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 2017-05-11

Lung Vision

Applicant Bodyvision Medical , Ltd.

K number K163622

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LLZ 2017-05-11

Longitudinal Brain Imaging (LoBI) application

Applicant Philips Medical Systems Nederland B.V.

K number K163250

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LLZ 2017-05-08

Will3D

Applicant Hdx Will Corp.

K number K170180

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LLZ 2017-05-04

Nucleus Image Management System

Applicant Nucleushealth, LLC

K number K171130

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LLZ 2017-05-01

NaviSuite SSI Edition

Applicant Medcom GmbH

K number K163119

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LLZ 2017-05-01

NuVasive NuvaLine Mobile App

Applicant Nu Vasive, Incorporated

K number K162647

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LLZ 2017-04-28

syngo.CT View&GO

Applicant Siemens Medical Solutions USA, Inc.

K number K170952

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LLZ 2017-04-26

AmCAD-UV

Applicant Amcad Biomed Corporation

K number K170069

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LLZ 2017-04-25

Cliniview

Applicant Palodex Group OY

K number K162799

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LLZ 2017-04-11

Carestream Vue PACS

Applicant Carestream Health, Inc.

K number K170580

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LLZ 2017-04-06

Synapse 3D Perfusion Analysis

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

K number K162287

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LLZ 2017-04-05

Segment CMR

Applicant Medviso AB

K number K163076

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LLZ 2017-04-05

LIFESYS PACS

Applicant Lifetrack Medical Systems, Inc.

K number K161341

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LLZ 2017-03-31

Move Forward 3D Motion Simulation Service

Applicant Biomet, Inc.

K number K162559

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LLZ 2017-03-24

INFINITT ULite

Applicant Infinitt Co., Ltd.

K number K163290

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LLZ 2017-03-21

360KS Implant Positioning System

Applicant Kico Knee Innovation Company Pty Limited

K number K163405

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LLZ 2017-03-17

Exam Vue PACS

Applicant Jpi Healthcare Solutions, Inc.

K number K162868

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LLZ 2017-03-16

FDX Console (DR-ID300CL) Software

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

K number K170451

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LLZ 2017-03-03

True 3D Viewer Software

Applicant Echopixel, Inc.

K number K170167

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LLZ 2017-02-23

Lung Nodule Assessment and Comparison Option (LNA)

Applicant Philips Medical Systems Nederland B.V.

K number K162484

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LLZ 2017-02-14

syngo Application Software

Applicant Siemens Medical Solution USA, Inc.

K number K163285

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LLZ 2017-02-14

SIS Software

Applicant Surgical Information Sciences, Inc.

K number K162830

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LLZ 2017-02-06

syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology

Applicant Siemens Medical Solutions USA, Inc.

K number K163294

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LLZ 2017-02-06

UC-CARE NaviGo Workstation

Applicant UC-CARE , Ltd.

K number K160934

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LLZ 2017-01-31

NobelClinician, DTX Studio implant

Applicant Nobel Biocare AB

K number K163122

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LLZ 2017-01-27

nordicBrainEx

Applicant Nordicneurolab AS

K number K163324

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LLZ 2017-01-27

EBM iDO Viewer 1.2.1

Applicant Ebm Technologies Incorporated

K number K162285

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LLZ 2017-01-26

Multi Modality Viewer

Applicant Vital Images, Inc.

K number K163574

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LLZ 2017-01-12

EzDent-i; E2; ProraView

Applicant Ewoosoft Co., Ltd.

K number K163533

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LLZ 2017-01-09

D2P

Applicant 3D Systems, Inc.

K number K161841

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LLZ 2017-01-06

Quantib Brain 1.2

Applicant Quantib B.V.

K number K163013

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LLZ 2017-01-05

Arterys Cardio DL

Applicant Arterys, Inc.

K number K163253

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LLZ 2017-01-04

CephSimulation

Applicant Anatomage, Inc.

