Atlas FDA

Radiology

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

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RecordFirmDate
MULTICAM 3000 ECO (K132347)Inter Medical Medizintechnik GmbH2013-11-20
I2C (K132847)Ion Beam Applications S.A.2013-11-20
MRI MARKER (K131689)C4 Imaging, LLC2013-11-20
DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM (K132779)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2013-11-19
SUMITOMO PROTON THERAPY SYSTEM (K130426)Sumitomo Heavy Industries, Ltd.2013-11-19
DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) (K132261)Ge Medical Systems, LLC2013-11-18
VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION (K133142)Volcano Corporation2013-11-15
MAGNETOM AERA (K132951)Siemens Medical Solutions USA, Inc.2013-11-15
DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T (K132376)Ge Healthcare (Ge Medical Systems, LLC)2013-11-15
DOSIMETRY CHECK VERSION 4 RELEASE 1 (K132605)Math Resolutions, LLC2013-11-14
DIGITAL COLOR DOPPLER ULTASOUND SYSTEM (K132527)Sonoscape Company Limited2013-11-14
BIOGRAPH MMR (K133226)Siemens Medical Solutions USA, Inc.2013-11-12
INFINIX ANGIO WORKSTATION W/DTS SOFTWARE (K132106)Toshiba America Medical Systems, In.C2013-11-12
GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS (K132294)Radiology Solutions, LLC2013-11-12
VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10 (K132913)GE Healthcare2013-11-08
CLARISO PACS (K132799)Clariso, Inc.2013-11-07
AQUILION ONE VISION, V6.0 (K132222)Toshibamedical Systems Corporation2013-11-07
G-ARM MULTISCAN SYSTEM (K131423)Beijing East Whale Imaging Technology Co., Ltd.2013-11-07
DICOMPACS DX-R WITH FLAT PANEL (K131211)Oehm Und Rehbein GmbH2013-11-05
X-PORTE ULTRASOUND SYSTEM (K133134)FUJIFILM Sonosite, Inc.2013-11-04
RAYSCAN A-EXPERT 3D (K131695)Ray Co., Ltd.2013-11-01
KLARITY VACUUM BAG, KLARITY MOLD CUSHION (K132124)Klarity Medical Products, LLC2013-11-01
QUIET/SILENT SCANNING SUITE (K132831)Siemens Medical Solutions USA, Inc.2013-11-01
PAXERAPACS (K132586)Paxeramed2013-10-31
UNIQUE (K132705)Varian Medical Systems, Inc.2013-10-31
STENTBOOST REL. 4 (K132305)Philips Medical Systems Nederland B.V.2013-10-30
MULTIVIEW (K132316)Hologic, Inc.2013-10-30
DIAGNOSTIC ULTRASOUND SYSTEM (K132059)Advanced Instrumentations, Inc.2013-10-25
MAMMOGRAPHY VIEWER SMV658 (K132188)Fujifilm Medical System U.S.A., Inc.2013-10-25
ACUSON S1000 / S2000 / S3000 (K132804)Siemens Medical Solutions USA, Inc. Ultrasound Gro2013-10-24
DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM (K132636)Smith & Nephew, Inc.2013-10-17
IMAGENET 5 PC SOFTWARE SYSTEM (K132438)Topcon Medical Systems, Inc.2013-10-17
SITE-RITE VISION II ULTRASOUND SYSTEM (K132942)C.R. Bard, Inc.2013-10-17
VANTAGE TITAN 3T (K132160)Toshibamedical Systems Corporation2013-10-16
.DECIMAL PROTON APERTURE (K132236).Decimal, Inc.2013-10-16
ACUSON S2000 AND S3000 (K130881)Siemens Medical Solutions USA, Inc.2013-10-11
HIGH ENERGY LINEAR ACCELERATOR (K131807)Varian Medical Systems, Inc.2013-10-11
SYNERGY ODM (K132667)Topcon Medical Systems, Inc.2013-10-09
PHILIPS PIXIUM 4343RC (K131483)Philips Medical Systems Dmc GmbH2013-10-07
S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM (K132768)Sonoscape Company Limited2013-10-04
UGEO H60 DIAGNOSTIC ULTRASOUND SYSTEM (K132861)Samsung Medison Co., Ltd.2013-10-04
ISCHEMA VIEW RAPID (K121447)Ischemaview, Inc.2013-10-04
DICOM VIDEO (K132183)Bar Code Computer, Ltd.2013-10-03
AMCAD-UT DETECTION MODEL 2.0 (K122536)Lin & Associates, LLC2013-10-03
ANYSCAN-S SPECT IMAGING SYSTEM (K131625)Absolute Imaging Solutions2013-10-03
BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY (K132097)Best Medical International, Inc.2013-09-30
AIRO CT SYSTEM (K131431)Mobius Imaging, LLC2013-09-26
NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS (K131795)Orfit Industries NV2013-09-26
ESTEYA (K132092)Nucletron B.V.2013-09-26
ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM (K132654)Siemens Medical Solutions USA, Inc. Ultrasound Gro2013-09-26
PROTURA COUCH SOFTWARE (K132084)Med-Tec, Inc. D/B/A Civco Medical Solutions2013-09-26
SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI) (K131885)GE Medical Systems SCS2013-09-26
ECLIPSE TREATMENT PLANNING SYSTEM (K131891)Varian Medical Systems, Inc.2013-09-25
NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD) (K131873)MethodSense, Inc.2013-09-25
XVI R5.0 (K131965)Elekta Limited2013-09-25
AIXPLORER (K132171)Supersonic Imagine2013-09-24
VOLUSON I/E (K131937)GE Healthcare2013-09-24
BRILLIANCE ICT (K131773)Philips Healthcare (Cleveland)2013-09-24
AIXPLORER (K132274)Supersonic Imagine2013-09-24
GE ECHOPAC (K131685)Ge Vingmed Ultrasound AS2013-09-24
EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION, (K131161)CIVCO Medical Instruments Co., Inc.2013-09-17
DIGITAL FLAT PANEL X-RAY DETECTOR (K131114)Rayence Co., Ltd.2013-09-17
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K131830)Edan Instruments, Inc.2013-09-17
CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT (K131977)GE Healthcare2013-09-17
QXLINK (K132302)Vieworks Co., Ltd.2013-09-12
XPERCT REL. 3 (K130893)Philips Medical Systems Nederland B.V.2013-09-06
JUSHA-C31 MEDICAL DISPLAY (K131389)Nanjing Jusha Display Technology Co., Ltd.2013-09-06
KOSTEC MEDICAL GRADE LDC MONITORS (K123944)Kostec Co., Ltd.2013-09-05
5MP GRAYSCALE LCD DISPLAY (K132610)Shenzhen Beacon Display Technology Co., Ltd.2013-09-04
ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS (K132045)Ge Hungary Kft2013-09-04
OPTIMA CT660 (K131576)Ge Medical Systems, LLC2013-08-30
SWIP (K131241)Philips Medical Systems Nederland B.V.2013-08-30
MD242C2 24 DIAGNOSTIC IMAGING LCD MONITOR (K132587)Ned Display Solutions , Ltd.2013-08-29
EZDENTI-I; E2; PRORA VIEW (K131594)Ewoosoft Co., Ltd.2013-08-29
CR 12-X DIGITIZER (K131408)Agfa Healthcare N.V.2013-08-29
SYNGO CT PULMO 3D (K123540)Siemens Medical Systems, Inc.2013-08-29
EZ3D-I, E3 (K131616)Ewoosoft Co., Ltd.2013-08-29
MAVEN PRO (K130242)Nsequence2013-08-29
OMNI-VUE 2 SYSTEM (K130374)Genesis Digital Imaging, Inc.2013-08-29
XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM (K131507)Toshibamedical Systems Corporation2013-08-28
SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM (K131582)Sensus Healthcare2013-08-28
LOGIQ S8 (K131527)GE Healthcare2013-08-26
AERODR SYSTEM WITH P-31 (K130936)Konica Minolta Medical & Graphic, Inc.2013-08-22
3DVH (K131862)Sun Nuclear Corporation2013-08-21
EPIQ DIAGNOSTIC ULTRASOUND SYSTEM (K132304)Philips Ultrasound, Inc.2013-08-21
CORVIEW (K131158)Marrek, Inc.2013-08-21
JUSHA-M32 MEDICAL DISPLAY (K131391)Nanjing Jusha Display Technology Co., Ltd.2013-08-21
SURESUBTRACTION ORTHO (K130960)Toshibamedical Systems Corporation2013-08-20
UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEM (K132228)Samsung Medison Co., Ltd.2013-08-20
SYNGO.MR GENERAL; SYNGO.MR CARDIOLOGY; SYNGO.MR VASCULAR (K130749)Siemens Medical Solutions USA, Inc.2013-08-20
MAPCHECK2, ARCCHECK (K131466)Sun Nuclear Corporation2013-08-20
SYMBIA (K131634)Siemens Medical Solutions USA, Inc.2013-08-16
ORTHOVISION (K131570)Ewoosoft Co., Ltd.2013-08-15
DC-8/ DC-8 PRO/ DC-8 CV/ DC-8 EXP/ DC-8S DIAGNOSTIC ULTRASOUND SYSTEMS (K132341)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2013-08-15
LVIVO EF SYSTEM (K130779)Diacardio, Ltd.2013-08-15
QLAB QUANTIFICATION SOFTWARE (K132165)Philips Ultrasound, Inc.2013-08-09
ACTIVE BREATHING COORDINATOR (K131313)Aktina Medical Corp.2013-08-07
THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL (K130743)Ortho Kinematics, Inc.2013-08-06
EPIDOSE (K131704)Sun Nuclear Corporation2013-08-05
CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE (K131305)Chison Medical Imaging Co., Ltd.2013-08-01
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