Atlas FDA

Radiology

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

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RecordFirmDate
Digital Diagnostic Mobile X-ray System (K162278)Samsung Electronics Co., Ltd.2016-11-15
Optima XR240amx (K162990)Ge Medical Systems, LLC2016-11-15
eUnity (K161515)Client Outlook, Inc.2016-11-15
CushionCast Moldable Cushions (K162265)Izi Medical Products, LLC2016-11-15
X-MIND trium (K160166)De Gotzen S.R.L.2016-11-15
i-CAT FLX V series / KaVo 3D eXam+ V series (K162085)Imaging Sciences International2016-11-10
IPS CaseDesigner (K161634)Nobel Biocare AB2016-11-10
Raycast High Precision Lung Board Solution (K162862)Orfit Industries NV2016-11-09
dS Small Extremity 16CH 1.5T Coil (K162863)Invivo Therapeutics Corporation2016-11-07
D-SPECT Scanner, D-SPECT L Scanner (K161740)Spectrum Dynamics Medical, Ltd.2016-11-04
Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source (K162573)Source Production and Equipment Co., Inc.2016-11-04
Vitrea CT Dual Energy Image View (K161157)Vital Images, Inc.2016-11-03
MicrUs (K161968)Telemed2016-11-03
CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant (K160921)Cs Medical, LLC2016-11-03
Senographe Pristina (K162268)GE Healthcare2016-11-03
Xario 200 Diagnostic Ultrasound System V5.0 (K162155)Toshibamedical Systems Corporation2016-11-01
Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay (K162002)Zdi, Solutions, LLC2016-11-01
PaX-i3D Green Premium (Model: PCT-90LH) (K160882)VATECH Co., Ltd.2016-10-28
Arterys Software v2.0 (K162513)Arterys, Inc.2016-10-28
ClearVision ExamVue Flat Panel Detector (K160143)Jpi Healthcare, Inc.2016-10-28
G-scan Brio, S-scan (K161973)Esaote, S.p.A.2016-10-25
Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT (K162736)Siemens Medical Solutions USA, Inc.2016-10-25
vRad PACS with Mammography (K162145)Virtual Radiologic Corporation2016-10-25
syngo.via RT Image Suite (K162370)Siemens Medical Solutions USA, Inc.2016-10-25
Artemis (K162474)Eigen2016-10-21
Paragon 2 (K162687)Meridian Medical Systems, LLC2016-10-21
Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers (K160442)Neural Analytics, Inc.2016-10-21
Advanced Breast Template System (K161540)Varian Medical Systems, Inc.2016-10-20
IQM Integral Quality Monitor (also IQM) (K162629)Irt Systems2016-10-20
QuantumCam (K161674)Ddd-Diagnostic A/S2016-10-20
Green Smart (Model: PHT-35LHS) (K162660)VATECH Co., Ltd.2016-10-20
Ultrasound System SONIMAGE HS1 (K162065)Konica Minolta, Inc.2016-10-19
NOBLUS™ Ultrasound Diagnostic System (K160559)Hitachi Medical Corporation2016-10-18
16ch T/R Knee Coil (K162029)Quality Electrodynamics, LLC2016-10-18
IntelliSpace Portal Platform (K162025)Philips Medical Systems Nederlands B.V.2016-10-18
bk2300 (K161960)Bk Medical Aps2016-10-17
Infinix, INFX-8000V, V6.35 (K162614)Toshibamedical Systems Corporation2016-10-17
MedDream (K162011)Softneta Uab2016-10-14
NovaPACS (K160371)Novarad Corporation2016-10-14
ANYVIEW-500R Fluoroscopic Mobile X-Ray System (K160279)Ecotron Co., Ltd.2016-10-14
BSD3543 Digital Flat Panel X-ray Detector (K162487)Bontech, Inc.2016-10-14
MyLabSix CrystaLine (K162290)Esaote, S.p.A.2016-10-14
1717WCC / 1717WGC (K162519)Rayence Co., Ltd.2016-10-06
1012WCC, 1012WGC (K162518)Rayence Co., Ltd.2016-10-06
CuattroDR (K161937)Cuattro, LLC2016-10-06
iSR'obot MRI-US Fusion (K161109)Biobot Surgical Pte., Ltd.2016-10-06
Ziehm Solo FD (K161976)Ziehm Imaging GmbH2016-10-06
Dentiq3D (K160666)3D Industrial Imaging Co., Ltd.2016-10-05
Lumify Ultrasound System (K162549)Philips Health Care2016-10-03
RS80A Diagnostic Ultrasound System (K153539)Samsung Medison Co., Ltd.2016-10-03
Voluson E6, Voluson E8, Voluson E10 (K162269)GE Healthcare2016-10-03
kneeEOS (K161828)Onefit Medical2016-10-03
SKR 3000 (K162504)Konica Minolta, Inc.2016-10-03
