Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- EAGCephalometer2Product Code
- EAHCone, Radiographic, Lead-Lined1Product Code
- EAPUnit, X-Ray, Intraoral2Product Code
- EHBCollimator, X-Ray1Product Code
- EHDUnit, X-Ray, Extraoral With Timer2Product Code
- MUHSystem, X-Ray, Extraoral Source, Digital2Product Code
- EAMScreen, Intensifying, Radiographic1Product Code
- EGTController, Temperature, Radiographic2Product Code
- EGWDryer, Film, Radiographic2Product Code
- EGYProcessor, Radiographic-Film, Automatic, Dental2Product Code
- HBKChair, Pneumoencephalographic2Product Code
- ITXTransducer, Ultrasonic, Diagnostic2Product Code
- ITYAssembly, Tube Housing, X-Ray, Diagnostic1Product Code
- IWNCassette, Measurement, Ardran-Crooks1Product Code
- IWYHolder, Head, Radiographic1Product Code
- IWZFilm, Radiographic1Product Code
- IXACassette, Radiographic Film2Product Code
- IXCIlluminator, Radiographic-Film1Product Code
- IXDSource, Calibration, Sealed, Nuclear1Product Code
- IXFTest-Pattern, Radiographic1Product Code
- IXGPhantom, Anthropomorphic, Radiographic1Product Code
- IXHCamera, Focal Spot, Radiographic1Product Code
- IXJGrid, Radiographic1Product Code
- IXKSystem, Imaging, X-Ray, Electrostatic2Product Code
- IXLDevice, Spot-Film2Product Code
- IXOSynchronizer, Ecg / Respirator, Radiographic1Product Code
- IXQTable, Radiographic, Stationary Top2Product Code
- IXRTable, Radiographic, Tilting2Product Code
- IXWProcessor, Radiographic-Film, Automatic2Product Code
- IXXProcessor, Cine Film2Product Code
- IXYHolder, Radiographic Cassette, Wall-Mounted1Product Code
- IYBTube Mount, X-Ray, Diagnostic1Product Code
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic2Product Code
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic2Product Code
- IYPPhantom, Anthropomorphic, Nuclear1Product Code
- IYQPhantom, Flood Source, Nuclear1Product Code
- IYTSystem, Rebreathing, Radionuclide2Product Code
- IYWScanner, Rectilinear, Nuclear1Product Code
- IYXCamera, Scintillation (Gamma)1Product Code
- IYYSynchronizer, Electrocardiograph, Nuclear1Product Code
- IYZBed, Scanning, Nuclear1Product Code
- IZCCamera, Positron1Product Code
- IZDProbe, Uptake, Nuclear1Product Code
- IZFSystem, X-Ray, Tomographic2Product Code
- IZGSystem, X-Ray, Photofluorographic2Product Code
- IZHSystem, X-Ray, Mammographic2Product Code
- IZISystem, X-Ray, Angiographic2Product Code
- IZJCamera, X-Ray, Fluorographic, Cine Or Spot2Product Code
- IZLSystem, X-Ray, Mobile2Product Code
- 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
- K24149921.3” 5MP Color LCD Display UMD5-21B012Cleared 510(K)
- K23333621.3 3MP Color LCD Display UMD3-21B01 (MD3-21B01)2Cleared 510(K)
- K240310LCD Monitors C310S, G310S, C316S, G316S, C616W2Cleared 510(K)
- K240130Medical Monitor (21HQ613D)2Cleared 510(K)
- K2338975MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)2Cleared 510(K)
- K233465RadiForce MX317W2Cleared 510(K)
- K233693Nio Color 8MP (MDNC-8132)2Cleared 510(K)
- K23298524HR513C2Cleared 510(K)
- K23102612MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models)2Cleared 510(K)
- K23212721HQ513D, 32HL512D, 31HN713D, 32HQ713D2Cleared 510(K)
- K230728JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor2Cleared 510(K)
- K231170C350/C350G LCD Monitor; M550/M550G LCD Monitor2Cleared 510(K)
- K230723C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor2Cleared 510(K)
