Atlas FDA

Radiology

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

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RecordFirmDate
TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM (K103182)Genoray Co., Ltd.2011-01-14
VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM (K102915)Viewray, Incorporated2011-01-12
DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A (K103365)Ge Healthcare Coils (Usa Instruments, Inc.)2011-01-12
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM (K103645)Toshiba Medical Systems Corporation, Japan2011-01-12
BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV) (K103394)Varian Medical Systems, Oncology Systems2011-01-12
DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER (K103144)Shantou Institute of Ultrasonic Instruments (Siui2011-01-12
SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS (K103275)Siemens Medical Solutions USA, Inc.2011-01-11
6250 ULTRASOUND SYTEMS (K103152)Esaote, S.p.A.2011-01-07
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (K103512)Hologic, Inc.2011-01-07
THE ADDITION (K102683)Ob The-Addition, LLC2011-01-06
SPINEANALYER MODEL SAPOC (K103475)Optasia Medical2011-01-05
THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM (K103722)Medison Co., Ltd.2011-01-05
I-SEED (K103319)Theragenics Corp.2011-01-03
KRYSTALRAD (ATAL8) (K102285)Medicatech USA2011-01-03
KRYSTALRAD 560 (FLAATZ 560) (K102284)Medicatech USA2011-01-03
1.5T 16-CHANNEL HAND-WRIST COIL (K103149)Invivo Corporation2011-01-03
DX-D 100 (K103597)Agfa Healthcare N.V.2011-01-03
I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND (K103608)Ellex, Inc.2010-12-27
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM (K103583)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2010-12-27
PT2 VARIAN PROTON THERAPY SYSTEM (K101294)Varian Medical Systems, Oncology Systems2010-12-27
DOSEVIEW 3D (K103193)Standard Imaging, Inc.2010-12-27
DIGITAL DIAGNOSTIC X-RAY SYSTEM (K102408)DRGEM Corporation2010-12-27
3.0T METAFLEXCOIL (K103342)Neocoil, LLC2010-12-23
31P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFACE COIL 3T; 13C /1H DUAL TURNED SURFACE COIL 3T (K102348)Rapid Biomedical GmbH2010-12-22
AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM (K102027)Quantel Medical S.A.2010-12-22
SONIXTABLET ULTRASOUND SCANNER (K102997)Ultrasonix Medical Corporation2010-12-21
LEKSELL GAMMAPLAN (K103093)Elekta Instrument AB2010-12-21
STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS (K100703)Comed Co., Ltd.2010-12-21
HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON (K102889)Hitachi Medical Systems America, Inc.2010-12-20
SAFECT MODEL VER 1.0 (K100372)Medic Vision Brain Technologies, Ltd.2010-12-14
OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS (K102989)Chang Gung Medical Technology Co., Ltd. Linkou Fac2010-12-09
PRONEX (K102765)Direx Systems Corp.2010-12-07
PACENTRIC CONNECT, TRAVELER AND WEB (K100837)Fimreite Software AS2010-12-03
TOMOPHASE OCTIS (K102599)Tomophase Corporation2010-12-01
LLX240AB01 (K102587)Samsung Mobile Display Co., Ltd.2010-12-01
DIGITAL FLAT PANEL X-RAY DETECTOR (K101590)VATECH Co., Ltd.2010-11-29
AERODR SYSTEM (K102349)Konica Minolta Medical & Graphic, Inc.2010-11-24
ACCULMAING (K102849)Radiology Information Systems, Inc.2010-11-23
PVS MODEL 1.0 (K102237)Medcom GmbH2010-11-23
PENRITH ELETTRA ULTRASOUND SYSTEM (K100598)Penrith Corporation2010-11-19
20.1 INCH (51 CM) COLOR LCD MONITOR CCL208 (CDL2013A) (K092728)Totoku Electric Co., Ltd.2010-11-19
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM (K102390)Sonosite,Inc.2010-11-19
AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2 (K093891)Toshibamedical Systems Corporation2010-11-18
WIRELESS DR IMAGING OPTION-WDR1 (K102615)Ge Medical Systems, LLC2010-11-18
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K102650)Accuray Incorporated2010-11-17
CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT (K103215)Cianna Medical2010-11-15
IMPROVIS IMAGING SYSTEM (K101654)American Dental Partners, Inc.2010-11-10
MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS (K102344)Philips Medical Systems Nederland B.V.2010-11-09
