Atlas FDA

Radiology

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

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RecordFirmDate
SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System (K162045)FUJIFILM Sonosite, Inc.2016-08-18
Uroview FD (K161019)Pausch Medical GmbH2016-08-17
SPEC Model M23 (K161396)Source Production and Equipment Co., Inc.2016-08-17
Sumitomo Proton Therapy System (K160612)Sumitomo Heavy Industries, Ltd.2016-08-17
UST-5550-R; UST-5536-R; L43K (K152126)Hitachi Aloka Medical America, Inc.2016-08-17
PACS CORE/ENCORE (K161518)Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.2016-08-17
SUPRIA w/guideShot Option (K161748)Hitachi Medical Systems America, Inc.2016-08-17
WebPAX (K152949)Heart Imaging Technologies, LLC2016-08-17
Dell UP3216Q with QUBYX PerfectLum bundle (K162196)Qubyx Software Technologies, Inc.2016-08-15
Discovery MI (K161574)Ge Medical Systems, LLC2016-08-11
VivoSight Dx Topical OCT System (K153283)Michelson Diagnostics, Ltd.2016-08-11
CT TrueView (K160147)Philips Medical Systems Nederland B.V.2016-08-10
Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths (K160516)Varian Medical Systems, Inc.2016-08-10
SpotLight CT (K161066)Arineta , Ltd.2016-08-10
5D Viewer (K161955)Samsung Medison Co., Ltd.2016-08-10
Affirm Lateral Arm Upright Biopsy Accessory (K161575)Hologic2016-08-10
icobrain (K161148)Icometrix2016-08-09
Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) (K152224)Ion Beam Application S.A.2016-08-09
P-ARTIS (K160611)P-Cure, Ltd.2016-08-08
Philips Ingenuity CT (K160743)Philips Medical Systems (Cleveland), Inc.2016-08-08
Verza Guidance System (K160806)CIVCO Medical Instruments Co., Inc.2016-08-05
LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 (K161224)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016-08-05
Vivid iq (K161706)Ge Medical Systems Ultrasound and Primary Care Diagnostics L2016-08-05
QXLink (K161113)Vieworks Co., Ltd.2016-08-05
JointPoint (K160284)Jointpoint, Inc.2016-08-03
8ch Foot Ankle Coil (K160932)Shenzhen RF Tech Co., Ltd.2016-08-01
Senolris (K160937)GE Healthcare2016-08-01
Precision Point Biopsy Needle Guide (K160414)Corbin Clinical Resources, LLC2016-08-01
2D Quantitative Analysis (K161839)Philips Medical Systems Nederland B.V.2016-07-29
Allura Xper FD series and Allura Xper OR Table series (K161563)Philips Medical Systems Nederland B.V.2016-07-29
ACUSON NX2 Diagnostic Ultrasound Systems (K161787)Siemens Medical Solutions USA, Inc.2016-07-28
SIMPLANT Online Case Review and SIMPLANT Editor (K161118)Dentsply Sirona2016-07-28
8ch Foot Ankle Coil (K160935)Shenzhen RF Tech Co., Ltd.2016-07-28
LVivo Software Application (K161382)Diacardio, Ltd.2016-07-28
MAMMI (K161631)General Equipment For Medical Imaging2016-07-28
Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 (K161009)Toshibamedical Systems Corporation2016-07-22
MultiScan G-Arm System (K160984)Beijing East Whale Imaging Technology Co., Ltd.2016-07-20
6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System (K161359)Esaote, S.p.A.2016-07-19
Comfort Cover (K161920)Precision Dynamics Corporation2016-07-15
FDR Visionary Suite (K152294)Shimadzu Corporation2016-07-15
LEONI ORION System (K160518)Leoni Cia Cable System2016-07-14
TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System (K161525)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2016-07-13
Multi Modality Viewer (K161419)Vital Images, Inc.2016-07-13
PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory (K161163)Hitachi , Ltd.2016-07-13
syngo®.via protoNeo (Version VA10A) (K161685)Siemens Healthcare GmbH2016-07-11
S-scan (K161238)Esaote, S.p.A.2016-07-08
Cydar EV (K160088)Cydar , Ltd.2016-07-07
RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR (K161345)Sedecal., Sa.2016-07-06