PreXion3D Excelsior (K161881)Prexion Corporation2016-10-03
Esophagus Bougie Set (K161576)Varian Medical Systems, Inc.2016-10-02
DENTRIa series (K160140)Hdx Will Corp.2016-09-30
Xario 100 Diagnostic Ultrasound System, V5.0 (K162187)Toshibamedical Systems Corporation2016-09-30
8MP Color LCD Monitor (C81W+) (K162527)Shenzhen Beacon Display Technology Co., Ltd.2016-09-30
Acuson Freestyle Ultrasound System (K162417)Siemens Medi Cal Solutions, Inc.2016-09-28
Interlocked Circular Small Field Collimators, Elekta Integrated (K161984)Aktina Medical Corporation2016-09-27
DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) (K161368)Agfa Healthcare N.V.2016-09-22
ArtPix Mobile EZ2GO (K162224)Cmt Medical Technologies, Ltd.2016-09-22
CAAS MRV (K162112)Pie Medical Imaging BV2016-09-21
Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 (K161843)Toshibamedical Systems Corporation2016-09-21
Scenium (K162339)Siemens Medical Solutions USA, Inc.2016-09-21
E-CUBE 11 (K161439)Alpinion Medical Systems Co., Ltd.2016-09-21
PixelShine (K161625)Algomedica2016-09-19
5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR (K162497)Eizo Corporation2016-09-19
JiveX (K162008)Visus Technology Transfer GmbH2016-09-16
DoseCHECK (K161946)Sun Nuclear Corporation2016-09-16
TRILLIUM Oval Head Coil 32 (K162079)Hitachi Medical Systems America, Inc.2016-09-16
EBit Series Diagnostic Ultrasound System (K162172)Chison Medical Imaging Co., Ltd.2016-09-14
dS FootAnkle I6CH 1.5T Coil (K162177)Invivo Corporation2016-09-14
CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System (K162329)Philips Health Care2016-09-14
ClearRead CT (K161201)Riverain Technologies, LLC2016-09-09
PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector (K161966)Perkinelmer, Inc.2016-09-08
SonoSite iViz Ultrasound System (K162288)FUJIFILM Sonosite, Inc.2016-09-08
Symbia 6.5 (K162337)Siemens Medical Solutions USA, Inc.2016-09-08
2MP Color LCD Monitor CCL214 (CL21214) (K161895)Jvckenwood Corporation2016-09-08
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System (K162267)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2016-09-06
ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System (K162243)Siemens Medi Cal Solutions, Inc.2016-09-06
ACUSON SC2000 Diagnostic Ultrasound System (K162221)Siemens Medical Solutions Inc. Ultrasound Group2016-09-06
Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) (K161459)Varian Medical Systems, X-Ray Products-Infimed2016-09-06
SyncVision System (K161756)Volcano Corporation2016-09-05
PROcedure Rehearsal Studio (K153705)3Dsystems, Simbionix Products2016-09-02
MyLabSix Ultrasound System (K161168)Esaote Europe B.V.2016-09-02
Restore PACS (K162141)Xian Wingspan Electronic Technology Co., Ltd.2016-09-02
CareView 1500P X-ray Flat Panel Detectors (K162178)Careray Digital Medical System Co., Ltd.2016-09-01
PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector (K161942)Perkinelmer, Inc.2016-09-01
SIGNA Voyager (K161567)GE Healthcare2016-09-01
Vscan Extend (K161588)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016-08-31
MAGiC (K161397)Ge Medical Systems, LLC2016-08-31
1.5T and 3.0T 16 CH GE Shoulder Coils (K162001)Invivo Corporation2016-08-31
OnSight 3D Extremity System (K160723)Carestream Health, Inc.2016-08-30
RS80A Diagnostic Ultrasound System (K162094)Samsung Medison Co., Ltd.2016-08-26
AneurysmFlow (K160455)Philips Medical Systems Nederland B.V.2016-08-25
ResolutionMD (K161130)Calgary Scientific, Inc.2016-08-24
SOMATOM Drive (K161196)Siemens Medical Solutions USA, Inc.2016-08-24
Vantage Titan 1.5T, MRT-1510, V3.6 Software (K160632)Toshibamedical Systems Corporation2016-08-23
Sentinella 102, Sentinella 102 Horus (K162052)General Equipment For Medical Imaging (Oncovision-2016-08-18
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