K number K161270

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LLZ 2017-01-03

syngo.via MI Workflows

Applicant Siemens Medical Solutions USA, Inc.

K number K163421

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LLZ 2016-12-28

ClearView cCAD

Applicant Clearview Diagnostics, Inc.

K number K161959

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LLZ 2016-12-23

Ez3D-i / E3

Applicant Ewoosoft Co., Ltd.

K number K163539

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LLZ 2016-12-19

Multi-Modality Tumor Tracking (MMTT) application

Applicant Philips Medical Systems Nederland B.V.

K number K162955

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LLZ 2016-12-15

Zia

Applicant Zetta Medical Technologies, LLC

K number K160852

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LLZ 2016-12-08

CAAS MR 4D Flow

Applicant Pie Medical Imaging BV

K number K162376

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LLZ 2016-12-07

CT CoPilot

Applicant Zepmed, LLC

K number K161322

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LLZ 2016-12-05

DENSEEMAMMO v1.0

Applicant Statlife

K number K152009

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LLZ 2016-12-02

MEDSYNAPSE Zero Footprint Viewer

Applicant Medsynaptic Private, Ltd.

K number K163158

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LLZ 2016-11-22

ViewPoint 6

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K number K162743

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LLZ 2016-11-16

syngo Application Software

Applicant Siemens Medical Solutions USA, Inc.

K number K162541

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LLZ 2016-11-15

eUnity

Applicant Client Outlook, Inc.

K number K161515

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LLZ 2016-11-10

IPS CaseDesigner

Applicant Nobel Biocare AB

K number K161634

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LLZ 2016-10-28

Arterys Software v2.0

Applicant Arterys, Inc.

K number K162513

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LLZ 2016-10-25

vRad PACS with Mammography

Applicant Virtual Radiologic Corporation

K number K162145

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LLZ 2016-10-21

Artemis

Applicant Eigen

K number K162474

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LLZ 2016-10-18

IntelliSpace Portal Platform

Applicant Philips Medical Systems Nederlands B.V.

K number K162025

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LLZ 2016-10-14

MedDream

Applicant Softneta Uab

K number K162011

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LLZ 2016-10-14

NovaPACS

Applicant Novarad Corporation

K number K160371

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LLZ 2016-10-06

iSR'obot MRI-US Fusion

Applicant Biobot Surgical Pte., Ltd.

K number K161109

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LLZ 2016-10-05

Dentiq3D

Applicant 3D Industrial Imaging Co., Ltd.

K number K160666

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LLZ 2016-10-03

kneeEOS

Applicant Onefit Medical

K number K161828

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LLZ 2016-09-21

Scenium

Applicant Siemens Medical Solutions USA, Inc.

K number K162339

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LLZ 2016-09-21

CAAS MRV

Applicant Pie Medical Imaging BV

K number K162112

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LLZ 2016-09-19

PixelShine

Applicant Algomedica

K number K161625

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LLZ 2016-09-16

JiveX

Applicant Visus Technology Transfer GmbH

K number K162008

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LLZ 2016-09-02

Restore PACS

Applicant Xian Wingspan Electronic Technology Co., Ltd.

K number K162141

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LLZ 2016-09-02

PROcedure Rehearsal Studio

Applicant 3Dsystems, Simbionix Products

K number K153705

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LLZ 2016-08-24

ResolutionMD

Applicant Calgary Scientific, Inc.

K number K161130

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LLZ 2016-08-17

PACS CORE/ENCORE

Applicant Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.

K number K161518

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LLZ 2016-08-17

WebPAX

Applicant Heart Imaging Technologies, LLC

K number K152949

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LLZ 2016-08-10

5D Viewer

Applicant Samsung Medison Co., Ltd.

K number K161955

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LLZ 2016-08-09

icobrain

Applicant Icometrix

K number K161148

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LLZ 2016-08-05

QXLink

Applicant Vieworks Co., Ltd.

K number K161113

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LLZ 2016-08-03

JointPoint

Applicant Jointpoint, Inc.

