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Ablation Catheter Surgical Imaging Diagnostic All medical devices

All classes Class I Class II Class III100 entries · live · openFDA

510(k)

Sponsor

Device

Class

Cleared

Intuitive Surgical

da Vinci Firefly Imaging System

Surgimage Corporation

SURGIMAGE SIM 1000H Fluorescence Imaging Platform

OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)

Overjet Iris Intelligent Imaging System

Anhui Happiness Workshop Instruments Co., Ltd.

Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)

Boston Scientific

OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)

Medical Imaging Calibration Feature (MICF)

Good Methods Global, Inc.

Mars Bioimaging , Ltd.

Extremity CT Imaging System

Canon Medical Systems Corporation

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)

Karl Storz SE & CO. KG

KARL STORZ ICG Imaging System with RUBINA® Lens

Stryker Endoscopy

1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality

Balmoral Medical, LLC

ROSA Knee System with UltraSound Imaging Platform (USIP)

Eyas Medical Imaging, Inc.

Ascent3T Neonatal Magnetic Resonance Imaging System

Spectrawave, Inc.

HyperVue Imaging System - Integrated

Hyperfine, Inc.

Swoop® Portable MR Imaging® System

Asustek Computer, Inc.

ASUS Ultrasound Imaging System (LU800 series)

Dendrite Imaging, Inc.

Dendrite Imaging System

Archy Dental, Inc.

Archy Dental Imaging

Sirona Advanced Imaging Suite

Inkspace Imaging, Inc.

InkSpace Imaging Small Body Array (SBA12PH30x)

Arthrex Synergy Vision Imaging System

Agfa Healthcare N.V.

AGFA HealthCare Enterprise Imaging

Canon Medical Systems Corporation

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging

Digital X-Ray DentiMax Pro Imaging System

Diagnostic Green GmbH

IC-Flow Imaging System 2.0

Intuitive Surgical, Inc.

da Vinci SP Firefly Imaging System

Shen Zhen Cambridge-Hit Co., Ltd.

Digital Radiographic Imaging Acquisition Software - DR (RiasDR)

Wuxi Hisky Medical Technologies Co., Ltd.

Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580);

Dxtx Medical, Inc.

e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector

Terumo Cardiovascular Systems Thi Plant

OPUSWAVE Dual Sensor Imaging System

Hyperfine, Inc.

Swoop® Portable MR Imaging® System (V2)

Hyperfine, Inc.

Swoop® Portable MR Imaging® System

Medicatech USA, Inc.

MasteRad MiniX Mobile Digital Imaging System (Mini-X)

Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series)

Arthrex Synergy Vision Endoscopic Imaging System

Fluoptics Sas (A Getinge Group Company}

FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)

Shenzhen Vivolight Medical Device & Technology Co., Ltd.

Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)

Hi-D Imaging AG

Hi-D Imaging 4TAVR

Shantou Institute of Ultrasonic Instruments Co., Ltd.

Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler Ultrasound Imaging System (Apogee C2); Digital Color Doppler Ultrasound Imaging System (Apogee C3); Digital Color Doppler Ultrasound Imaging System (Apogee C5); Digital Color Doppler Ultrasound Imaging System (Apogee K1); Digital Color Doppler Ultrasound Imaging System (Apogee K2); Digital Color Doppler Ultrasound Imaging System (Apogee K3); Digital Color Doppler Ultrasound Imaging System (Apogee K5); Di

ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)

Luma Vision Limited

VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System

Spectrawave, Inc.

Starlight Imaging Catheter

Radlink GPS Pro Imaging

Shenzhen Sanping Image Technology Co., Ltd.

Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1)

Infraredx, Inc.

Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )

Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter

Raysolution Healthcare Co., Ltd.

Imaging system of positron emission and X-ray computed tomography (DigitMI 930)

Jiangsu Lici Medical Device Co., Ltd.

NIDO Baby Magnetic Resonance Imaging System

Inkspace Imaging, Inc.

InkSpace Imaging Small Body Array

Shantou Institute of Ultrasonic Instruments Co., Ltd.

Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6)

Change Healthcare Canada Company

Change Healthcare Stratus Imaging PACS

Guangdong Optomedic Technologies, Inc.

FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)

Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging

HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))

Guangdong Optomedic Technologies, Inc.

Stellar Imaging System

Arthrex Synergy Vision Endoscopic Imaging System

Hyperfine, Inc.

Swoop® Portable MR Imaging® System

SC1 Handheld Ultrasound Imaging system (Model: SC1)

Medtronic Navigation, Inc.

O-arm O2 Imaging System

Schoelly Fiberoptic GmbH

SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)

Rwd Life Science Co., Ltd.

Laser Speckle Imaging System (RFLSI CZW)

Guangdong Youkey Medical Co., Ltd.

Digital Ultrasonic Diagnostic Imaging System (Model: F6)

Stryker Endoscopy

1688 4K Camera System with Advanced Imaging Modality

Arthrex Synergy Vision Endoscopic Imaging System

Stryker Endoscopy

1788 4K Camera System with Advanced Imaging Modality

Inkspace Imaging, Inc.

InkSpace Imaging Small Body Array

Fluoptics Sas (A Getinge Group Company)

FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)

Karl Storz SE & CO. KG

KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit

Karl Storz SE & CO. KG

KARL STORZ ICG Imaging System

K3900 Ultrasound Imaging System

Hyperfine, Inc.

Swoop® Portable MR Imaging System®

1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM

ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6

Convergent Imaging Solutions

UniSyn Molecular Imaging (6-3-1)

Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter

Activ Surgical, Inc.

ActivSight Intraoperative Imaging System

STERIS Corporation

Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101

Guangdong Optomedic Technologies, Inc.

FloNavi Open Field Fluorescence Imaging System

Acutus Medical, Inc.

AcQMap High Resolution Imaging and Mapping System

Spectrawave, Inc.

HyperVue Imaging System

Novadaq Technologies Ulc (A Part of Stryker)

SPY Portable Handheld Imaging (SPY-PHI) System

Boston Scientific Corporation

OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter

Acutus Medical, Inc.

AcQMap® High Resolution Imaging and Mapping System

Dragonfly OpStar Imaging Catheter

1788 4K Camera System with Advanced Imaging Modality

Spectrawave, Inc.

SpectraWAVE Imaging System

Arthrex SynergyID Endoscopic Imaging System

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)

Hyperfine, Inc.

Swoop® Portable MR Imaging System

Guangdong Optomedic Technologies, Inc.

FloNavi Endoscopic Fluorescence Imaging System

STERIS Corporation

Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101

Pausch Medical GmbH

Ortho Device, ADAPTIX 3D Orthopedic Imaging System

Circle Cardiovascular Imaging, Inc.

TruPlan Computed Tomography (CT) Imaging Software

Scivita Medical Technology Co., Ltd.

Scivita 4KINSIGHT ICG Imaging System

Inkspace Imaging, Inc.

InkSpace Imaging Body Array

Hyperfine, Inc.

Swoop Portable MR Imaging System

Pentax of America, Inc.

PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10

Imsonic Medical China, Inc.

ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System

Patterson Dental Supply, Inc.

Dolphin Blue Imaging

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