Anesthesiology
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- 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
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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
- 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)
- 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)
- 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)
- K221147Vivid T8, Vivid T92Cleared 510(K)
- K221148Vivid iq2Cleared 510(K)
- K220619Vivid S60N, Vivid S70N2Cleared 510(K)
- K213009Transcranial Doppler Ultrasound System2Cleared 510(K)
- K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System2Cleared 510(K)
- K220851Venue2Cleared 510(K)
- K220848Venue Fit2Cleared 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)
- K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.52Cleared 510(K)
- K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert2Cleared 510(K)
- K213102ES1 System2Cleared 510(K)
- K213763Sonosite PX Ultrasound System2Cleared 510(K)
- K211886Clivia series Diagnostic Ultrasound System2Cleared 510(K)
- K212265TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System2Cleared 510(K)
- K213436Clarius Ultrasound Scanner2Cleared 510(K)
- K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System2Cleared 510(K)
- K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)2Cleared 510(K)
- K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System2Cleared 510(K)
- K2120216430 MyLabX75, 6430 MyLab XPro752Cleared 510(K)
- K211488LOGIQ E102Cleared 510(K)
- K210438Versana Premier2Cleared 510(K)
- K211824HERA W9, HERA W10 Diagnostic Ultrasound System2Cleared 510(K)
- K211945V8 Diagnostic Ultrasound System2Cleared 510(K)
- K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System2Cleared 510(K)
- K211524LOGIQ E10s, LOGIQ Fortis2Cleared 510(K)
- K211527Exo Iris2Cleared 510(K)
- K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System2Cleared 510(K)
- K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System2Cleared 510(K)
- K211299X-CUBE 702Cleared 510(K)
- K211300X-CUBE 902Cleared 510(K)
- K212100Kosmos2Cleared 510(K)
- K210154Labat series Diagnostic Ultrasound System2Cleared 510(K)
- K211859ACUSON Sequoia Diagnostic Ultrasound System2Cleared 510(K)
- K210713HM70 EVO Diagnostic Ultrasound System2Cleared 510(K)
- K211337DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System2Cleared 510(K)
- K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH402Cleared 510(K)
- K211232Apache Ultrasound System2Cleared 510(K)
- K203657Vu-Path Ultrasound System2Cleared 510(K)
- K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System2Cleared 510(K)
- K210699Resona 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 Diagnostic Ultrasound System2Cleared 510(K)
- K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System2Cleared 510(K)
- K211216Vivid S60N / Vivid S70N2Cleared 510(K)
- K210426HS40 Diagnostic Ultrasound System2Cleared 510(K)
- K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System2Cleared 510(K)
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- K152567Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System2Cleared 510(K)
- K152962HS70A Diagnostic Ultrasound System2Cleared 510(K)
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- K152543M9/M9CV/M9T Diagnostic Ultrasound System2Cleared 510(K)
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- K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System2Cleared 510(K)
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- K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System2Cleared 510(K)
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- K141010M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
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- K140834TERASON USMART3400 ULTRASOUND SYSTEM2Cleared 510(K)
- K140677MYLABSSOGNO2Cleared 510(K)
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- K140639PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
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- K936067ATLAS 1.0 DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K945773SIEMENS SONOLINE VERSA2Cleared 510(K)
- K951695OPERAND* ULTRASOUND TRANSMISSION GEL2Cleared 510(K)
