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Radiology

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

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RecordFirmDate
Us2.v2 (K233676)Eko.Ai Pte Ltd. D/B/A Us2.Ai2024-04-01
AlignRT Plus (K233622)Vision Rt, Ltd.2024-03-29
LUNA 3D (K232031)Lap GmbH Laser Applikationen2024-03-29
AVIEW CAC (K233211)Coreline Soft Co., Ltd.2024-03-29
MAGNETOM Viato.Mobile (K240608)Siemens Medical Solutions USA, Inc.2024-03-29
LCD Monitors C310S, G310S, C316S, G316S, C616W (K240310)Shenzhen Beacon Display Technology Co., Ltd.2024-03-29
FDR Visionary Suite (K233719)Shimadzu Corporation2024-03-28
Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) (K240284)Shenzhen Browiner Tech Co., Ltd.2024-03-28
NAEOTOM Alpha (K233657)Siemens Medical Solutions USA, Inc.2024-03-28
OEC 3D (K233669)Ge Oec Medical Systems, Inc.2024-03-28
CARPL (CARPL) (K232891)Carpl Ai, Inc.2024-03-27
MAMMOMAT B.brilliant (K233539)Siemens Medical Solutions USA, Inc.2024-03-27
SyMRI (K233733)Syntheticmr AB (Publ.)2024-03-26
SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed (K233650)Siemens Medical Solutions USA, Inc.2024-03-26
Modus IR (K231986)Synaptive Medical, Inc.2024-03-25
Cube Navigator (K240620)Medical Templates AG2024-03-25
MAGNETOM Terra; MAGNETOM Terra.X (K232322)Siemens Medical Solutions USA, Inc.2024-03-22
uMR Omega (K240540)Shanghai United Imaging Healthcare Co., Ltd.2024-03-22
syngo.CT Brain Hemorrhage (K232431)Siemens Medical Solutions USA, Inc.2024-03-22
Digital Ultrasonic Diagnostic Imaging System (Model: F6) (K231930)Guangdong Youkey Medical Co., Ltd.2024-03-22
AI-Rad Companion (Pulmonary) (K233753)Siemens Healthcare GmbH2024-03-21
EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) (K234090)Surgvision GmbH2024-03-20
nCommand Lite System (K233660)Ionic Health2024-03-18
X-Clever (ASHK100G) (K233599)Lg Electronics.Inc2024-03-18
CINA-ASPECTS (K233342)Avicenna.Ai2024-03-15
CIARTIC Move (VB10) (K233748)Siemens Medical Solutions USA, Inc.2024-03-15
CAS-One IR (K232022)Cascination AG2024-03-13
CINA-iPE (K233968)Avicenna.Ai2024-03-13
MRCP+ version 2 (MRCP+ v2) (K233930)Perspectum2024-03-13
DRX-Evolution Plus System (K233381)Carestream Health, Inc.2024-03-12
0909FCC, 0909FCC-HS (K240371)Rayence Co., Ltd.2024-03-07
Voluson Signature 20, Voluson Signature 18 (K233692)GE Medical Systems Ultrasound and Primary Care Diagnostics2024-03-07
EdgeFlow UH10 (K231677)Edgecare, Inc.2024-03-06
Autofuse (K233572)Pymedix2024-03-06
Overjet Caries Assist-Pediatric (K233738)Overjet, Inc.2024-03-04
BoneMRI (K233030)Mriguidance B.V.2024-03-01
IMAGEnet6 Ophthalmic Data System (K232828)Topcon Corporation2024-03-01
iCAS-LV (K231690)Highrad , Ltd.2024-03-01
MAGNETOM Cima.X Fit (K232765)Siemens Medical Solutions USA, Inc.2024-02-29
inHEART Models (K231683)Inheart, Sas2024-02-29
CT Cardiomegaly (K232613)Innolitics, LLC2024-02-28
Overjet Charting Assist (K233590)Overjet, Inc.2024-02-23
RADspeed Pro (K233722)Shimadzu Corporation2024-02-23
Revolution Ascend Sliding (K233749)Ge Hangwei Medical Systems Co., Ltd.2024-02-22
HD60 Series Ultrasound Diagnostic System (K233439)Qingdao Hisense Medical Equipment Co., Ltd.2024-02-21
BD Prevue™ II Peripheral Vascular Access System (K240146)Bard Access Systems, Inc.2024-02-18
Zenition 30 (K232420)Philips Medical Systems Nederland B.V.2024-02-16
Contour Hand/Wrist (Q7000232) (K233652)Quality Electrodynamics2024-02-16
Contour Shoulder (K233656)Quality Electrodynamics2024-02-15
MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert); P12 Plus Digital Color Doppler Ultrasound System (P12 Plus); P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus); P9 Plus Ultrasound Diagnostic System (P9 Plus); P3 Plus Ultrasound Diagnostic System (P3 Plus) (K231659)Medisono2024-02-15
Medical Monitor (21HQ613D) (K240130)Lg Electronics.Inc2024-02-15
InVision™ 1.5 Surgical Theatre (K240157)Deerfield Imaging, Inc.2024-02-15
Radiography 7000 M (K233678)Philips Medical Systems Dmc GmbH2024-02-14
EXPD 4343S (K232082)DRTECH Corporation2024-02-13
QOCA® image Smart RT Contouring System (K231855)Quanta Computer, Inc.2024-02-13
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System (K233788)Philips Ultrasound, LLC2024-02-13
Mimics Cardiac Planner (K233217)Materialise NV2024-02-12
Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) (K233401)Eieling Technology Limited2024-02-12
Aid-U (K231662)Iaid2024-02-08
Leksell GammaPlan (LGP) (K232854)Elekta Solutions AB2024-02-08
HealthFLD (K233080)Nano-X AI , Ltd.2024-02-08
neuro42 MRI System (K232644)Neuro42, Inc.2024-02-08
5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S) (K233897)Shenzhen Beacon Display Technology Co., Ltd.2024-02-06
Viz HDS, Viz Volume Plus, Viz ICH+ (K232363)Viz. Ai, Inc.2024-02-05
Ziehm Vision RFD (K240099)Ziehm Imaging GmbH2024-02-05
Smart Fit Knee 3.0T (K233600)Philips Healthcare (Suzhou) Co., Ltd.2024-02-05
CAAS MR Solutions (K232007)Pie Medical Imaging BV2024-02-01
Augmented Reality Application (K232339)Sira Medical, Inc.2024-02-01
Kelowna GYN and Crook Prostate Templates (K232949)Varian Medical Systems, Inc.2024-02-01
CEPHX- Cephalometric Analysis Software (K231396)Orca Dental AI , Ltd.2024-01-31
Ziehm Vision FD (K240020)Ziehm Imaging GmbH2024-01-30
Gem Flow Now (GEM2770-FN) (K233394)Synovis Micro Companies Alliance2024-01-28
Ziehm Solo FD (K234109)Ziehm Imaging GmbH2024-01-26
BreView (K233714)GE Medical Systems SCS2024-01-25
Axial3D Cloud Segmentation Service (K231607)Axial Medical Printing Limited2024-01-24
Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System (K233195)Canon Medical Systems Corporation2024-01-24
Rapid ASPECTS (v3) (K232156)Ischemaview, Inc.2024-01-19
SIGNA Champion (K233728)Ge Healthcare (Tianjin) Company Limited2024-01-19
ThinkQA (Edition 2) (K231573)Dosisoft SA2024-01-18
uEXPLORER (K231762)Shanghai United Imaging Healthcare Co., Ltd.2024-01-18
NemoScan (K232698)Software Nemotec S.L.2024-01-18
Radify Triage (K231871)Envisionit Deepai, Ltd.2024-01-17
FlexView Diagnostic (v1.1.20) (K233226)Radical Imaging, LLC2024-01-17
Clear Guide SCENERGY (K234030)Clear Guide Medical2024-01-17
Delta4 Insight (K223234)Scandidos AB2024-01-16
Rapid (6.0) (K233512)Ischemaview, Inc.2024-01-16
Fibresolve (DEN220040)Imvaria, Inc.2024-01-12
Biograph VK10 (K233677)Siemens Medical Solutions USA, Inc.2024-01-12
PROBEAT-FR (K232032)Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha2024-01-12
ProxiDiagnost N90 / Precision CRF (706110, 706400) (K233945)Philips Medical Systems Dmc GmbH2024-01-11
U-Lite PRO (K232285)Sonoscanner Sarl2024-01-11
Dental Cone-beam Computed Tomography (K232710)Yian Medical Technology (Haining) Co., Ltd.2024-01-09
DASI Dimensions (V1.0) (K231324)Dasi Simulations2024-01-08
LungQ v3.0.0 (K232412)Thirona BV2024-01-08
InkSpace Imaging Small Body Array (K233444)Inkspace Imaging, Inc.2024-01-08
VEA Align (K231917)Eos Imaging2024-01-05
ArcherQA (V1.0) (K231273)Wisdom Technologies., Inc.2024-01-05
Butterfly iQ3 Ultrasound System (K232808)Butterfly Network, Inc.2024-01-04
syngo.CT Applications (K232136)Siemens Medical Solutions USA, Inc.2024-01-04
Horos MD™ (K232589)Icat Solutions, Ltd.2024-01-03
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