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Radiology

14,649 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
PTW DAVID IMRT QC VERIFICATION SYSTEM (K062817)Ptw-New York Corp.2006-11-22
XPLORER 1500 DIGITAL RADIOGRAPHIC SYSTEM WITH STAND (K063246)Imaging Dynamics Company , Ltd.2006-11-22
IVUS ENHANCER (K062985)Indec Systems, Inc.2006-11-22
ORTHOVIEW (K063327)Merdian Technique, Ltd.2006-11-22
DX-SI (K063421)Agfa Corp.2006-11-22
MODIFICATION TO ACUSON ANTARES ULTRASOUND SYSTEM (K063138)Siemens Medical Solutions USA, Inc.2006-11-22
EXCELART VANTAGE ATLAS, MODEL MRT-1503 (K063361)Toshiba America Medical Systems, In.C2006-11-21
LONGPORT EPISCAN, MODEL-I-200 (K062571)Longport, Inc.2006-11-21
MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY (K062781)Symtium Corporation2006-11-21
CADI, VERSION 4 (K062237)Synca Marketing, Inc.2006-11-20
FLEX LOOP COIL SET 3T (K063373)Siemens AG2006-11-17
NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB (K062131)Barcoview2006-11-17
DEFINIUM 5000 X-RAY SYSTEM (K063283)Sedecal., Sa.2006-11-17
2MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-2NC (K063289)Chi Lin Technology Co., Ltd.2006-11-16
MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM (K063085)Siemens Medical Solutions USA, Inc.2006-11-14
IQQA-LIVER SOFTWARE (K061696)Edda Technology, Inc.2006-11-13
S-SCAN MRI SYSTEM (K063207)Esaote, S.p.A.2006-11-09
3MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-3NC (K063266)Chi Lin Technology Co., Ltd.2006-11-09
ISITE PACS, V 4. X (K063267)Stentor Inc., A Philips Medical Systems Co.2006-11-09
COLOR LCD MONITOR, RADIFORCE, MODEL RX210 (K063120)Eizo Nanao Corporation2006-11-09
CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION (K063241)Toshiba America Medical Systems, In.C2006-11-09
CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE (K062384)Isoray, Inc.2006-11-09
ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR (K062241)North American Scientific, Inc.2006-11-09
XERON PACS (K062757)Xeron Healthcare Corp.2006-11-07
SECTRA WORKSTATION, VERSION 11.1 (K063093)Sectra Imtec AB2006-11-07
ART SHIELDED BREAST APPLICATOR (K062135)Advanced Radiation Therapy, LLC2006-11-07
TSX-301A, AQUILION ONE CT SYSTEM (K063189)Toshiba America Medical Systems, In.C2006-11-03
MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES (K062454)Siemens Medi Cal Solutions, Inc.2006-11-03
MODEL CVV-001A VESSEL VIEW SOFTWARE OPTION (K063184)Toshiba America Medical Systems, In.C2006-11-03
SONARA; SONARA/TEK (K060421)Viasys Healthcare, Inc.2006-11-03
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0 (K063130)Toshibamedical Systems Corporation2006-11-02
PRISM VIEW, MODEL (K063031)Kyron Clinical Imaging, Inc.2006-11-02
XPLORER 2200 DIGITAL RADIOGRAPHIC SYSTEM (K063039)Imaging Dynamics Company , Ltd.2006-11-02
GE LOGIQ WORKS (K063006)General Electric Co.2006-11-02
EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 (K063029)E-Z-Em, Inc.2006-11-02
UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0 (K062743)Electronic Business Machine Co., Ltd. (Ebm)2006-10-31
IMT.LAB SOFTWARE (K062598)Esaote Europe B.V.2006-10-31
OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115 (K062472)Source-Ray, Inc.2006-10-31
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K062967)Accuray, Inc.2006-10-30
GYNESONICS EC6 TRANSDUCER (K061153)Gynesonics, Inc.2006-10-27
MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A (K062860)Neusoft Medical Systems Co., Ltd.2006-10-27
DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR, NAOMI (K062376)Rf Systems Lab.2006-10-27
VISAGE PACS/CS, RELEASE VERSION 4.1 (K062490)Mercury Computer Systems, Inc.2006-10-27
VISTADENT OC - VERSION 4 (K060836)Dentsply Intl., Inc.2006-10-27
AMICAS VISION SERIES PACS, MODEL 4.3 (K062477)Amicas, Inc.2006-10-27