- K230684RadiForce MX2172Cleared 510(K)
- K222719CX50N2Cleared 510(K)
- K222716MX50N2Cleared 510(K)
- K230643CP620G LCD monitor, CP620 LCD monitor2Cleared 510(K)
- K23084532HL512D, 31HN713D, 32HQ713D2Cleared 510(K)
- K223768RadiForce RX2702Cleared 510(K)
- K230520Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)2Cleared 510(K)
- K22342332HQ713D2Cleared 510(K)
- K22378921HQ513D2Cleared 510(K)
- K2228648MP Color LCD Monitor CL-R8132Cleared 510(K)
- K222208Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D2Cleared 510(K)
- K222132Hisense LCD monitor HMD2G21S, HMD3G21S2Cleared 510(K)
- K222717CL24N2Cleared 510(K)
- K222722CW60N2Cleared 510(K)
- K222121C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor2Cleared 510(K)
- K221567LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)2Cleared 510(K)
- K22106121HQ613D2Cleared 510(K)
- K221136RadiForce MX243W2Cleared 510(K)
- K212231C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor2Cleared 510(K)
- K2129856MP Color LCD Monitor CL-S6002Cleared 510(K)
- K21229521HQ513D2Cleared 510(K)
- K211491RadiForce RX3702Cleared 510(K)
- K20373312MP Color Digital Mammography LCD Monitor CL-S12002Cleared 510(K)
- K2103452MP Monochrome LCD Monitor MS-S2002Cleared 510(K)
- K210493CX30N (CX30PQX)2Cleared 510(K)
- K210491CW120N2Cleared 510(K)
- K203106Nio Fusion 12MP (MDNC-12130)2Cleared 510(K)
- K2023744MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+2Cleared 510(K)
- K20177731HN713D2Cleared 510(K)
- K2012113MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+2Cleared 510(K)
- K200742JUSHA-CP610 LCD Monitor2Cleared 510(K)
- K2015992MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+2Cleared 510(K)
- K200889iMac 27 & PL 4.02Cleared 510(K)
- K2008645MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+2Cleared 510(K)
- K200485RadiForce RX1270, RadiForce RX1270-AR2Cleared 510(K)
- K191705OptikView GUP2103CMI2Cleared 510(K)
- K19292532HL512D2Cleared 510(K)
- K2001613MP Monochrome Digital Mammography LCD Monitor MS-S3002Cleared 510(K)
- K19186421HK512D2Cleared 510(K)
- K191845Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)2Cleared 510(K)
- K1911375MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S5002Cleared 510(K)
- K190848JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor2Cleared 510(K)
- K183496JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor2Cleared 510(K)
- K183494R190/R191 LCD Monitor2Cleared 510(K)
- K183492JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor2Cleared 510(K)
- K190153RadiForce MX2162Cleared 510(K)
- K183498JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor2Cleared 510(K)
- K183499JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor2Cleared 510(K)
- K183497JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor2Cleared 510(K)
- K1822916MP Color LCD Monitor (C61W+)2Cleared 510(K)
- K182591RadiForce RX360, RX360-AR2Cleared 510(K)
- K1825392MP Color LCD Monitor CL-R2112Cleared 510(K)
- K181609RadiForce GX560, GX560-AR2Cleared 510(K)
- K180961RadiForce MX1942Cleared 510(K)
- K1734342MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S3002Cleared 510(K)
- K172738RadiForce RX560, RX560-AR2Cleared 510(K)
- K1728152MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)2Cleared 510(K)
- K171812Nio Color 2MP (MDNC-2123)2Cleared 510(K)
- K171229DELL UP3017 with QUBYX PerfectLum bundle2Cleared 510(K)
- K170944LCD Monitor (MD310C, MD310G, MD210G)2Cleared 510(K)
