Atlas FDA

Radiology

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

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RecordFirmDate
EZ-Cover (K191491)Medxpress.Pro2020-06-05
QLAB Advanced Quantification Software (K200974)Philips Health Care2020-06-03
Vantage Orian 1.5T, MRT-1550, V6.0 (K193021)Canon Medical Systems Corporation2020-06-03
Thales 3D Mr Scanner (K200907)Lap GmbH Laser Applikationen2020-06-03
1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil (K201101)Neocoil, LLC2020-06-02
iMac 27 & PL 4.0 (K200889)Quantum-Spectra, LLC2020-06-02
MI View&GO (K201202)Siemens Medical Solutions USA, Inc.2020-06-02
uWS-MR (K192601)Shanghai United Imaging Healthcare Co., Ltd.2020-06-01
LV Liberty Vision Model 1 90Yttrium Brachytherapy Source (K193602)Lv Liberty Vision Corporation2020-05-29
CFP-3131, CFP-2222 (K201172)Mx Imaging, Inc.2020-05-29
DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System (K200979)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2020-05-28
Brainomix 360 e-CTA (K192692)Brainomix Limited2020-05-28
UNIEXPERT 2 PLUS (K200944)Adani2020-05-26
ACUSON Juniper Diagnostic Ultrasound System (K201130)Siemens Medical Solutions USA, Inc.2020-05-26
CariCloud (K200274)Caristo Diagnostics2020-05-21
Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System (K192879)Edan Instruments, Inc.2020-05-21
TOPAZ Mobile DR System (K201124)DRGEM Corporation2020-05-19
CUBEScan BioCon-900S (K200749)Mcube Technology Co., Ltd.2020-05-19
5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+ (K200864)Shenzhen Beacon Display Technology Co., Ltd.2020-05-19
syngo Ultrasound Apps Suite (sUSAS) (K201062)Siemens Medical Solutions USA, Inc.2020-05-18
Pristina Serena Bright (K193334)GE Healthcare2020-05-15
Syngo.CT CaScoring (K201034)Siemens Medical Solutions USA, Inc.2020-05-14
XV Lung Ventilation Analysis Software (K193293)4Dx Limited2020-05-14
PercuNav Image Fusion and Interventional Navigation (K201053)Philips Ultrasound, Inc.2020-05-14
HealthVCF (K192901)Zebra Medical Vision, Ltd.2020-05-12
Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) (K201043)Iray Technology Taicang , Ltd.2020-05-12
Biograph mMR with syngo MR E11P-AP01 system software (K200213)Siemens Medical Solutions USA, Inc.2020-05-11
Sonosite PX Ultrasound System (K200964)FUJIFILM Sonosite, Inc.2020-05-08
EZER, Portable X-ray System (K193535)Livermoretech, Inc.2020-05-07
Catalyst+, Catalyst+ HD (K200435)C-Rad Positioning AB2020-05-07
HS70A Diagnostic Ultrasound System (K200699)Samsung Medison Co., Ltd.2020-05-07
Accuvue+ (K201058)Radmedix, LLC2020-05-06
AVIEW LCS (K193220)Coreline Soft Co., Ltd.2020-05-05
uMR 780 (K193176)Shanghai United Imaging Healthcare Co., Ltd.2020-05-05
ZeeroMED View (K200546)O3 Enterprise Srl2020-05-05
Ziostation2 (K200315)Ziosoft, Inc.2020-05-05
Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W (K201004)Iray Technology Taicang , Ltd.2020-05-01
Optimized Positioning System (OPS) Insight (K192656)Corin USA2020-05-01
Azurion R2.1 (K200917)Philips Medical Systems Nederland B.V.2020-05-01
EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System (K201012)Philips Ultrasound, Inc.2020-05-01
Image Guidance System for Radiotherapy (K192405)Jiangsu Rayer Medical Technology Co., Ltd.2020-05-01
ArthrexVIP Web Portal (K193523)Arthrex, Inc.2020-04-30
Evry (K200327)Synaptive Medical, Inc.2020-04-29
Panther Stereotactic (K193459)Prowess, Inc.2020-04-27
O-arm O2 Imaging System (K200074)Medtronic, Inc.2020-04-24
NemoFAB (K192475)Software Nemotec S.L.2020-04-23
BSD3543W (K200787)Bontech Co., Ltd.2020-04-23
Acuson SC2000 Diagnostic Ultrasound System (K200585)Siemens Medical Solutions USA, Inc.2020-04-22
NinesAI (K193351)Nines, Inc.2020-04-21
uMR 570 (K200024)Shanghai United Imaging Healthcare Co., Ltd.2020-04-20
