System, Image Processing, Radiological

FDA product code LLZ · 2150 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.2050
Review panel: RA
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1983-12-08 – 2026-09-23

LLZ 2018-07-19

DentiqGuide

Applicant 3D Industrial Imaging Co., Ltd.

K number K180629

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LLZ 2018-07-10

Ceevra Reveal 2.0

Applicant Ceevra, Inc.

K number K173274

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LLZ 2018-06-26

DenSeeMammo

Applicant Statlife

K number K173574

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LLZ 2018-06-22

MIM - SPECTRA Quant

Applicant Mim Software, Inc.

K number K180815

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LLZ 2018-06-19

sterEOS Workstation

Applicant Eos Imaging

K number K172346

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LLZ 2018-06-15

Fusion Bx 2.0

Applicant Focal Healthcare, Inc.

K number K181290

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LLZ 2018-06-14

EchoMD Automated Ejection Fraction Software

Applicant Bay Labs, Inc.

K number K173780

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LLZ 2018-06-07

QLAB Advanced Quantification Software

Applicant Philips Ultrasound, Inc.

K number K181264

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LLZ 2018-05-31

Interventional Workspot

Applicant Philips Medical Systems Nederland B.V.

K number K181177

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LLZ 2018-05-24

McKesson Cardiology

Applicant Change Healthcare Israel , Ltd.

K number K181080

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LLZ 2018-05-15

5D Viewer

Applicant Samsung Medison Co., Ltd.

K number K180883

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LLZ 2018-05-04

Invenia ABUS Viewer

Applicant GE Healthcare

K number K180641

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LLZ 2018-04-27

hipEOS

Applicant Onefit Medical

K number K173390

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LLZ 2018-04-25

syngo.plaza

Applicant Siemens Healthcare GmbH

K number K180563

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LLZ 2018-04-24

ZOOM

Applicant Zetta Medical Technologies, LLC

K number K172768

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LLZ 2018-04-20

Viz CTP

Applicant Viz. Ai, Inc.

K number K180161

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LLZ 2018-04-19

syngo.MR Applications

Applicant Siemens Medical Solutions USA, Inc.

K number K180336

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LLZ 2018-04-19

iSchemaView RAPID

Applicant Ischemaview, Inc.

K number K172477

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LLZ 2018-04-12

ZED Link

Applicant Zed Technologies

K number K180549

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LLZ 2018-04-05

PowerLook Density Assessment Software

Applicant Icad, Inc.

K number K180125

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LLZ 2018-04-05

syngo.via MI Workflows

Applicant Siemens Medical Solutions USA, Inc.

K number K173897

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LLZ 2018-04-05

uWS-MI

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K number K172998

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LLZ 2018-04-05

Corin Optimized Positioning System (OPS™) Plan

Applicant Corin U.S.A. Limited

K number K171847

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LLZ 2018-04-04

Scenium VE20 Software

Applicant Siemens Medical Solutions USA, Inc.

K number K173597

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LLZ 2018-04-04

SIMPLANT 18

Applicant Dentsply Sirona

K number K172239

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LLZ 2018-03-30

Vitrea Software Package; VSTP-001A

Applicant Canon Medical Systems Corporation

K number K180323

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LLZ 2018-03-23

MED-TAB

Applicant Plum Medical Solutions GmbH

K number K173241

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LLZ 2018-03-21

Emprint Ablation Visualization Application

Applicant Covidien, LLC

K number K180192

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LLZ 2018-03-21

Mimics inPrint

Applicant Materialise NV

K number K173619

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LLZ 2018-03-21

WillCeph

Applicant Hdx Will Corp.

K number K172168

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LLZ 2018-03-16

Imbio Segmentation Editing Tool software

Applicant Imbio, LLC

K number K180129

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LLZ 2018-03-16

syngo Application Software

Applicant Siemens Medical Solutions USA, Inc.

