Atlas FDA

Radiology

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

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RecordFirmDate
NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230 (K091546)Noras Mri Products GmbH2009-06-24
GE LIGHTSPEED ACT FP16 (K091673)Ge Medical Systems, Inc.2009-06-24
BRILLIANCE DUAL ENERGY OPTION (K090462)Philips Medical Systems (Cleveland), Inc.2009-06-23
AXXENT FLEXISHIELD MINI (K090417)Xoft, Inc.2009-06-23
VISION TOOLS (K090668)Millensys2009-06-23
PORTALVISION ADVANCED IMAGING (K091209)Varian Medical Systems, Inc.2009-06-23
INTELEPACS, MODEL VERSION 3.X.X (K083520)Intelerad Medical Systems Incorporated2009-06-23
CERNER PROVISION WORKSTATION (VERSION 2.5) (K091032)Cerner Corp.2009-06-22
DEXIS SOFTWARE (K090431)Dexis, LLC2009-06-22
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K091680)Edan Instruments, Inc.2009-06-19
ARTIS ZEE / ZEEGOS WITH SW VC14 (K090745)Siemens Medical Solutions USA, Inc.2009-06-18
CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM (K091518)Mcube Technology Co., Ltd.2009-06-18
MUCHECK V8 (K091602)Oncology Data Systems, Inc.2009-06-18
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM (K091492)Varian Medical Systems, Inc.2009-06-18
OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III (K091669)Xioao Mdt Technology Co, Ltd.2009-06-18
4D INTEGRATED TREATMENT CONSOLE (K091132)Varian Medical Systems2009-06-17
DIGITAL RADIOGRAPHY CXDI-60C (K091545)Canon, Inc.2009-06-15
GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS (K091103)Hitachi Medical Systems America, Inc.2009-06-15
ONCENTRA SIMULATION 2.3 (K090706)Nucletron Corporation2009-06-15
MODIFICATION TO NORDICICE SOFTWARE (K090546)Nordicimaginglab AS2009-06-08
VITREA ENDOVASCULAR STENT PLANNING SOFTWARE (K091498)Vital Images, Inc.2009-06-05
R2 DIGITALNOW HD(DIGITALNOW HD) (K091368)Hologic, Inc.2009-06-04
X-RAY, TOMOGRAPHY, COMPUTED, DENTAL (K083917)Suni Medical Imaging, Inc.2009-06-02
DIGITAL RADIOGRAPHY MODEL CXDI-55G (K091435)Canon, Inc.2009-05-29
DIGITAL RADIOGRAPHY, MODEL CXDI-55C (K091436)Canon, Inc.2009-05-29
PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511 (K091195)Philips Medical Systems (Cleveland), Inc.2009-05-27
RADCALC SOFTWARE, VERSION 6.0 (K090531)Lifeline Software, Inc.2009-05-27
FLEXIPLAN 3D AND 3D+ (K091145)Isodose Control B.V.2009-05-27
RIC CONFORMAL SOURCE, MODEL 100 (K090321)Ri Consultants, LLC2009-05-27
GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND (K091374)Ge Medical Systems China Co., Ltd.2009-05-26
CARESTREAM DRYVIEW 5850 LASER IMAGER (K090469)Carestream Health, Inc.2009-05-22
CAAS MR FLOW 1.0 (K090155)Pie Medical Imaging BV2009-05-22
IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0 (K090461)Tomtec Imaging Systems GmbH2009-05-22
SYNGO TRUED (K091373)Siemens Medical Solutions USA, Inc.2009-05-20
UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330, (K091154)Nucletron Corporation2009-05-18
WV1417A DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM (K090062)Direct Digital Imaging Technology (Beijing), Inc.2009-05-18
MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150 (K091009)Esaote, S.p.A.2009-05-18
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS (K090672)Agfa Healthcare N.V.2009-05-18
SYNGOCIRCULATION DYNAMICPET, VERSION 1.0 (K083327)Siemens Medical Solutions USA, Inc.2009-05-18
ZIEHM VISION RFD (K083545)Ziehm Imaging, Inc.2009-05-15
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0 (K091295)Toshiba America Medical Systems, In.C2009-05-15
SYNGO US WORKPLACE (K091286)Siemens Medical Solutions USA, Inc.2009-05-15
WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS (K091073)Ultraspect , Ltd.2009-05-14
SEGMENT (K090833)Medviso2009-05-12
SYNGO RT THERAPIST CONNECT (K090683)Siemens Medical Solutions USA, Inc.2009-05-08
NEUROPET (K091269)Photodetection Systems, Inc.2009-05-08
SPEQ ULTRASOUND SYSTEM (K090505)Signostics Pty, Ltd.2009-05-07
MATCHEDFLICKER (K090266)Eyeic Corporation2009-05-06
GE VENUE 40, MODEL 5324338 (K091164)Ge Medical Systems China Co., Ltd.2009-05-05
LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM (K091160)Broncus Technologies, Inc.2009-05-05
