LOGIQ E9, LOGIQ E9 XDClear 2.02Cleared 510(K)
- K162583ALOKA LISENDO 8802Cleared 510(K)
- K163020Xperius Ultrasound System2Cleared 510(K)
- K161999Aixplorer2Cleared 510(K)
- K162155Xario 200 Diagnostic Ultrasound System V5.02Cleared 510(K)
- K160442Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers2Cleared 510(K)
- K162065Ultrasound System SONIMAGE HS12Cleared 510(K)
- K160559NOBLUS™ Ultrasound Diagnostic System2Cleared 510(K)
- K161960bk23002Cleared 510(K)
- K162290MyLabSix CrystaLine2Cleared 510(K)
- K162549Lumify Ultrasound System2Cleared 510(K)
- K162269Voluson E6, Voluson E8, Voluson E102Cleared 510(K)
- K153539RS80A Diagnostic Ultrasound System2Cleared 510(K)
- K162187Xario 100 Diagnostic Ultrasound System, V5.02Cleared 510(K)
- K162417Acuson Freestyle Ultrasound System2Cleared 510(K)
- K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.02Cleared 510(K)
- K161439E-CUBE 112Cleared 510(K)
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- K162288SonoSite iViz Ultrasound System2Cleared 510(K)
- K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System2Cleared 510(K)
- K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System2Cleared 510(K)
- K162221ACUSON SC2000 Diagnostic Ultrasound System2Cleared 510(K)
- K161168MyLabSix Ultrasound System2Cleared 510(K)
- K161588Vscan Extend2Cleared 510(K)
- K162094RS80A Diagnostic Ultrasound System2Cleared 510(K)
- K162045SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System2Cleared 510(K)
- K161706Vivid iq2Cleared 510(K)
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- K161787ACUSON NX2 Diagnostic Ultrasound Systems2Cleared 510(K)
- K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System2Cleared 510(K)
- K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System2Cleared 510(K)
- K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System2Cleared 510(K)
- K161119SonoSite iViz Ultrasound System2Cleared 510(K)
- K161047LOGIQ P9 and LOGIQ P72Cleared 510(K)
- K1532776200 Ultrasound System and 6250 Ultrasound System2Cleared 510(K)
- K160357TRINITY2Cleared 510(K)
- K160162Voluson P6, Voluson P82Cleared 510(K)
- K160674Fujifilm Sonosite Vevo MD Imaging System2Cleared 510(K)
- K160343SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner2Cleared 510(K)
- K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System2Cleared 510(K)
- K160734SonoSite SII Ultrasound System2Cleared 510(K)
- K160790Acclarix LX8 Diagnostic Ultrasound System2Cleared 510(K)
- K160283S45 Digital Color Doppler Ultrasound System2Cleared 510(K)
- K160258X5 Digital Color Doppler Ultrasound System2Cleared 510(K)
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- K153424E-CUBE i72Cleared 510(K)
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- K153529WS80A Diagnostic Ultrasound System2Cleared 510(K)
- K153421HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS2Cleared 510(K)
- K153626SonoSite Edge II Ultrasound System2Cleared 510(K)
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- K153085Q Series Diagnostic Ultrasound System2Cleared 510(K)
- K153480ClearVue850 Diagnostic Ultrasound System2Cleared 510(K)
- K152467Touch Ultrasound2Cleared 510(K)
- K152758Venue 502Cleared 510(K)
- K152983FUJIFILM SonoSite iViz Ultrasound System2Cleared 510(K)
- K152567Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System2Cleared 510(K)
- K152962HS70A Diagnostic Ultrasound System2Cleared 510(K)
- K152899Philips Lumify Diagnostic Ultrasound System2Cleared 510(K)
- K152543M9/M9CV/M9T Diagnostic Ultrasound System2Cleared 510(K)
- K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System2Cleared 510(K)
- K152577ULTRASOUND SYSTEM SONIMAGE HS 12Cleared 510(K)
- K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System2Cleared 510(K)
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- K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems2Cleared 510(K)
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- K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System2Cleared 510(K)
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- K152396S12 Digital Color Doppler Ultrasound System2Cleared 510(K)
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- K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System2Cleared 510(K)