K number K173611

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LLZ 2018-03-12

SICAT Endo

Applicant Sicat GmbH & Co. KG

K number K180262

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LLZ 2018-03-09

BrightMatter Plan 1.6.0

Applicant Synaptive Medical, Inc.

K number K180394

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LLZ 2018-03-09

Quantib Brain

Applicant Quantib B.V.

K number K173939

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LLZ 2018-03-08

icobrain

Applicant Icometrix

K number K180326

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LLZ 2018-03-08

iQMR

Applicant Medic Vision - Imaging Solutions, Ltd.

K number K173605

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LLZ 2018-03-02

ProBx Software

Applicant Harmonus, Inc.

K number K173312

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LLZ 2018-02-28

CereMetrix Silver

Applicant Ceremetrix Corp

K number K173145

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LLZ 2018-02-23

Ez3D-i /E3

Applicant Ewoosoft Co., Ltd.

K number K173863

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LLZ 2018-02-23

DM-Density

Applicant Densitas, Inc.

K number K170540

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LLZ 2018-02-15

Velocity

Applicant Varian Medical Systems, Inc.

K number K173636

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LLZ 2018-02-12

SuRgical Planner (SRP)

Applicant Surgical Theater, LLC

K number K170793

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LLZ 2018-02-08

UNiD Spine Analyzer

Applicant Medicrea International

K number K180091

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LLZ 2018-02-08

SENYINT Remote Consultation System

Applicant Dalian Senyint Digital Medical System Co., Ltd.

K number K162727

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LLZ 2018-02-06

Insight BD

Applicant Siemens Medi Cal Solutions, Inc.

K number K172832

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LLZ 2018-02-06

eUnity

Applicant Client Outlook, Inc.

K number K172490

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LLZ 2018-02-05

MFI-Cardiac

Applicant Multifunctional Imaging, LLC

K number K173512

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LLZ 2018-01-31

Vitrea Software Toshiba Package VSTP-001A

Applicant Toshibamedical Systems Corporation

K number K173088

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LLZ 2018-01-25

Arterys Oncology DL

Applicant Arterys, Inc.

K number K173542

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LLZ 2018-01-16

CS Imaging

Applicant Trophy

K number K173622

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LLZ 2018-01-16

Navigo Workstation Version 2.0

Applicant UC-CARE , Ltd.

K number K173054

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LLZ 2018-01-12

Illumeo System

Applicant Philips Medical Systems Technologies , Ltd.

K number K173588

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LLZ 2018-01-11

DTX Studio diagnose

Applicant Nobel Biocare AB

K number K172224

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LLZ 2018-01-08

cNeuro cMRI

Applicant Combinostics OY

K number K171328

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LLZ 2018-01-05

ViewPoint 6

Applicant Ge Medical Systems Ultrasound and Primary

K number K173456

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LLZ 2017-12-27

Radiomics App v1.0

Applicant Microsoft Corp.

K number K173420

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LLZ 2017-12-12

Advanced Diffusion Analysis (ADA) application

Applicant Philips Medical Systems Nederland B.V.

K number K173467

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LLZ 2017-12-08

Merge PACS

Applicant Merge Healthcare Incorporated

K number K173475

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LLZ 2017-11-21

MIM – Y90 Dosimetry

Applicant Mim Software, Inc.

K number K172218

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LLZ 2017-11-20

syngo®.via protoNeo (Version VA20)

Applicant Siemens Healthcare GmbH

K number K173378

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LLZ 2017-11-15

jFit Surgical Planner

Applicant Jointvue, LLC

K number K173329

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LLZ 2017-11-14

Planmeca Romexis

Applicant Planmeca Oy

K number K171385

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LLZ 2017-11-08

Surgical Planning Software version 1.1

Applicant Ortho Kinematics, Inc.

K number K173247

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LLZ 2017-10-27

Infinitt PACS 7.0

Applicant Infinitt Healthcare Co., Ltd.

K number K172803

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LLZ 2017-10-26

OrthoVision

Applicant Ewoosoft Co., Ltd.