SPEC Model M13 (K161395)Source Production and Equipment Co., Inc.2016-07-06
GC85A (K160997)Samsung Electronics Co., Ltd.2016-07-06
RTHawk, HeartVista Cardiac Package (K153740)Heartvista, Inc.2016-06-30
ADMIRE (K153360)Siemens Medi Cal Solutions, Inc.2016-06-29
Ablation Confirmation (K161285)Neuwave Medical, Inc.2016-06-29
OPTIS Metallic Stent Optimization E.4 SW (K160878)Lightlab Imaging, Inc.2016-06-29
SCATTER CORRECTION FOR CXDI SERIES (K153312)Canon, Inc.2016-06-28
Surgical Navigation Advanced Platform (SNAP) (K160584)Surgical Theater, LLC2016-06-28
hipEOS (K161479)Onefit Medical2016-06-28
Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System (K160853)Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)2016-06-27
Radixact Treatment Delivery System (K161146)Accuray Incorporated2016-06-24
Precision Treatment Planning System (K161136)Accuray Incorporated2016-06-24
iDMS Data Management System (K161144)Accuray Incorporated2016-06-24
Kuvia3D (K161559)4qimaging, LLC Dba Qmetrics2016-06-23
IMPAX Volume Viewing 4.0 (K161061)Agfa Healthcare N.V.2016-06-22
DBSWIN and VistaEasy Imaging Software (K161444)Duerr Dental AG2016-06-21
OEC Elite MiniView (K160131)Ge Hangwei Medical Systems Co., Ltd.2016-06-21
Advanced Medical Imaging Software Suite (KSWVWR) (K160334)Keosys Sas2016-06-21
Gold Anchor (K160209)Naslund Medical AB2016-06-21
RCT700 (K160525)Ray Co., Ltd.2016-06-20
RADspeed Pro (K152244)Shimadzu Corporation2016-06-20
Quantib Brain 1 (K153351)Quantib B.V.2016-06-17
ECG CT Gating Device (K160350)Neocoil, LLC2016-06-16
Sonic Window (K161342)Analogic Corporation2016-06-15
Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution (K160627)Qfix2016-06-14
Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T (K160618)Ge Medical Systems, LLC2016-06-09
HEPATIQ 1.1 (K161188)Hepatiq, LLC2016-06-09
BSD4343 Digital Flat Panel X-ray Detector (K160204)Bontech, Inc.2016-06-09
Aquilion ONE (TSX-305A/3) V7.3 (K160587)Toshibamedical Systems Corporation2016-06-09
X-VIEW, IMAGEN (K151137)Edlen Imaging, LLC2016-06-07
16ch Tx/Rx Knee SPEEDER (K161193)Quality Electrodynamics, LLC2016-06-02
Hermes Medical Imaging Suite v5.6 (K153056)Hermes Medical Solutions AB2016-06-01
Acclarix AX8 Diagnostic Ultrasound System (K161300)Edan Instruments, Inc.2016-05-31
CT/MR Compatible M.A.C. Interstitial GYN Template (K150979)Mick Radio-Nuclear Instruments, Inc.2016-05-31
Ez3D-i / E3 (K161246)Ewoosoft Co., Ltd.2016-05-31
3mensio Workstation (K153736)Pie Medical Imaging BV2016-05-27
Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement (K153026)Medtec, Inc. D/B/A Civco Medical Solutions2016-05-25
Planmeca ProMax 3D Max, Planmeca Maximity (K160506)Planmeca Oy2016-05-20
ViZion DR + Wireless (K160810)Viztek, LLC2016-05-20
GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System (K160065)Gemss Medical Systems Co., Ltd.2016-05-20
Trillium Oval V 5.1 MRI System (K160152)Hitachi Medical Systems America, Inc.2016-05-20
Mammo Tomosynthesis (MDMG-5221) (K161229)Barco N.V.2016-05-18
SafeCT-29 (K153331)Medic Vision Imaging Solutions2016-05-17
SonoSite iViz Ultrasound System (K161119)FUJIFILM Sonosite, Inc.2016-05-13
Diagnostic Imaging Color LCD Monitor (K161057)Nec Display Solutions , Ltd.2016-05-13
Bindex BI-100 (K152020)Bone Index Finland , Ltd.2016-05-13
EzDent-i / E2 / Prora View (K161117)Ewoosoft Co., Ltd.2016-05-13
ArcCHECK-MR (K160057)Sun Nuclear Corporation2016-05-13
Perimeter Otis™ 1.0 Optical Coherence Tomography System (K160240)Perimeter Medical Imaging, Inc.2016-05-13
LOGIQ P9 and LOGIQ P7 (K161047)GE Healthcare2016-05-05
Enovare Ultrasound System (K153620)Oreon Technologies, Inc.2016-05-05
6200 Ultrasound System and 6250 Ultrasound System (K153277)Esaote, S.p.A.2016-05-04
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