EXPLORER 4D TREATMENT PLANNING SYSTEM (K101220)American Radiosurgery, Inc.2010-11-05
COMPACT TOUCH STS (K102198)Quantel Medical S.A.2010-11-05
VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM (K102393)Ge Medical System Israel , Ltd.2010-11-05
VIVID I DIAGNOSTIC ULTRASOUND SYSTEM (K102388)Ge Medical System Israel , Ltd.2010-11-04
INTEGRITY MODEL 1014284 (K102200)Elekta , Ltd.2010-11-04
DISCOVERY NM 750B (K102231)Ge Medical Systems Israel, Functional Imaging2010-11-03
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM (K102865)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2010-11-03
MUCHECK, VERSION 9.0 (K102583)Oncology Data Systems, Inc.2010-11-02
FULACCESS MODEL 1.0 (K101707)Fulcrum Medical, Inc.2010-10-29
DX-D 300 (K103050)Agfa Healthcare N.V.2010-10-29
BLADEVIEW (K101042)Accogent, LLC2010-10-29
FDR IMAGE STITCHING OPTION (K101686)Fujifilm Medical System U.S.A., Inc.2010-10-29
HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER (K102901)Hitachi Medical Systems America, Inc.2010-10-27
M5 DIAGNOSTIC ULTRASOUND SYSTEM (K102991)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2010-10-22
Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM (K102680)Control-X Medical, Inc.2010-10-22
DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX ARRAY TRANSDUCER, MODEL C3L60C (K102023)Shantou Institute of Ultrasonic Instruments (Siui2010-10-19
RPM RESPIRATORY GATING SYSTEM (K102024)Varian Medical Systems2010-10-15
BEYONDIMAGE WORKSTATION (K102435)Neusoft Medical Systems Co., Ltd.2010-10-15
AIXPLORER (K102041)Supersonic Imagine2010-10-13
GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM (K101149)Ge Vingmed Ultrasound AS2010-10-13
SYNGO RT THERAPIST CONNECT WORKSPACE, V4.2 (K102671)Siemens Medical Solutions USA, Inc.2010-10-12
IMAGYS (K102000)Keosys Sas2010-10-12
I-LOGIC INREACH SYSTEM (K102604)Superdimension, Ltd.2010-10-07
4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ (K101166)GE Healthcare2010-10-07
VOLPARA, VERSION 1.3 (K102556)Matakina Technology Limited2010-10-07
TELERADPRO (K102476)Vidar Systems Corp.2010-10-07
D2RF DIGITAL DYNAMIC REMOTE SYSTEM (K102529)Stephanix Radiological Systems2010-10-07
MIE SCINTRON GAMMA CAMERA SYSTEMS (K101768)Miegmbh2010-10-05
GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND (K102256)Ge Medical Systems China Co., Ltd.2010-10-05
IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO (K101813)Imris, Inc.2010-10-05
DIGITAL RADIOGRAPHY SYSTEM, MODELS GALAXY 900 AND 1600 (K093816)Medien International Co, Ltd.2010-10-05
SYNGO DYNAMICS, VERSION 9.0 (K102150)Siemens Medical Solutions USA, Inc.2010-10-05
GE LOGIQ P6/P6 PRO (K101874)GE Healthcare2010-10-05
GE ECHOPAC MODEL BT10 (K101324)Ge Vingmed Ultrasound AS2010-10-05
MIRADA RT (K102687)Mirada Medical, Ltd.2010-10-04
MAGNETOM AERA; MAGNETOM SKYRA (K101347)Siemens Medical Solutions USA, Inc.2010-10-01
XIO RTP SYSTEM (K102216)Computerized Medical Systems, Inc.2010-10-01
XELIS DENTAL (K102684)Infinitt Co., Ltd.2010-10-01
GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM (K102104)Wipro GE Healthcare Private, Ltd.2010-10-01
3D SCANNER, MODEL 1230 (K101992)Sun Nuclear Corp.2010-10-01
CALYPSO SYSTEM WITH DYNAMIC EDGE GATING (K102373)Calypso Medical Technologies, Inc.2010-09-30
A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM (K101337)Sonoscape Company Limited2010-09-30
EP NAVIGATOR R3 (K101311)Philips Medical Systems North America Co.2010-09-30
ENSITE VERISMO SEGMENTATION TOOL V.2.0 (K101697)St Jude Medical2010-09-22
UROSTATION 3D PROSTATE SUITE (K100793)Koelis2010-09-22
SHIMADZU COLLIMATOR R-300 (K101039)Shimadzu Corp.2010-09-20
SC2000 DIAGNOSTIC ULTRASOUND SYSTEM (K102017)Siemens Medical Solutions USA, Inc.2010-09-20
ECO SUPERGEL (K101429)Ceracarta Spa2010-09-15
IMIX PANORAD AND SOMARAD (K101435)Imix Adr Finland OY2010-09-15
EMBRACE (K101373)Izi Medical Products, Inc.2010-09-15
INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V (K101868)Toshiba America Medical Systems, In.C2010-09-07
BIOGRAPH MCT FAMILY (K101550)Siemens Medical Solutions USA, Inc.2010-09-03
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