Atlas FDA

Radiology

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

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RecordFirmDate
SOMATOM Definition AS Open (VA48) (K143409)Siemens Medical Solutions USA, Inc.2015-03-26
Customer Remote Console (CRC) (K150193)Ge Medical Systems, LLC2015-03-24
Volcano iFR Modality, iFR Scout feature (K150441)Volcano Corporation2015-03-20
mDIXON XD (K143128)Philips Medical Systems Nederlands B.V.2015-03-20
Aquilion LB, TSX-201A/3, V6.0 (K150003)Toshibamedical Systems Corporation2015-03-19
Blackford Analysis Registration Product Family (K142337)Blackford Analysis, Ltd.2015-03-19
U-Lite (K143601)Sonoscanner Sarl2015-03-18
DRX-EVOLUTION (K141837)Carestream Health, Inc.2015-03-11
XIDF-AWS801, Angio Workstation, v5.31 (K142736)Toshibamedical Systems Corporation2015-03-11
Martinez Prostate Template Set (K142439)Nucletron B.V.2015-03-10
PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 113 (K141624)Varian Medical Systems, Inc.2015-03-10
Aquilion ONE Vision, v7.0 (K142465)Toshibamedical Systems Corporation2015-03-10
DR Systems Zero Download 3D Viewer (Z3D) (K143318)Dr Systems, Inc.2015-03-10
X-RAY TV SYSTEM SONIALVISION G4 (K142341)Shimadzu Corp.2015-03-06
VIEWING CLIENT MOBILE (K141536)Axon Medical Technologies Corp.2015-03-06
3.0T GEM RT Open Array (K143389)Ge Healthcare Coils (Usa Instruments, Inc.)2015-03-06
Sirius Starmobile tiara (K143537)Hitachi Medical Systems America, Inc.2015-03-06
TraumaCad Mobile Release 1.0 (K142923)Voyant Health, Ltd.2015-03-05
Vitrea, Version 7.0 Medical Image Processing Software (K150258)Vital Images, Inc.2015-03-05
ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System (K150249)Zonare Medical Systems, Inc.2015-03-04
iGuide 2.1 (K143485)Medical Intelligence Medizintechnik GmbH2015-03-04
Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System (K150087)Ge Vingmed Ultrasound AS2015-03-04
TRILLIUM Oval MR System (K142734)Hitachi Medical Systems America, Inc.2015-03-02
GE EchoPAC (K150085)Ge Vingmed Ultrasound AS2015-03-02
IRIS INTELLIGENT RETINAL IMAGING SYSTEM (K141922)Intelligent Retinal Imaging Systems, LLC2015-02-27
Syngo X-workplace SW VD10 (K143319)Siemens Medi Cal Solutions, Inc.2015-02-24
THD REVOLUTION (K141657)Thd Spa2015-02-24
Terason uSmart3300 Ultrasound System (K150148)Teratech Corp.2015-02-20
U50 Diagnostic Ultrasound System (K142511)Edan Instruments, Inc.2015-02-20
Volcano iFR Harvest Software (Offline) (K143122)Volcano Corporation2015-02-20
GM60A-32S & GM60A-40S (K150097)Samsung Electronics Co., Ltd.2015-02-19
Vienna System (K142597)Mick Radio-Nuclear Instruments, Inc.2015-02-19
Optima XR646 (K143270)Ge Hualun Medical Systems Co. , Ltd.2015-02-18
TOMTEC-ARENA TTA2 (K150122)Tomtec Imaging Systems GmbH2015-02-13
Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems (K142472)GE Healthcare2015-02-10
ACUSON P500 Diagnostic Ultrasound System (K150050)Siemens Medical Solutions USA, Inc.2015-02-09
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory (K143678)Ninepoint Medical, Inc.2015-02-06
MD322C8 31.5 Diagnostic Imaging LCD Monitor (K150145)Nec Display Solutions , Ltd.2015-02-06
CAAS A-Valve (K143044)Pie Medical Imaging BV2015-02-06
KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System (K143257)Medicatech USA2015-02-06
Digital Diagnostic X-ray System (GC80) (K143029)Samsung Electronics Co., Ltd.2015-02-04
SIGNA Creator, SIGNA Explorer (K143251)Ge Healthcare (Ge Medical Systems, LLC)2015-02-04
NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE (K140828)Brainreader Aps2015-02-04
ECHOSTAR COMFORT 1.5T MRI (K141945)Alltech Medical Systems America, Inc.2015-02-03
EmboGuide (K142273)Philips Medical Systems Nederland B.V.2015-01-30
Universal Digital Interface 2W, UDI 2W (K143232)Meridian Medical Systems, LLC2015-01-30