- K944048ULTRASOUND 77030 IMAGING SYSTEM2Cleared 510(K)
- K930458MULTI-DOP L2Cleared 510(K)
- K943863NEEDLE GUIDE2Cleared 510(K)
- K935923PHILIPS ULTRASOUND P800 IMAGING SYSTEM2Cleared 510(K)
- K941652ALOKA SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM MODIFICATION2Cleared 510(K)
- K934915ACUSON MODEL 20012Cleared 510(K)
- K933743SSA-380A2Cleared 510(K)
- K935009PEGASUS2Cleared 510(K)
- K933916AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER2Cleared 510(K)
- K934041HEWLETT PACKARD CONOS ULTRASOUND IMAGING SYSTEM MODIFICATION2Cleared 510(K)
- K933202VENUS DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K915403DIAGNOSTIC ULTRASOUND SYSTEM2Cleared 510(K)
- K940285ACUSON PICTURE ARCHIVING & COMMUNICATION SYSTEM MODIFICATION2Cleared 510(K)
- K931293SSH-140A FETAL DOPPLER SYSTEM2Cleared 510(K)
- K926351COLORMARK(TM) VISUALIZATION SYSTEM2Cleared 510(K)
- K924204NEW ULTRASOUND IMAGING SYSTEM & TRANSDUCERS2Cleared 510(K)
- K914862CEREBROVASCULAR DIAGNOSTIC SYSTEM; CDS2Cleared 510(K)
- K912819SC1150 CW/PD2Cleared 510(K)
- K905198DIAGNOSTIC ULTRASOUND SYSTEM TYPE 35352Cleared 510(K)
- K904017SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICES2Cleared 510(K)
- K904359ESI-3000 ULTRASOUND SYSTEM2Cleared 510(K)
- K902691DOPPLER OPTION FOR PLATINUM2Cleared 510(K)
- K901329CEPHALIC DOPPLER W/ULTRAMARK 9 ULTRASOUND SYSTEM2Cleared 510(K)
- K893861TMI LW-100 PULSED DOPPLER SYSTEM2Cleared 510(K)
- K894163PHASE 2 TRANSCRANIAL PROBE2Cleared 510(K)
- K8940545.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER2Cleared 510(K)
- K893833AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM W/DOPPLER2Cleared 510(K)
- K893042CATHSCANNER(R) INTRAVASCULAR ULTRA IMAGING SYSTEM2Cleared 510(K)
- K885211RF-100 MONITOR, RF-P-2.5, RF-P-5, RF-P-7.5 PROBES2Cleared 510(K)
- K891238SIEMENS TRANSESOPHAGEAL ECHO TEE TRANSDUCER2Cleared 510(K)
- K890055ACUSON S228 TRANSDUCER FOR TRANSCRANIAL DOPPLER2Cleared 510(K)
- K890998QAD ANGIODYNOGRAPH ULTRASOUND: COLOR DOPPLER EVAL.2Cleared 510(K)
- K885155MENTOR MDS2Cleared 510(K)
- K882585CAVROLAB2Cleared 510(K)
- K882755MODEL 500V VASCULAR SPECTRUM ANALYZER2Cleared 510(K)
- K882737ACUSON I7505 TRANSDUCER, ULTRASOUND TRANSDUCER2Cleared 510(K)
- K882015TRANSCRAN(TM) TRANSCRANIAL PULSED DOPPLER SYSTEM2Cleared 510(K)
- K8728175 MHZ DOPPLER OUTRIGGER2Cleared 510(K)
- K872292TRANSPECT TRANSCRANIAL DOPPLER2Cleared 510(K)
- K863577DOPPLER UNIT, SDS-100A2Cleared 510(K)
- K850071TECA MF-20 MICROVASCULAR DOPPLER2Cleared 510(K)
- K844293AUTO DII MULTI FREQUENCY2Cleared 510(K)
- K842407PULSED DOPPLER OPTION, CONTINU-WAVE2Cleared 510(K)
- K842055PICKER ARTIS ULTRASOUND IMAGING SYS2Cleared 510(K)
- K840140DOPPLER IMAGING OPTION2Cleared 510(K)
- K840953ACCESS SCANHEADSS2Cleared 510(K)
- K840402AUDIO BANDWIDTH ANALYZER2Cleared 510(K)
- K813544IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS.2Cleared 510(K)
- K812606SECTORTAC2Cleared 510(K)
- K810133ULTRAPROBE2Cleared 510(K)
- K810118LS1000 ELECTRONIC FOCUS2Cleared 510(K)
- K803246ULTRASONIC STETHOSCOPE2Cleared 510(K)
- K802979DIASONICS SMALL PARTS SCANNER2Cleared 510(K)
- K802254GENERAL ULTRASOUND EXAM. TABLE2Cleared 510(K)
- K801972TRUE SPECTRUM ANALYSIS/MARK IV DUPLEX2Cleared 510(K)
- K801655AUTO SECTOR SCANNER2Cleared 510(K)
- K801656EDP 1200 SECTOR SCANNER OPTION2Cleared 510(K)
- K801512DOPPLER ULTRASONIC STETHOSCOPE2Cleared 510(K)
- K781642RA-I2Cleared 510(K)
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic2Product Code
- IYPPhantom, Anthropomorphic, Nuclear1Product Code
- IYQPhantom, Flood Source, Nuclear1Product Code
- IYTSystem, Rebreathing, Radionuclide2Product Code
- IYWScanner, Rectilinear, Nuclear1Product Code
- IYXCamera, Scintillation (Gamma)1Product Code
- IYYSynchronizer, Electrocardiograph, Nuclear1Product Code
- IYZBed, Scanning, Nuclear1Product Code
- IZCCamera, Positron1Product Code
- IZDProbe, Uptake, Nuclear1Product Code
- IZFSystem, X-Ray, Tomographic2Product Code
- IZGSystem, X-Ray, Photofluorographic2Product Code
- IZHSystem, X-Ray, Mammographic2Product Code
- IZISystem, X-Ray, Angiographic2Product Code
- IZJCamera, X-Ray, Fluorographic, Cine Or Spot2Product Code
- IZLSystem, X-Ray, Mobile2Product Code
- IZOGenerator, High-Voltage, X-Ray, Diagnostic1Product Code