- K170949RadiForce MX315W2Cleared 510(K)
- K170837Nio Color 3MP (MDNC-3421)2Cleared 510(K)
- K170781MX50N(MX50YQS)2Cleared 510(K)
- K170783CX50N(CX50YQS)2Cleared 510(K)
- K170476Nio Color 5.8MP (MDNC-6121)2Cleared 510(K)
- K1633356MP Color LCD Monitor, RadiForce RX660, RX660-AR2Cleared 510(K)
- K1625278MP Color LCD Monitor (C81W+)2Cleared 510(K)
- K1624975MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR2Cleared 510(K)
- K1618952MP Color LCD Monitor CCL214 (CL21214)2Cleared 510(K)
- K162196Dell UP3216Q with QUBYX PerfectLum bundle2Cleared 510(K)
- K161229Mammo Tomosynthesis (MDMG-5221)2Cleared 510(K)
- K161057Diagnostic Imaging Color LCD Monitor2Cleared 510(K)
- K160354MX50T(MX50TQS)2Cleared 510(K)
- K160353MX50N(MX50YQS)2Cleared 510(K)
- K160346MX30N(MX30TQS)2Cleared 510(K)
- K160348CX30N (CX30PQX)2Cleared 510(K)
- K160351CX50N, CX50YQS2Cleared 510(K)
- K160355CX20N(CX20PUX)2Cleared 510(K)
- K160347Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G212Cleared 510(K)
- K160328DIVA ZSP2105CMI with QUBYX PerfectLum bundle2Cleared 510(K)
- K1603265MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)2Cleared 510(K)
- K1602472MP Color LCD Monitor, RadiForce RX250 and RX250-AR2Cleared 510(K)
- K1533543MP Color LCD Monitor, RadiForce RX3502Cleared 510(K)
- K1527138MP Color LCD Monitor, RadiForce RX850, RX850-AR2Cleared 510(K)
- K152847DIVA ZSP5812CMI with QUBYX PerfectLum bundle2Cleared 510(K)
- K152030Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)2Cleared 510(K)
- K151972JUSHA-C43 LCD Monitor2Cleared 510(K)
- K151861JUSHA-C23C LCD Monitor2Cleared 510(K)
- K1518835MP Monochrome LCD Monitor, RadiForce GX5402Cleared 510(K)
- K151505Coronis Uniti2Cleared 510(K)
- K151238JUSHA-M23C LCD Monitor2Cleared 510(K)
- K15113421.3 inch (54cm) Color LCD Monitor CCL210 (CL21210)2Cleared 510(K)
- K15100721.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550)2Cleared 510(K)
- K150842JUSHA-M53 Medical Display2Cleared 510(K)
- K150746JUSHA-M52C Medical Display2Cleared 510(K)
- K150821MDNG-3220 (Nio 3MP LED)2Cleared 510(K)
- K1501062MP Color LCD Monitor, RadiForce RS2402Cleared 510(K)
- K150145MD322C8 31.5 Diagnostic Imaging LCD Monitor2Cleared 510(K)
- K143718Mammography Color Display DP-M30102Cleared 510(K)
- K142951MD210C3 21.3 Diagnostic Imaging LCD Monitor2Cleared 510(K)
- K1432612.3MP Color LCD Monitor, RadiForce MX242W2Cleared 510(K)
- K1430983MP Color LCD monitor, RadiForce RS3402Cleared 510(K)
- K143157Coronis Fusion 4MP LED2Cleared 510(K)
- K14307620.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205)2Cleared 510(K)
- K14254024.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244)2Cleared 510(K)
- K14253621.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220)2Cleared 510(K)
- K141891MEDICAL LCD MONITOR2Cleared 510(K)
- K141690JUSHA-M33C LCD MONITOR2Cleared 510(K)
- K141679JUSHA-C61 LCD MONITOR2Cleared 510(K)
- K141684JUSHA-C33C LCD MONITOR2Cleared 510(K)
- K131601DELL U3014 WITH QUBYX PERFECTLUM BUNDLE2Cleared 510(K)
- K141428MDMC-121332Cleared 510(K)
- K1407028MP COLOR LCD MONITOR, RADIFORCE RX8502Cleared 510(K)
- 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
Mammo Tomosynthesis (MDMG-5221)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K161229
- 510(k) Type
- Special
- Applicant
- BARCO N.V.
- Country
- Belgium
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/18/2016
- Days to Decision
- 16 days
- Submission Type
- Summary