Atlas FDA

Radiology

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

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RecordFirmDate
SuRgical Planner (SRP) (K170793)Surgical Theater, LLC2018-02-12
OSCAR 15 (K172180)Genoray Co., Ltd.2018-02-09
CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System (K171755)Omega Medical Imaging, LLC2018-02-09
Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System (K173823)Summit Industries, LLC2018-02-09
Standard Catheter Set (K171631)Varian Medical Systems, Inc.2018-02-09
Leksell GammaPlan (K173791)Elekta Instrument AB2018-02-09
SENYINT Remote Consultation System (K162727)Dalian Senyint Digital Medical System Co., Ltd.2018-02-08
UNiD Spine Analyzer (K180091)Medicrea International2018-02-08
Ultrasound System SONIMAGE MX1 (K180084)Konica Minolta, Inc.2018-02-08
superDimension Navigation System V7.2 (K173244)Covidien, LLC2018-02-08
ACUSON X800 Diagnostic Ultrasound System (K180067)Siemens Medical Solutions USA, Inc.2018-02-07
eUnity (K172490)Client Outlook, Inc.2018-02-06
Insight BD (K172832)Siemens Medi Cal Solutions, Inc.2018-02-06
RS85 Diagnostic Ultrasound System (K173204)Samsung Medison Co., Ltd.2018-02-05
ProxiDiagnost N90 (K173433)Philips Medical Systems Dmc GmbH2018-02-05
MFI-Cardiac (K173512)Multifunctional Imaging, LLC2018-02-05
DRX-Revolution Nano Mobile X-ray System (K173924)Carestream Health, Inc.2018-02-05
ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System (K173981)Siemens Medical Solutions USA, Inc. Ultrasound Group2018-02-02
ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System (K173957)Siemens Medical Solutions USA, Inc.2018-02-01
ACUSON P600 Diagnostic Ultrasound System (K180039)Siemens Medical Solutions USA, Inc.2018-02-01
Vitrea Software Toshiba Package VSTP-001A (K173088)Toshibamedical Systems Corporation2018-01-31
DRAGON X SPSL4HC, DRAGON X SPSL8HC (K173299)Sedecal., Sa.2018-01-26
SyMRI (K173558)Syntheticmr AB2018-01-26
uDR 780i (K173953)Shanghai United Imaging Healthcare Co., Ltd.2018-01-26
Vantage Galan 3T, V4.6 (K173382)Toshibamedical Systems Corporation2018-01-26
Arterys Oncology DL (K173542)Arterys, Inc.2018-01-25
Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) (K171528)Avantsonic Technology Co., Ltd.2018-01-24
3D APT (K172920)Philips Medical Systems Nederland B.V.2018-01-22
PreXion3D Excelsior (K173878)Prexion Corporation2018-01-19
OnSight 3D Extremity System (K173478)Carestream Health, Inc.2018-01-19
ARIA Radiation Therapy Management (K173838)Varian Medical Systems, Inc.2018-01-17
Navigo Workstation Version 2.0 (K173054)UC-CARE , Ltd.2018-01-16
CS Imaging (K173622)Trophy2018-01-16
ImagenUniversal (K173547)Cardiovascular Imaging Technologies2018-01-12
syngo.via RT Image Suite (K173635)Siemens Medical Solutions USA, Inc.2018-01-12
Optima XR240amx, AutoGrid (K173602)Ge Medical Systems, LLC2018-01-12
GU60A & GU60A-65 (K173828)Samsung Electronics Co., Ltd.2018-01-12
Illumeo System (K173588)Philips Medical Systems Technologies , Ltd.2018-01-12
6440 Ultrasound System (K173291)Esaote, S.p.A.2018-01-12
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 (K173090)Toshibamedical Systems Corporation2018-01-11
DTX Studio diagnose (K172224)Nobel Biocare AB2018-01-11
ECHELON OVAL V6.0A MRI System (K172110)Hitachi Healthcare Americas Corporation2018-01-11
Ultra/Phonic Scanning Gel (K163026)Pharmaceutical Innovations, Inc.2018-01-09
Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems (K173021)Supersonic Imagine2018-01-09
16ch T/R Hand Wrist Coil (K173469)Quality Electrodynamics, LLC2018-01-09
Ultra/Phonic Free Conductivity Gel (K163027)Pharmaceutical Innovations, Inc.2018-01-09
Other-Sonic Transmission Gel (K163023)Pharmaceutical Innovations, Inc.2018-01-08
Ultra/Phonic Conductivity Gel (K163024)Pharmaceutical Innovations, Inc.2018-01-08
cNeuro cMRI (K171328)Combinostics OY2018-01-08
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic (K173471)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2018-01-08
