Atlas FDA

Radiology

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

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RecordFirmDate
SYNGO.CT COLONOGRAPHY (K140920)Siemens Medical Solutions USA, Inc.2014-12-03
CLEARVIEW (K133373)Neusoft Medical Systems Co., Ltd.2014-12-03
Synapse 3D Liver and Kidney Analysis (K142521)Fujifilm Meidcal Systems U.S.A.,Inc.2014-12-01
ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM (K140041)Genoray Co., Ltd.2014-11-28
AQUILION PRIME, V6.00 (K141741)Toshibamedical Systems Corporation2014-11-26
WS80A Diagnostic Ultrasound System (K143089)Samsung Medison Co., Ltd.2014-11-26
GENESIS II (K133434)Dornier Medtech America, Inc.2014-11-26
SIGNA PET/MR (K142098)Ge Medical Systems, LLC2014-11-24
Atlas SPEEDER Head/Neck (K142802)Quality Electrodynamics, LLC2014-11-24
ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2 (K142197)Konica Minolta, Inc.2014-11-21
PHILIPS IQON SPECTRAL CT (K133674)Philips Healthcare (Cleveland)2014-11-21
ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1 (K142434)Siemens Medical Solutions USA, Inc.2014-11-21
2.3MP Color LCD Monitor, RadiForce MX242W (K143261)Eizo Corporation2014-11-21
Lesion-Loc Iodine I-125 Seed/Needle (K142668)Intramedical Imaging, LLC2014-11-21
AIXPLORER (K142100)Supersonic Imagine2014-11-20
Xario 200, V3.0 (K143027)Toshibamedical Systems Corporation2014-11-20
MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL (K141977)Siemens Medical Solutions USA, Inc.2014-11-19
Xario 100, V3.0 (K143046)Toshibamedical Systems Corporation2014-11-19
VARIA-NCI (K141462)Neurochaos Solutions, Inc.2014-11-19
LessRay with Tracking (K142243)Saferay Spine, LLC2014-11-18
3MP Color LCD monitor, RadiForce RS340 (K143098)Eizo Corporation2014-11-18
UNEXEF-38G ULTRASOUND SYSTEM (K131973)Toyota Tsusho Corporation2014-11-18
ERB ENDORECTAL BALLOON (K141958)Edge Medical, LLC2014-11-18
Sentinella 102; Sentinella 102 Horus (K143156)General Equipment For Medical Imaging (Oncovision-2014-11-18
SYNGO, CT LIVER ANALYSIS (K133643)Siemens Medi Cal Solutions, Inc.2014-11-13
GammaBeam 100 (K142219)Best Theratronics Limited2014-11-13
ANT MODEL 1 (K141038)Advanced Nuclide Technologies, LLC2014-11-12
Coronis Fusion 4MP LED (K143157)Barco N.V.2014-11-12
20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205) (K143076)Jvckenwood Corporation2014-11-12
SoftVue (K142517)Delphinus Medical Technologies, Inc.2014-10-31
IMPLANT STUDIO (K141570)3Shape Medical A/S2014-10-31
IQQA-BODYIMAGING SOFTWARE (K141745)Edda Technology2014-10-31
RAPIDRESULTS (K141881)Ramsoft, Inc.2014-10-31
NOVAPACS (K132853)Novarad Corp.2014-10-30
Site-Rite 6 Ultrasound System with Pinpoint GT Technology (K142443)C.R. Bard, Inc.2014-10-30
KUBTEC X250 (K141539)Kub Technologies, Inc.2014-10-29
APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0 (K141459)Toshibamedical Systems Corporation2014-10-28
E-CUBE 12 (K142884)Alpinion Medical Systems Co., Ltd.2014-10-28
E-CUBE 5 (K142733)Alpinion Medical Systems Co., Ltd.2014-10-28
PerkinElmer, XRpad 4343 F MED Flat Panel Detector (K142698)Perkinelmer, Inc.2014-10-23
Siemens 3.0 Blanket Array Coil (K142755)Resonance Innovations, LLC2014-10-23
SUPERNOVA C5 MRI SYSTEM (K131737)Liaoning Kampo Medical System Co., Ltd.2014-10-23
ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems (K142876)Siemens Medical Solutions USA, Inc.2014-10-23
RAYSTATION (K141860)Raysearch Laboratories AB2014-10-23
UNIVERSAL DIGITAL INTERFACE 2, UDI 2 (K140251)Meridian Medical Systems, LLC2014-10-22
VERADIUS UNITY (K142708)Philips Medical Systems Nethrlands BV2014-10-22
FDR D-EVO II FLAT PANEL DETECTOR SYSTEM (K142003)Fujifilm Medical System U.S.A., Inc.2014-10-21
Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System (K142618)Hitachi Aloka Medical America, Inc.2014-10-16
SYNGO CT SINGLE SOURCE DUAL ENERGY (K133677)Siemens Medical Solutions USA, Inc.2014-10-16