Ultimax-i (K143281)Toshibamedical Systems Corporation2015-01-29
S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System (K142714)Sonoscape Company Limited2015-01-29
LOGIQ P9, LOGIQ P7 (K143452)GE Healthcare2015-01-29
S22 Digital Color Doppler Ultrasound System (K142815)Sonoscape Company Limited2015-01-28
NewTom 5G (K142222)Qr S.R.L.2015-01-26
RIS500 (K143000)Ray Co., Ltd.2015-01-23
omni TRAX Active Patient Tracker (K143396)Civco Medical Instruments CO Inc Dba Civco Medical Solutions2015-01-23
EOS System (K142773)Eos Imaging2015-01-22
Mammography Color Display DP-M3010 (K143718)Canon, Inc.2015-01-22
PODIATRY X-RAY SYSTEM (K133959)Source-Ray, Inc.2015-01-22
ECHO TRUE 3D VIEWER (K142107)Echopixel, Inc.2015-01-21
iMAR (K142584)Siemens Medical Solutions USA, Inc.2015-01-16
Ultrasound Scanner System bk2300 (K143298)Bk Medical Aps2015-01-16
VM PACS WITH VM MEDICAL WORKSTATION (K141561)Visual Medica2015-01-16
EVS 4343 (K142475)DRTECH Corporation2015-01-15
SignosRT Bladder Ultrasound System (K143493)Signostics, Ltd.2015-01-14
NOBLUS DIAGNOSTIC ULTRASOUND SCANNER (K142368)Hitachi Aloka Medical, Ltd.2015-01-14
CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT (K143223)Toshibamedical Systems Corporation2015-01-12
INFX-8000V with Wireless Footswitch (K143225)Toshibamedical Systems Corporation2015-01-09
MR-CT VVA (K140587)Medis Medical Imaging Systems BV2015-01-06
IMPAX Agility (K142316)Agfa Healthcare N.V.2015-01-06
McKesson Radiology Mammography Plus (K142850)Mckesson Medical Imaging Company2015-01-06
S9 Portable Digital Color Doppler Ultrasound System (K142710)Sonoscape Company Limited2015-01-05
TE7 Diagnostic Ultrasound System (K143472)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2015-01-02
NExCT 7 (K142697)Neurologica Corporation2014-12-23
TrueBeam-TrueBeam STx-Edge (K143224)Varian Medical Systems, Inc.2014-12-19
S12 Digital Color Doppler Ultrasound System (K142474)Sonoscape Company Limited2014-12-19
SMD Sr90-1 Radionuclide Brachytherapy Source (K142701)Salutaris Medical Devices, Inc.2014-12-19
MULTIX FUSION VA30 & VA40 (K142049)Siemens Medical Solutions USA, Inc.2014-12-18
Hermes Medical Imaging Suite v5.5 (K142631)Hermes Medical Solutions AB2014-12-18
UniWeb 8.0 (K142514)Ebm Technologies Incorporated2014-12-18
GM60A-32S, GM60A-40S (K142492)Samsung Electronics Co., Ltd.2014-12-17
Radlink GPS (K142718)Radlink, Inc.2014-12-17
HEPATIQ (K142891)Hepatiq, LLC2014-12-17
RTHawk, HeartVista Workstation with RTHawk (K142997)Heartvista, Inc.2014-12-17
ArthroPlan Digital Templating Software (K142944)Arthromeda, Inc.2014-12-16
ImmersiveTouch3 and MicrovisTouch (K140860)Immersivetouch2014-12-16
EXA (K142919)Viztek, LLC2014-12-16
RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS (K142108)Brainlab AG2014-12-16
BBS REVOLUTION (K142329)Dbmedx, Inc.2014-12-15
IPACS MEDICAL IMAGE MANAGEMENT SYSTEM (K140797)Visbion Limited2014-12-12
Varian Head Frame (K142560)Varian Medical Systems, Inc.2014-12-11
MD210C3 21.3 Diagnostic Imaging LCD Monitor (K142951)Nec Display Solutions , Ltd.2014-12-10
eSie Apps Suite (K143254)Siemens Medical Solutions USA, Inc.2014-12-10
EP NAVIGATOR REL. 5.0 (K142126)Philips Medical Systems Nederland B.V.2014-12-09
H60 V2.00 Diagnostic Ultrasound System (K143264)Samsung Medison Co., Ltd.2014-12-09
Discovery MR750 3.0T (K142361)Ge Medical Systems, LLC2014-12-05
I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE] (K141701)Isoaid, LLC2014-12-05
WaterProof PROFILER (K142431)Sun Nuclear Corporation2014-12-05
QUALITY REPORTS (K142142)Sun Nuclear Corporation2014-12-05
Siemens 3.0T PROCURE Array Coil (K142676)Resonance Innovations, LLC2014-12-05
ONEFIT HIP PLANNER (K142671)Onefit Medical2014-12-05
Endovascular Stent Planning Software (K143079)Vital Images, Inc.2014-12-04
X TWIN SYSTEM (K133496)Roesys GmbH2014-12-03
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