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Radiology

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

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RecordFirmDate
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis (K223028)Shanghai United Imaging Healthcare Co., Ltd.2023-02-16
Digital Radiography CXDI-CS01 (K230175)Canon, Inc.2023-02-15
Versana Essential (K223407)GE Medical Systems Ultrasound and Primary Care Diagnostics2023-02-15
8ch T/R Knee Coil (K223225)Shenzhen RF Tech Co., Ltd.2023-02-14
SIGNA Victor (K223439)Ge Healthcare (Tianjin) Company Limited2023-02-13
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System (K223387)Samsung Medison Co., Ltd.2023-02-13
ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System (K230207)Siemens Medical Solutions USA, Inc.2023-02-13
syngo.via View&GO VA40A (K230196)Siemens Healthcare GmbH2023-02-13
S90 Exp Series Digital Color Doppler Ultrasound System (K222596)Sonoscape Medical Corp.2023-02-10
MD.ai Viewer (K223425)Mdai, Inc.2023-02-10
Pro-Tx Endorectal Balloon (PROT-25) (K223249)Dxtx Medical, Inc.2023-02-10
Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound System (K222928)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2023-02-07
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System (K223735)Siemens Medical Solutions USA, Inc.2023-02-06
Videa Perio Assist (K223296)Videahealth, Inc.2023-02-06
Digital Flat Panel Detector (K230059)Ray Imaging Technology (Haining) Limited2023-02-03
Atomica Planner (K230012)Atomica Technology, Inc.2023-02-02
Oncospace (K222803)Oncospace, Inc.2023-02-02
Rapid RV/LV (K223396)Ischemaview, Inc.2023-02-01
BriefCase (K230020)Aidoc Medical , Ltd.2023-02-01
LVivo IQS (K222970)Dia Imaging Analysis, Ltd.2023-02-01
31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil (K213480)Rapid Biomedical GmbH2023-02-01
RefleXion Medical Radiotherapy System (RMRS) (DEN220014)Reflexion Medical, Inc.2023-02-01
Sim&Size (K222664)Sim&Cure2023-01-27
QOCA image Smart CXR Image Processing System (K221868)Quanta Computer, Inc.2023-01-27
14HQ721G-B (K223546)Lg Electronics.Inc2023-01-27
ECHELON Oval V6.2 MRI System (K221619)Fujifilm Healthcare Corporation2023-01-26
RMF-2000 (K220073)DRTECH Corporation2023-01-26
Ortho Device, ADAPTIX 3D Orthopedic Imaging System (K221949)Pausch Medical GmbH2023-01-26
Clarius AI (K222406)Clarius Mobile Health Corp.2023-01-23
DRX - Compass (K223842)Carestream Health, Inc.2023-01-20
Advanced MyHip Planner (K221725)Medacta International S.A.2023-01-20
PerfusionGo Plus (K221627)Yukun (Beijing) Technology Co., Ltd.2023-01-19
PercuNav Image Fusion and Interventional Navigation System (K223804)Philips Ultrasound, LLC2023-01-18
TruPlan Computed Tomography (CT) Imaging Software (K222593)Circle Cardiovascular Imaging, Inc.2023-01-18
Halcyon, Ethos Radiotherapy System (K222941)Varian Medical Systems, Inc.2023-01-17
Elucis (K220649)Realize Medical, Inc.2023-01-17
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS (K223794)Cefla S.C.2023-01-17
MIM – Additional Tracers (K223800)Mim Software, Inc.2023-01-17
MR Diffusion Perfusion Mismatch V1.0 (K223502)Olea Medical2023-01-13
Contour Knee (K223429)Quality Electrodynamics, LLC2023-01-13
PreXion3D Expedition (K222150)Prexion Corporation2023-01-12
MAMMOVISTA B.smart (VB70) (K223363)Siemens Medical Solutions USA, Inc.2023-01-12
AIBOLIT 3D+ (K222458)Aibolit Technologies, LLC2023-01-12
Transducer Probe Cover (K221278)Hony Medical Co., Ltd.2023-01-11
RadianceTx Radionuclide Brachytherapy Source (K223465)Radiance Therapeutics, Inc.2023-01-11
21HQ513D (K223789)Lg Electronics.Inc2023-01-09
Vitrea Software Package, VSTP-002A (K223336)Canon Medical Systems Corporation2023-01-09
Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P (K222787)Chongqing Sunkingdom Medical Instrument Co., Ltd.2023-01-09
TECHFIT Diagnostic Models (K222577)Techfit Digital Surgery, Inc.2023-01-06
OnyxCeph (K213263)Image Instruments GmbH2023-01-04
3.0T 16ch AIR AA (K223378)Ge Healthcare Coils (Usa Instruments, Inc.)2023-01-03
PeekMed web (v1) (K222767)Peek Health, S.A.2022-12-30
Cyware 4H and Cysart 4H (K221796)Abys Medical2022-12-30
aprevo® Digital Workflow (K222195)Carlsmed, Inc.2022-12-30
X-ray Flat Panel Detectors (EverestView 4343X) (K223687)Careray Digital Medical Technology Co., Ltd.2022-12-30
nView s1 with nav option (K221344)Nview Medical2022-12-28
BioXmark (DEN220017)Nanovi A/S2022-12-23
XENOVIEW 3.0T Chest Coil (K212239)Polarean, Inc.2022-12-23
MR 5300 and MR 7700 R11 MR Systems (K223442)Philips Medical Systems Nederlands B.V.2022-12-23
AVIEW (K214036)Coreline Soft Co., Ltd.2022-12-23
Xenoview VDP (K223071)Polarean, Inc.2022-12-23
Philips CT 3500 (K223311)Philips Healthcare (Suzhou) Co., Ltd.2022-12-22
Biograph Vision Quadra PET/CT System (K223547)Siemens Medical Solutions USA, Inc.2022-12-22
8MP Color LCD Monitor CL-R813 (K222864)Jvckenwood Corporation2022-12-21
VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP (K221911)Vinno Technology (Suzhou) Co.,Ltd2022-12-21
AirRay (K222896)Poskom Co., Ltd.2022-12-20
Overjet Calculus Assist (K220928)Overjet, Inc.2022-12-16
Saige-Density (K222275)DeepHealth, Inc.2022-12-16
BrainInsight (K223268)Hyperfine, Inc.2022-12-16
Small Field Applicator (K220883)Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha2022-12-15
3D-SHAPER (K220822)3D-Shaper Medical S.L2022-12-09
InkSpace Imaging Body Array (K223487)Inkspace Imaging, Inc.2022-12-08
8ch Wrist Coil (K223239)Shenzhen RF Tech Co., Ltd.2022-12-08
Cios Select (VA21) Flat Panel (K223410)Siemens Medical Solutions USA, Inc.2022-12-07
Ultrasound System 2300 (K222441)Bk Medical Aps2022-12-07
Cios Select (VA21) Image Intensifier (K223409)Siemens Medical Solutions USA, Inc.2022-12-06
MedDream (K222320)Softneta Uab2022-12-06
Swoop Portable MR Imaging System (K223247)Hyperfine, Inc.2022-12-06
R2 Studio Q/RCT820 (K222219)Megagen Implant Co., Ltd.2022-12-06
ClearRead CT (K221612)Riverain Technologies, Inc.2022-12-05
BriefCase (K222692)Aidoc Medical , Ltd.2022-12-05
CardioGraphe (K213465)Arineta , Ltd.2022-12-02
ProBeam 360° Proton Therapy System (K221791)Varian Medical Systems, Inc.2022-12-01
Bolt Navigation System (K213768)Circinus Medical Technology, LLC2022-12-01
TorchTM Software (K220630)Voximetry, Incorporated2022-11-28
Wireless/Wired X-Ray Flat Panel Detectors (K223009)Allengers Medical Systems Limited2022-11-27
VSI HoloMedicine (K213215)Apoqlar GmbH2022-11-25
CINA (K221716)Avicenna.Ai2022-11-22
Denti.AI Auto-Chart (K222054)Denti.Ai Technology, Inc.2022-11-22
Vision 2, EVARVision, TrackVision 2, HeartVision 2 (K223152)GE Medical Systems SCS2022-11-22
AccuCTP (K220663)ArteryFlow Technology Co., Ltd.2022-11-22
VitroPRO (K222052)CIVCO Medical Instruments Co., Inc.2022-11-22
DynamicIQ (K222895)GE Medical Systems SCS2022-11-22
Minimally Invasive Prostate Surgery Navigation System (K221499)Augment Intelligent Medical System (China) Co., Ltd.2022-11-22
Avenda Health AI Prostate Cancer Planning Software (K221624)Avenda Health, Inc.2022-11-22
SIS System (Version 5.6.0) (K223032)Surgical Information Sciences, Inc.2022-11-21
SM-V (K222951)Sedecal., Sa.2022-11-21
BriefCase (K221330)Aidoc Medical , Ltd.2022-11-18
EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG (K223124)DRTECH Corporation2022-11-18
SKR 3000 (K223267)Konica Minolta, Inc.2022-11-17
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