Sentinel (K200600)C-Rad Positioning AB2020-04-20
LOGIQ E10 (K200158)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2020-04-17
Opticross 35 15 MHz Peripheral Imaging Catheter (K200733)Boston Scientific Corporation2020-04-17
Caption Guidance (K200755)Caption Health2020-04-16
ARTIS Icono (K193326)Siemens Medical Solutions USA, Inc.2020-04-16
AS-10 (K200887)Canon, Inc.2020-04-15
ACUSON Sequoia Diagnostic Ultrasound System (K200707)Siemens Medical Solutions USA, Inc.2020-04-15
JiveX (K200703)Visus Health IT GmbH2020-04-14
Xelis Dental 2.0 (K193369)Infinitt Healthcare Co., Ltd.2020-04-14
AcuityPDR (K200726)Radmedix, LLC2020-04-13
CuraRad-ICH (K192167)Curacloud Corp.2020-04-13
VARO Plan (K200078)3D Industrial Imaging Co., Ltd.2020-04-10
ACUSON Freestyle Diagnostic Ultrasound System (K200644)Siemens Medical Solutions USA, Inc.2020-04-10
SIGNA Premier (K193282)Ge Healthcare (Ge Medical Systems, LLC)2020-04-10
DR-ID 1200SDK System (K200668)Fujifilm Corporation2020-04-10
Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K193215)Philips Medical Systems Nederland B.V.2020-04-10
MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System (K200001)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2020-04-09
hyperion X5, NewTom GO, X-RADiUS COMPACT (K200688)Cefla S.C.2020-04-09
PreXion3D Explorer EX (K193329)Prexion Corporation2020-04-09
ClearCalc (K193640)Radformation, Inc.2020-04-09
EchoNavigator (K200713)Philips Medical Systems Nederland B.V.2020-04-09
AIMI-Triage CXR PTX (K193300)Radlogics, Inc.2020-04-08
Orfit Aerial Couchtop (K200282)Orfit Industries NV2020-04-08
Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System (K200411)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2020-04-08
Flex Body Speeder (K200477)Quality Electrodynamics, LLC2020-04-08
Innovision Audio (K193218)Innovere Medical, Inc.2020-04-07
HS40 Diagnostic Ultrasound System (K200339)Samsung Medison Co., Ltd.2020-04-07
FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System (K200022)Livermoretech, Inc.2020-04-03
Eclipse Treatment Planning System v16.0 (K200608)Varian Medical Systems, Inc.2020-04-03
IntelePACS (K192176)Intelerad Medical Systems Incorporated2020-04-02
Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System (K200251)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2020-04-02
CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant (K192228)Cs Medical, LLC2020-04-01
LOGIQ E10s (K200119)GE Medical Systems Ultrasound and Primary Care Diagnostics2020-04-01
SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO (K200524)Siemens Medical Solutions USA, Inc.2020-04-01
Focus 43C detector, TRIMAX 43C detector (K200622)Iray Technology Taicang , Ltd.2020-04-01
Rapid ICH (K193087)Ischemaview Incorporated2020-03-31
MRI ECG Patient Cable (K192852)Ivy Biomedical Systems, Inc.2020-03-28
uMR Omega (K193200)Shanghai United Imaging Healthcare Co., Ltd.2020-03-27
CUBEScan BioCon-1100 (K200548)Mcube Technology Co., Ltd.2020-03-27
KOSMOS (K193518)EchoNous, Inc.2020-03-26
Arterys MICA (K192437)Arterys, Inc.2020-03-25
MammoScreen (K192854)Therapixel2020-03-25
syngo.CT Cardiac Planning (K200515)Siemens Medical Soultions USA, Inc.2020-03-25
RadiForce RX1270, RadiForce RX1270-AR (K200485)Eizo Corporation2020-03-23
Hepatic VCAR (K193281)GE Medical Systems SCS2020-03-20
MULTIX Impact (K193089)Siemens Medical Solutions USA, Inc.2020-03-20
Symbia 6.7 (K200474)Siemens Medical Solutions USA, Inc.2020-03-20
Viz ICH (K193658)Viz. Ai, Inc.2020-03-18
VIVIX-S VW (K200418)Vieworks Co., Ltd.2020-03-18
Shear Wave Quantificational Ultrasound Diagnostic System (K200136)Wuxi Hisky Medical Technologies Co., Ltd.2020-03-17
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