3DNET SUITE (K063107)Biotronics3D, Ltd.2006-10-27
D-SPECT CARDIAC SCANNER SYSTEM (K062450)Spectrum Dynamics , Ltd.2006-10-20
E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50 (K062647)Omega Medical Imaging, Inc.2006-10-20
BIOLUCENT APPLICATOR KIT (K062830)Biolucent, Inc.2006-10-20
CENTARISONE RIS/PACS (K063037)Centarisone, LLC2006-10-18
SYNGO LUNG CAD (K063877)Siemens Medical Solutions USA, Inc.2006-10-18
CTL-63 AND CTL-128 SPINE ARRAY COILS (K062767)Invivo Corporation2006-10-13
CR 85-X (K062742)Agfa Corporation2006-10-13
ORTHOXP (K062634)Imaging Dynamics Company , Ltd.2006-10-06
5 MEGAPIXEL MONOCHROME LCD MONITOR, RADIFORCE GS510 (K062054)Eizo Nanao Corporation2006-10-06
ACCUSOFT, ACCUSOFT XL (K062032)Direx Systems Corp.2006-10-05
ECHELON SHOULDER COIL (K062556)Hitachi Medical Systems America, Inc.2006-10-05
BRANSIST SAFIRE (K062360)Shimadzu Corp.2006-10-05
QANGIO CT (K062386)Medis Medical Imaging Systems BV2006-10-05
SYNGO DUAL ENERGY (K062351)Siemens Medical Solutions USA, Inc.2006-10-05
XPLORER 1600 PLUS (K062586)Imaging Dynamics Company , Ltd.2006-09-29
NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM (K062451)Neusoft Medical Systems Co., Ltd.2006-09-28
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K062514)Accuray Incorporated2006-09-28
CHASE CARDIAC ANALYSIS SYSTEM (K062031)Chase Medical, LP2006-09-27
RESOLUTIONMD, VERSION 1.3 (K062164)Calgary Scientific, Inc.2006-09-22
MIMVIEWER (K062163)Mimvista Corp.2006-09-22
TRILOGY TX WITH 3RD PARTY COUCH TOP SUPPORT (K062618)Varian Medical Systems, Inc.2006-09-22
MODIFICATION TO SYNGO INSPACE 4D (K062673)Siemens AG Medical Solutions2006-09-22
EP NAVIGATOR SOFTWARE (K062650)Philips Medical Systems2006-09-21
MODIFICATION TO HEXAPOD RT COUCH TOP (K062639)Medical Intelligence Medizintechnik-GmbH-An Elekta2006-09-21
IGUIDE SYSTEM (K062611)Medical Intelligence Medizintechnik-GmbH-An Elekta2006-09-20
LEICA MODEL FL800 (K061871)Leica Microsystems, Inc.2006-09-20
IQ-SYSTEM PACS SYSTEM (K062488)Image Information Systems, Ltd.2006-09-19
DIGI-LITE TCD DEVICE (K062578)Rimed , Ltd.2006-09-18
CONNECT IMAGING PACS (K061972)Connect Imaging, Inc.2006-09-18
CRYSTALVIEW R200 (K062390)Alara, Inc.2006-09-18
GENTLE COLON (REVISION 2.0) (K061532)Rendoscopy, Inc.2006-09-18
XPLORER 1100 (K062417)Imaging Dynamics Company , Ltd.2006-09-15
PULSERA (K061685)Philips Medical Systems North America Co.2006-09-15
SEDECAL X PLUS LP PLUS (K062335)Sedecal., Sa.2006-09-14
MAMMOPAD RADIOLUCENT CUSHION (K062141)Biolucent, Inc.2006-09-13
XPLORER 1590 (K062405)Imaging Dynamics Company , Ltd.2006-09-13
VOYAGER PACS SYSTEM (K062062)Voyager Imaging2006-09-11
CTC WORKSTATION, MODEL 2200 (K062229)Medical Diagnostic Technologies, Inc.2006-09-11
BIOPSY DIGIT-AM (K062039)Giotto USA, LLC2006-09-11
SUPERDIMENSION/BRONCHUS PREMIUM 2 (K062315)Superdimension, Ltd.2006-09-08
XCELERA (K061995)Philips Medical Systems North America Co.2006-09-06
ART LAB SOFTWARE (K061961)Pie Medical2006-09-06
AIE REGION OF INTEREST IMAGE ENHANCEMENT (K062059)Advanced Image Enhancement2006-09-06
CORONIS COLOR 3MP AND MDCC 3120-DL (K061927)Barcoview2006-09-05
CORONIS 3MP AND MDCG 3120-CB (K061924)Barcoview2006-09-05
CORONIS COLOR 2MP AND MDCC 2121 (K061928)Barcoview2006-09-05
GE VANTAGE PET NEURO SOFTWARE (K062393)GE Healthcare2006-09-01
AGFA MODEL CR30-X (K062223)Agfa Corporation2006-09-01
APOLLO GAMMA CAMERA SYSTEM (K062298)Adac Laboratories2006-08-23
NOVAPACS, NOVAVIEW, NOVACARDIO, NOVAQC AND NOVAER (K061920)Novarad Corp.2006-08-21
VITREAACCESS, VERSION 1.0 (K062328)Vital Images, Inc.2006-08-21
LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000 (K061941)Elekta Instrument AB2006-08-21
CORONIS 2MP AND MDCG 2121 - CB (K061926)Barcoview2006-08-18
SONOMARK (K061560)Medical Products Manufacturing, Inc.2006-08-18
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