DX-D IMAGING PACKAGE (K142184)Agfa Healthcare N.V.2014-10-16
QUANTRA (K142037)Hologic, Inc.2014-10-10
Acuson SC2000 Diagnostic Ultrasound System (K142628)Siemens Medi Cal Solutions, Inc.2014-10-10
Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System (K142323)Ge Medical Systems Israel , Ltd.2014-10-10
LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM (K142160)GE Healthcare2014-10-10
CLARITY (K141855)Elekta , Ltd.2014-10-08
MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra (K142515)Siemens Medical Solutions USA, Inc.2014-10-08
24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244) (K142540)Jvckenwood Corporation2014-10-03
FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT (K141743)Radiology Solutions, LLC2014-10-03
FORUM GLAUCOMA WORKPLACE (K141297)Carl Zeiss Meditec, AG2014-10-03
UGEO PT60A Diagnostic Ultrasound System (K142466)Samsung Medison Co., Ltd.2014-10-03
21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220) (K142536)Jvckenwood Corporation2014-10-03
FDR D-EVO FLAT PANEL DETECTOR SYSTEM (K141765)Fujifilm Medical Systems U.S.A, Inc.2014-10-03
Varian Verification System (VVS) (K142268)Varian Medical Systems, Inc.2014-10-02
IMACOR ZURA EVO IMAGING SYSTEM (K142054)Imacor, Inc.2014-09-29
UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET (K141490)Varian Medical Systems, Inc.2014-09-26
PERFRACTION (K141800)Sun Nuclear Corporation2014-09-26
AERODR SYSTEM 2 (K141271)Konica Minolta, Inc.2014-09-26
DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T (K142085)Ge Medical Systems, LLC2014-09-26
OPERA SWING (K140380)General Medical Merate S.P.A2014-09-26
Optima XR200amx, Optima XR220amx (K142383)Ge Medical Systems, LLC2014-09-25
PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION (K133603)Philips Medical Systems2014-09-25
SURGIMAP (K141669)Nemaris, Inc.2014-09-19
VANTAGE ELAN (K141472)Toshiba America Medical Systems, In.C2014-09-19
CLEAR GUIDE ONE (K141806)Clear Guide Medical2014-09-19
EBM IDO VIEWER (K140399)Ebm Technologies USA, LLC2014-09-18
DENTAL IMAGING SOFTWARE (K141607)Trophy2014-09-18
MOBILEDIAGNOST WDR (K141895)Sedecal., Sa.2014-09-18
CORTEX ID SUITE (K141074)Ge Medical Systems, LLC2014-09-18
CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY (K141885)Minxray, Inc.2014-09-18
DISCOVERY IQ (K141477)Ge Medical Systems, LLC2014-09-18
Veenstra Instruments VDC-506 Dose Calibrator (K142325)Comecer Netherlands B.V.2014-09-18
Lung Density Analysis (K141069)Imbio, LLC2014-09-17
EMPRINT PROCEDURE PLANNING APPLICATION (K142048)Covidien, LLC2014-09-17
STEREOS WORKSTATION (K141137)Eos Imaging2014-09-15
SOMATOM SCOPE/SOMATOM SCOPE POWER (K140912)Siemens Medical Solutions USA, Inc.2014-09-15
DX-D IMAGING PACKAGE (K141602)Agfa Healthcare N.V.2014-09-12
MYLABSEVEN, MYLABALPHA (K142008)Esaote, S.p.A.2014-09-12
MYLABGAMMA (K142077)Esaote, S.p.A.2014-09-12
BIOGRAPH TRUE PET/CT FAMILY SOFTWARE (K141971)Siemens Medical Solutions USA, Inc.2014-09-12
EyeSuite Imaging (K142423)Haag-Streit AG2014-09-10
SC2000 and ACUSON X300 Diagnostic Ultrasound Systems (K142395)Siemens Medical Solutions USA, Inc.2014-09-09
XIDF-AWS801, ANGIO WORKSTATION, V5.31 (K141541)Toshibamedical Systems Corporation2014-09-08
ARTIS ZEE/ZEEGO SW VC21 (K141574)Siemens Medical Solutions USA, Inc.2014-09-05
AXXENT CERVICAL APPLICATOR (K141343)Icad, Inc.2014-09-05
SMART SEGMENTATION KNOWLEDGE BASED CONTOURING (K141248)Varian Medical Systems, Inc.2014-09-05
AQUILION ONE VISION SELF-PROPELLED SCAN BASE KIT FOR IVR-CT (K134025)Toshibamedical Systems Corporation2014-09-05
TRUE BEAM, TRUE BEAM STX, EDGE (K140528)Varian Medical Systems, Inc.2014-09-05
MOSAIQ ONCOLOGY INFORMATION SYSTEM (K141572)Impac Medical Systems, Inc.2014-09-05
SURESUBTRACTION LUNG (K133324)Toshiba Medical Systems Corporation, Japan2014-09-05
QMASTER-H/REVO (K133797)Telesystems Co., Ltd.2014-09-04
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