K number K160284

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LLZ 2016-08-01

Senolris

Applicant GE Healthcare

K number K160937

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LLZ 2016-07-28

LVivo Software Application

Applicant Diacardio, Ltd.

K number K161382

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LLZ 2016-07-28

SIMPLANT Online Case Review and SIMPLANT Editor

Applicant Dentsply Sirona

K number K161118

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LLZ 2016-07-13

Multi Modality Viewer

Applicant Vital Images, Inc.

K number K161419

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LLZ 2016-07-11

syngo®.via protoNeo (Version VA10A)

Applicant Siemens Healthcare GmbH

K number K161685

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LLZ 2016-06-28

hipEOS

Applicant Onefit Medical

K number K161479

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LLZ 2016-06-28

Surgical Navigation Advanced Platform (SNAP)

Applicant Surgical Theater, LLC

K number K160584

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LLZ 2016-06-23

Kuvia3D

Applicant 4qimaging, LLC Dba Qmetrics

K number K161559

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LLZ 2016-06-22

IMPAX Volume Viewing 4.0

Applicant Agfa Healthcare N.V.

K number K161061

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LLZ 2016-06-21

DBSWIN and VistaEasy Imaging Software

Applicant Duerr Dental AG

K number K161444

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LLZ 2016-06-21

Advanced Medical Imaging Software Suite (KSWVWR)

Applicant Keosys Sas

K number K160334

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LLZ 2016-06-17

Quantib Brain 1

Applicant Quantib B.V.

K number K153351

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LLZ 2016-06-09

HEPATIQ 1.1

Applicant Hepatiq, LLC

K number K161188

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LLZ 2016-05-31

Ez3D-i / E3

Applicant Ewoosoft Co., Ltd.

K number K161246

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LLZ 2016-05-27

3mensio Workstation

Applicant Pie Medical Imaging BV

K number K153736

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LLZ 2016-05-13

EzDent-i / E2 / Prora View

Applicant Ewoosoft Co., Ltd.

K number K161117

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LLZ 2016-04-25

MIM-Thin Client (mobile)

Applicant Mim Software, Inc.

K number K151913

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LLZ 2016-04-22

sterEOS Workstation

Applicant Eos Imaging, Inc.

K number K160914

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LLZ 2016-04-13

DICOM Viewer

Applicant Brainlab AG

K number K153653

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LLZ 2016-04-12

EndoSize

Applicant Therenva Sas

K number K160376

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LLZ 2016-04-08

Xmaru View V1 and Xmaru PACS, Medical Image Processing Software

Applicant Rayence Co., Ltd.

K number K160579

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LLZ 2016-04-08

spineEOS

Applicant Onefit Medical

K number K160407

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LLZ 2016-03-29

Synaptive ImageDrive Pro

Applicant Synaptive Medical, Inc.

K number K153284

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LLZ 2016-03-24

EV Insite System

Applicant Psp Corporation

K number K152716

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LLZ 2016-03-16

Vitrea CT Colon Analysis

Applicant Vital Images, Inc.

K number K160150

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LLZ 2016-03-16

Xeleris 4.0 Processing and Review Workstation

Applicant GE Healthcare

K number K153355

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LLZ 2016-03-15

ArthrexVIP Web Portal

Applicant Custom Orthopaedic Solutions, Inc.

K number K153612

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LLZ 2016-03-04

syngo.via MI Workflows

Applicant Siemens Medical Solutions USA, Inc.

K number K160426

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LLZ 2016-03-04

syngo Application Software VD11

Applicant Siemens Medical Solutions USA, Inc.

K number K153346

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LLZ 2016-03-03

Olea Sphere V3.0

Applicant Olea Medical

K number K152602

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LLZ 2016-02-29

syngo.via MI Workflows

Applicant Siemens Medical Solutions USA, Inc.

K number K160317

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LLZ 2016-02-25

IMPLANT 3D

Applicant Media Lab S.R.L.

K number K153091

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