ViewPoint 6 (K173456)Ge Medical Systems Ultrasound and Primary2018-01-05
Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System (K172860)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2018-01-02
Clover 50/Clover60/Clover70 Diagnostic Ultrasound System (K163712)Shenzhen Wisonic Medical Technology Co. , Ltd.2018-01-02
Medtronic O-arm O2 Imaging System (K173664)Medtronic, Inc.2017-12-29
Planmed Clarity (K163328)Planmed OY2017-12-28
MEVION S250i Proton Beam Radiation Therapy Device (K172848)Mevion Medical Systems2017-12-27
Radiomics App v1.0 (K173420)Microsoft Corp.2017-12-27
Real Time Image Gating System for Proton Beam Therapy Systems (K171049)Hitachi, Ltd. Healthcare2017-12-26
GammaPod - Model A (K172706)Xcision Medical Systems, LLC2017-12-22
Biograph mCT Family of PET/CT Systems (K173578)Siemens Medical Solutions USA, Inc.2017-12-20
LOGIQ E10 (K173555)GE Healthcare2017-12-20
LumiCoil Platinum Fiducial Marker (K173251)Boston Scientific Corporation2017-12-19
Veraview X800 (K171012)J. Morita USA, Inc.2017-12-19
MAGNETOM Amira (K173600)Siemens Medical Solutions USA, Inc.2017-12-19
E-CUBE 8 (K172732)Alpinion Medical Systems Co., Ltd.2017-12-14
2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300 (K173434)Jvckenwood Corporation2017-12-14
Infinix-i, INFX-8000V, V7.0 (K172863)Toshibamedical Systems Corporation2017-12-14
DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System (K173369)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.2017-12-13
InnoSight Diagnostic Ultrasound System (K172056)Qisda Corporation2017-12-13
Advanced Diffusion Analysis (ADA) application (K173467)Philips Medical Systems Nederland B.V.2017-12-12
Xario 200 Diagnostic Ultrasound System V6.0 (K172276)Toshibamedical Systems Corporation2017-12-12
Optima XR646 HD (K173612)Ge Hualun Medical Systems Co. , Ltd.2017-12-11
8ch Flex Suite (K172222)Shenzhen RF Tech Co., Ltd.2017-12-08
Clear Guide SCENERGY (K171677)Clear Guide Medical2017-12-08
Merge PACS (K173475)Merge Healthcare Incorporated2017-12-08
Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System (K173000)Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)2017-12-07
Lilium a-200E (K170046)Lilium Otsuka Co., Ltd.2017-12-07
NeuViz 16 Essence Multi-slice CT Scanner System (K171198)Neusoft Medical Systems Co., Ltd.2017-12-07
P20 Series Digital Color Doppler Ultrasound System (K172993)Sonoscape Medical Corp.2017-12-05
EZFluence (K171352)Radformation, Inc.2017-12-01
DUS-6000 Digital Ultrasonic Diagnostic Imaging System (K172931)Advanced Instrumentations, Inc.2017-12-01
P10 Series Digital Color Doppler Ultrasound System (K173058)Sonoscape Medical Corp.2017-12-01
Collision Check (K171350)Radformation, Inc.2017-11-29
DuoFLEX Coil Suite (K173290)Mr Instruments, Inc.2017-11-28
3.0T 16ch Breast Coil (K173377)Neocoil, LLC2017-11-28
Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant (K170946)Skanray Technologies Private Limited2017-11-24
GC85A (K172229)Samsung Electronics Co., Ltd.2017-11-22
Azurion series R1.2 (K172822)Philips Medical Systems Nederland B.V.2017-11-22
AIR Anterior Array, AIR Posterior Array (K172695)Ge Healthcare Coils (Usa Instruments, Inc.)2017-11-22
CereTom Elite (K172539)Neurologica Corporation, A Subsidiary of Samsung Electronics2017-11-22
Hermes Medical Imaging Suite v5.7 (K171681)Hermes Medical Solutions AB2017-11-21
MIM – Y90 Dosimetry (K172218)Mim Software, Inc.2017-11-21
LiverMultiScan (K172685)Perspectum Diagnostics, Ltd.2017-11-21
Hybrid3D (K171719)Hermes Medical Solutions AB2017-11-21
MDR17 Mobile Direct Radiographic System (K173018)Del Medical, Inc.2017-11-20
syngo®.via protoNeo (Version VA20) (K173378)Siemens Healthcare GmbH2017-11-20
Contour 24 (K173446)Quality Electrodynamics, LLC2017-11-17
CMS600P2 B-Ultrasound Diagnostic System (K170856)Contec Medical Systems Co.,Ltd2017-11-17
Vantage Titan 3T, MRT-3010/A7, M-Power GX (K172878)Toshiba Medical Systems Corporation, Japan2017-11-17
DIGITAL RADIOGRAPHY CXDI-410C WIRELESS (K171270)Canon, Inc.2017-11-17
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