- IZPProgrammer, Changer, Film/Cassette, Radiographic2Product Code
- IZSAperture, Radiographic2Product Code
- IZTCone, Radiographic2Product Code
- IZWCollimator, Automatic, Radiographic2Product Code
- IZXCollimator, Manual, Radiographic2Product Code
- IZZTable, Radiographic, Non-Tilting, Powered2Product Code
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified2Product Code
- JABSystem, X-Ray, Fluoroscopic, Non-Image-Intensified2Product Code
- JACSystem, X-Ray, Film Marking, Radiographic1Product Code
- JAFMonitor, Ultrasonic, Nonfetal2Product Code
- JAGIlluminator, Radiographic-Film, Explosion-Proof1Product Code
- JAKSystem, X-Ray, Tomography, Computed2Product Code
- JAMScanner, Whole Body, Nuclear1Product Code
- JANCounter, Whole Body, Nuclear1Product Code
- JAOScanner, Fluorescent2Product Code
- JARPhantom, Test-Pattern, Radionuclide1Product Code
- JWMSystem, Tomographic, Nuclear2Product Code
- KGIDensitometer, Bone2Product Code
- KPRSystem, X-Ray, Stationary2Product Code
- KPSSystem, Tomography, Computed, Emission2Product Code
- KPTCalibrator, Dose, Radionuclide2Product Code
- KPWDevice, Beam Limiting, X-Ray, Diagnostic2Product Code
- KPXChanger, Radiographic Film/Cassette2Product Code
- KXHCradle, Patient, Radiologic1Product Code
- KXJTable, Radiologic2Product Code
- LEKTransilluminator (Diaphanoscope)3Product Code
- LHOInstrument, Quality-Assurance, Radiologic1Product Code
- LLZSystem, Image Processing, Radiological2Product Code
- LMADigitizer, Image, Radiological2Product Code
- LMBDevice, Digital Image Storage, Radiological1Product Code
- LMCCamera, Multi Format, Radiological2Product Code
- LMDSystem, Digital Image Communications, Radiological1Product Code
- LNHSystem, Nuclear Magnetic Resonance Imaging2Product Code
- LNISystem, Nuclear Magnetic Resonance Spectroscopic2Product Code
- LQAMedia, Reusable Image1Product Code
- MOSCoil, Magnetic Resonance, Specialty2Product Code
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)2Product Code
- MUABone Sonometer2Product Code
- MUEFull Field Digital, System, X-Ray, Mammographic2Product Code
- MUIMedia, Coupling, Ultrasound2Product Code
- MWPCabinet, X-Ray System2Product Code
- MYNAnalyzer, Medical Image2Product Code
- NCSSystem, Imaging, Holography, Acoustic2Product Code
- NWEColon Computed Tomography System, Computer Aided Detection2Product Code
- OASX-Ray, Tomography, Computed, Dental2Product Code
- OEBLung Computed Tomography System, Computer-Aided Detection2Product Code
- OIIArthrogram Tray2Product Code
- OIJBiopsy Needle Guide Kit2Product Code
- OIKRadiology Dental Tray2Product Code
- OILDiscography Kit2Product Code
- OIMMri Disposable Kit2Product Code
- OIORadiographic Contrast Tray2Product Code
- OIPRadiology-Diagnostic Kit2Product Code
- OMJChest X-Ray Computer Aided Detection2Product Code
- OQQDiagnostic Ultrasonic Transducer, Robotic2Product Code
- OUOTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance2Product Code
- OWBInterventional Fluoroscopic X-Ray System2Product Code
- OXOImage-Intensified Fluoroscopic X-Ray System, Mobile2Product Code
- PGYDisplay, Diagnostic Radiology2Product Code
- POKComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer2Product Code
- QASRadiological Computer-Assisted Triage And Notification Software2Product Code
- QFMRadiological Computer-Assisted Prioritization Software For Lesions2Product Code
- QHAX-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device2Product Code
- QHXFluoroscopic X-Ray Image Intensifier1Product Code
- QHYSolid State Fluoroscopic X-Ray Imager2Product Code
- QIHAutomated Radiological Image Processing Software2Product Code
- QKBRadiological Image Processing Software For Radiation Therapy2Product Code
- RCCC-Arm Fluoroscopic X-Ray System2Product Code
- QTZRadiological Image Processing Software For Ablation Therapy Planning And Evaluation2Product Code
- QXLCabinet, Emission Computed Tomography System2Product Code
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
KOLO Evolution XHD Series Ultrasound Diagnostic System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K221568
- 510(k) Type
- Traditional
- Applicant
- Kolo Medical (Suzhou) Co., Ltd
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/12/2022
- Days to Decision
- 104 days
- Submission Type
- Summary