PANTHER REALART, MODEL 4.7 (K083502)Prowess, Inc.2009-05-05
NIO 2MP (MDNG-2121) (K091172)Barco N.V.2009-05-05
MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS) (K090182)Nuclemed S.A.2009-05-04
MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K091146)Accuray, Inc.2009-05-01
OEC 9900 ELITE (K082781)Ge Healthcare Surgery2009-05-01
TXRX 1.5T CP HEAD COIL; TXRX 3T CP HEAD COIL (K091114)Quality Electrodynamics2009-05-01
COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D (K090171)E-Woo Technology2009-04-30
IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM (K090059)Saset (Chengdu), Inc.2009-04-30
SYNGO BREVIS (K090038)Siemens Medical Solutions USA, Inc.2009-04-28
ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8 (K090178)Neusoft Positron Medical Systems Co., Ltd.2009-04-24
SPEC MODEL M-31 (K090366)Source Production & Equipment Co., Inc.2009-04-22
BLUE SKY BIO PLAN, VERSION .38 (K090607)Blue Sky Bio, LLC2009-04-22
BARCO 5MP MAMMO, MODEL MDMG-5221 (K090603)Barco N.V.2009-04-22
NIO COLOR 3MP AND MDNC-3121 (K090732)Barco N.V.2009-04-20
VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWER (K083910)Vidistar, LLC2009-04-15
MD213MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR MODEL, L218TJ (K090218)Nec Display Solutions , Ltd.2009-04-15
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900 (K090912)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2009-04-15
IBA PROTON THERAPY SYSTEM - PROTEUS 235 (K083058)Ion Beam Applications S.A.2009-04-15
MD213MG 21.3 DIAGNOSTIC IMAGING LCD MONITOR - L218TL (K090215)Nec Display Solutions , Ltd.2009-04-15
P.D SOFTWARE (K083672).Decimal, Inc.2009-04-13
I OPEN 0.5T (K090873)Beijing Wandong Medical Equipment Co., Ltd.2009-04-10
DIGDOP ULTRASOUND SYSTEM (K090465)The Newman Group, LLC2009-04-08
CARESTREAM DRX-1 SYSTEM (K090318)Carestream Health, Inc.2009-04-06
PINNACLE3 SMARTARC (K090808)Philips Medical Systems, Inc.2009-04-03
YIELD MINI DOPPLER SYSTEM (K090743)Broncus Technologies, Inc.2009-04-03
INFANT CARDIAC ARRAY (K083539)Advanced Imaging Research, Inc.2009-04-03
SYNGO DUAL ENERGY WITH EXTENDED FUNATIONALLY (K083524)Siemens Medical Solutions USA, Inc.2009-04-01
ACUSON P50 ULTRASOUND SYSTEM (K083114)Siemens Medical Solutions USA, Inc.2009-03-31
AUTOSPECT (K090403)Philips Medical Systems (Cleveland), Inc.2009-03-31
CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING (K083446)Ziosoft, Inc.2009-03-31
ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024 (K090223)Icad, Inc.2009-03-31
NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER (K090553)Naviscan, Inc.2009-03-31
SENTINEL, MODEL SP-001 (K082582)C-Rad Positioning AB2009-03-30
VRAD PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM SOFTWARE (K090649)Virtual Radiologic Corporation2009-03-27
FORUM (K090439)Carl Zeiss Meditec, Inc.2009-03-25
I_OPEN 0.4T (K090433)Beijing Wandong Medical Equipment Co., Ltd.2009-03-25
CPI RAD VISION, MODEL VZW2944XX-YY (K083224)Communications & Power Industries Canada, Inc.2009-03-24
WIRELESS PORTABLE DETECTOR FD-W17 (K090625)Philips Medical Systems North America Co.2009-03-24
DIGITAL RADIOGRAPHY CXDI-40G COMPACT (K090623)Canon USA, Inc.2009-03-24
BIOGRAPH 16 TRUE POINT SYSTEMS (K083852)Siemens Medical Solutions USA, Inc.2009-03-23
CIRRUS OPEN (K090080)Mri-Tech Sp. Zo.O.2009-03-23
BRIT PACS SYSTEMS (K081168)Brit Systems, Inc.2009-03-23
DEMASQ IMAGING SPFTWARE DEVICE (K090481)Demasq Limited2009-03-19
EASY MOVING PLUS, SM-XXHF-YY (K090322)Sedecal., Sa.2009-03-17
SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64 (K090267)Midwest Rf, LLC2009-03-16
UROCARE (K090552)Neusoft Medical Systems Co., Ltd.2009-03-16
VERADIUS, MODEL 718-130 (K090590)Philips Medical Systems North America Co.2009-03-16
LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM (K090095)Broncus Technologies, Inc.2009-03-13
DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM 2-5MHZ CURVED LINEAR ARRAY, 5-10MHZ LINEAR ARRAY, 2-4MHZ PHASE ARRAY, 4-8MHZ TRANSV (K090229)Chang Gung Medical Supplies & Equipment Corp.2009-03-13
VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND (K090214)Verathon Incorporated2009-03-13
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