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- K150773E-CUBE 15 Diagnostic Ultrasound System2Cleared 510(K)
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- K150002iNSIGHT Color Doppler Ultrasound System2Cleared 510(K)
- K143476Digi-One2Cleared 510(K)
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- K150628VentriPoint Medical System2Cleared 510(K)
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- K150478A35 Diagnostic Ultrasound System2Cleared 510(K)
- K143601U-Lite2Cleared 510(K)
- K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System2Cleared 510(K)
- K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System2Cleared 510(K)
- K150148Terason uSmart3300 Ultrasound System2Cleared 510(K)
- K142511U50 Diagnostic Ultrasound System2Cleared 510(K)
- K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems2Cleared 510(K)
- K150050ACUSON P500 Diagnostic Ultrasound System2Cleared 510(K)
- K143452LOGIQ P9, LOGIQ P72Cleared 510(K)
- K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System2Cleared 510(K)
- K142815S22 Digital Color Doppler Ultrasound System2Cleared 510(K)
- K143298Ultrasound Scanner System bk23002Cleared 510(K)
- K142368NOBLUS DIAGNOSTIC ULTRASOUND SCANNER2Cleared 510(K)
- K142710S9 Portable Digital Color Doppler Ultrasound System2Cleared 510(K)
- K143472TE7 Diagnostic Ultrasound System2Cleared 510(K)
- K142474S12 Digital Color Doppler Ultrasound System2Cleared 510(K)
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- K143089WS80A Diagnostic Ultrasound System2Cleared 510(K)
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- K143027Xario 200, V3.02Cleared 510(K)
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- K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems2Cleared 510(K)
- K142628Acuson SC2000 Diagnostic Ultrasound System2Cleared 510(K)
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- K142466UGEO PT60A Diagnostic Ultrasound System2Cleared 510(K)
- K142077MYLABGAMMA2Cleared 510(K)
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- K141641ZONARE ZS3 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K141639VOLUSON S6, VOLUSON S82Cleared 510(K)
- K141486MYLABSIX ULTRASOUND SYSTEM2Cleared 510(K)
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- K141010M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K140959ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS2Cleared 510(K)
- K140834TERASON USMART3400 ULTRASOUND SYSTEM2Cleared 510(K)
- K140677MYLABSSOGNO2Cleared 510(K)
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- K140639PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
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- K140153VENTRIPOINT MEDICAL SYSTEM2Cleared 510(K)
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- K111864E-CUBE 92Cleared 510(K)
- K111674ACUSON2Cleared 510(K)
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- K803246ULTRASONIC STETHOSCOPE2Cleared 510(K)
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- K801655AUTO SECTOR SCANNER2Cleared 510(K)
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- 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
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- 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
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- OIORadiographic Contrast Tray2Product Code
- OIPRadiology-Diagnostic Kit2Product Code
- OMJChest X-Ray Computer Aided Detection2Product Code
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- QASRadiological Computer-Assisted Triage And Notification Software2Product Code
- QBSRadiological Computer Assisted Detection/Diagnosis Software For Fracture2Product Code
- QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer2Product 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
- QJUImage Acquisition And/Or Optimization Guided By Artificial Intelligence2Product 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
- SFVX-Ray, Computed Tomography, Cone-Beam2Product 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
SONON Ultrasound Imaging System, Model: SONON300C
- Page Type
- Cleared 510(K)
- 510(k) Number
- K211665
- 510(k) Type
- Special
- Applicant
- HEALCERION CO., LTD.
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/16/2022
- Days to Decision
- 349 days
- Submission Type
- Summary