K number K173094

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LLZ 2017-10-20

BR-FHUS Viewer 1.0

Applicant Taihao Medical, Inc.

K number K171709

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LLZ 2017-10-20

Quantra

Applicant Hologic, Inc.

K number K163623

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LLZ 2017-10-18

Curve Image 2.0 PACS

Applicant Curve Dental, Ltd.

K number K173101

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LLZ 2017-10-18

OrthoView 7.2

Applicant Meridian Technique, Ltd.

K number K171068

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LLZ 2017-10-05

Vitrea Advanced Visualization, Version 7.6

Applicant Vital Images, Inc.

K number K172855

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LLZ 2017-09-29

ASPIRE Bellus II

Applicant Fujifilm Medical Systems U.S.A, Inc.

K number K171463

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LLZ 2017-09-26

Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM

Applicant Brainlab AG

K number K170816

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LLZ 2017-09-14

3D Echo

Applicant Jointvue, LLC

K number K172513

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LLZ 2017-09-07

NeuroQuant

Applicant Cortechs Labs, Inc.

K number K170981

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LLZ 2017-08-25

VMA™ System version 3.0

Applicant Ortho Kinematics, Inc.

K number K172327

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LLZ 2017-08-22

EzDent-i / E2 / Prora View

Applicant Ewoosoft Co., Ltd.

K number K172364

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LLZ 2017-08-22

OKI Surgical Planning Software

Applicant Ortho Kinematics, Inc.

K number K171617

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LLZ 2017-08-03

Clarity Reveal

Applicant Ceevra, Inc.

K number K171356

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LLZ 2017-07-28

NovaPACS

Applicant Novarad Corporation

K number K171754

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LLZ 2017-07-28

Smart Stitching Software System, Image Processing, Radiological

Applicant Osko, Inc.

K number K163048

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LLZ 2017-07-26

BiopSee, Mobile US

Applicant Medcom GmbH

K number K170841

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LLZ 2017-07-21

Vitrea View

Applicant Vital Images, Inc.

K number K163232

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LLZ 2017-07-18

Arterys Viewer

Applicant Arterys, Inc.

K number K171544

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LLZ 2017-07-18

Examion X-AQS

Applicant Examion GmbH

K number K170729

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LLZ 2017-07-17

3D Endo Software

Applicant Dentsply Sirona

K number K171115

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LLZ 2017-07-03

Enterprise Imaging XERO Viewer 8.1

Applicant Agfa Healthcare N.V.

K number K170434

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LLZ 2017-06-23

SUITESTENSA

Applicant Ebit Srl

K number K163668

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LLZ 2017-06-14

EchoPAC Software Only, EchoPAC Plug-in

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K number K170847

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LLZ 2017-06-09

syngo Application Software

Applicant Siemens Medical Solutions USA, Inc.

K number K170747

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LLZ 2017-06-08

Vitrea Software Toshiba Package; VSTP-001A

Applicant Toshibamedical Systems Corporation

K number K171222

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LLZ 2017-06-07

SmartTarget

Applicant Smarttarget, Ltd.

K number K170250

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LLZ 2017-06-01

syngo Dynamics Version VA30

Applicant Siemens Healthcare GmbH

K number K171053

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LLZ 2017-05-30

QLAB Advanced Quantification Software

Applicant Philips Health Care

K number K171314

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LLZ 2017-05-30

AmCAD-US

Applicant Amcad Biomed Corporation

K number K162574

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LLZ 2017-05-24

UNiD Spine Analyzer

Applicant Medicrea International

K number K170172

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LLZ 2017-05-24

vascuCAP

Applicant Elucid Bioimaging, Inc.

K number K163071

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LLZ 2017-05-17

QuantX

Applicant Quantitative Insights, Inc.

K number K170195

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LLZ 2017-05-17

Dynamika

Applicant Image Analysis Limited

K number K161601

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LLZ 2017-05-11

SurgiCase Viewer

Applicant Materialise NV

K number K170419

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