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 2019-10-17

SmartCeph

Applicant Ortho2, LLC

K number K190162

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LLZ 2019-10-16

Ventripoint Medical System Plus (VMS+) 3.0

Applicant Ventripoint Diagnostics , Ltd.

K number K191493

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LLZ 2019-10-09

DynaCAD

Applicant Invivo Corporation

K number K192200

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LLZ 2019-10-01

RTapp

Applicant Segana, LLC

K number K191610

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LLZ 2019-09-26

NuVasive NuvaLine

Applicant Nu Vasive, Incorporated

K number K192435

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LLZ 2019-09-26

StoneChecker

Applicant Imaging Biometrics, LLC

K number K191530

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LLZ 2019-09-20

Merge Cardio

Applicant Merge Healthcare Incorporated

K number K192276

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LLZ 2019-09-16

SubtleMR

Applicant Subtle Medical, Inc.

K number K191688

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LLZ 2019-09-13

SIS Software Version 3.6.0

Applicant Surgical Information Sciences, Inc.

K number K192304

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LLZ 2019-09-12

syngo Application Software

Applicant Siemens Medical Solution USA, Inc.

K number K190780

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LLZ 2019-08-29

D2P

Applicant 3D Systems, Inc.

K number K183489

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LLZ 2019-08-23

Efficient Care 3D Planning

Applicant Orthosoft Inc (D/B/A Zimmer Cas)

K number K183544

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LLZ 2019-08-06

exoplan 2.3

Applicant Exocad GmbH

K number K183458

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LLZ 2019-08-05

aBSI

Applicant Exini Diagnostics AB

K number K191262

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LLZ 2019-08-01

MREplus+ Software

Applicant Resoundant, Inc.

K number K183193

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LLZ 2019-07-19

syngo.via MI Workflows VB40A, Scenium

Applicant Siemens Medical Soultions USA, Inc.

K number K191309

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LLZ 2019-07-12

iNtuition-Structural Heart Module

Applicant Terarecon,Inc.

K number K191585

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LLZ 2019-07-11

Unifi Workspace v1.0.0

Applicant Hologic, Inc.

K number K190694

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LLZ 2019-07-05

syngo.MR Applications

Applicant Siemens Medical Solutions USA, Inc.

K number K182904

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LLZ 2019-06-26

R2GATE

Applicant Megagen Implant Co., Ltd.

K number K190096

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LLZ 2019-06-24

uWS-CT

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K number K183170

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LLZ 2019-06-18

QLAB Advanced Quantification Software 13

Applicant Philips Health Care

K number K190913

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LLZ 2019-06-13

ClariCT.AI

Applicant Claripi, Inc.

K number K183460

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LLZ 2019-06-05

Materialise Mimics Enlight

Applicant Materialise NV

K number K190874

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LLZ 2019-05-30

ASHK100G

Applicant Lg Electronics

K number K191188

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LLZ 2019-05-16

syngo.via (Version VB40A)

Applicant Siemens Healthcare GmbH

K number K191040

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LLZ 2019-05-13

SurgicalAR

Applicant Medivis, Inc.

K number K190764

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LLZ 2019-04-30

XmaruView V1 (Xmaru Chiroview, Xmaru Podview)

Applicant Rayence Co., Ltd.

K number K190866

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LLZ 2019-04-25

Brainlab Elements Image Fusion Angio

Applicant Brainlab AG

K number K190042

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LLZ 2019-04-25

Synapse Enterprise Viewer Version 1.0

Applicant Fujifilm Corporation

K number K183248

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LLZ 2019-04-19

Ez3D-i/E3

Applicant Ewoosoft Co., Ltd.

K number K190791

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LLZ 2019-04-18

Lung Vision System

Applicant Bodyvision Medical , Ltd.

K number K183593

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LLZ 2019-04-15

NDOHD High Definition Imaging System (NDOHD)

Applicant Altaravision, Inc.

K number K190420

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LLZ 2019-04-12

InstaRISPACS / InstaZFP / InstaMobi v5.0

Applicant Meddiff Technologies Pvt. , Ltd.

K number K182572

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LLZ 2019-04-01

DBSWIN and VISTAEASY Imaging Software

Applicant Durr Dental SE

K number K190629

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LLZ 2019-03-29

Thoracic VCAR with GSI Pulmonary Perfusion

Applicant GE Medical Systems SCS

K number K183210

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LLZ 2019-03-27

Mimics Medical

Applicant Materialise NV

K number K183105

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LLZ 2019-03-26

Synapse PACS

Applicant Fujifilm Corporation

K number K190232

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LLZ 2019-03-22

uWS-MR

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K number K183164

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LLZ 2019-03-19

MIM on Linux

Applicant Mim Software, Inc.

K number K190379

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LLZ 2019-03-19

SIS Software version 3.3.0

Applicant Surgical Information Sciences, Inc.

K number K183019

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LLZ 2019-03-08

RADMAX Digital Imaging Software

Applicant DRGEM Corporation

K number K182537

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LLZ 2019-03-06

PLANET Onco Dose

Applicant Dosisoft

K number K182966

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LLZ 2019-03-06

Visualase Thermal Therapy System

Applicant Medtronic Navigation, Inc.

K number K181859

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LLZ 2019-03-01

ClearON Mobile

Applicant Rayence Co., Ltd.

K number K183478

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LLZ 2019-02-27

EzDent-i / E2 / Prora View

Applicant Ewoosoft Co., Ltd.

K number K190087

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LLZ 2019-02-22

IRIS 1.0 System

Applicant Intuitive Surgical

K number K182643

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LLZ 2019-02-15

PhantomMSK

Applicant OrthoGrid Systems, Inc.

K number K182332

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LLZ 2019-02-14

Presero 3D Scanning System

Applicant Certis Health

K number K190074

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LLZ 2019-02-01

AI Rad Companion (Engine)

Applicant Siemens Medical Solutions USA, Inc.

K number K183272

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LLZ 2019-01-09

MRCP+ v1.0

Applicant Perspectum Diagnostics, Ltd.

K number K183133

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LLZ 2019-01-02

ProKnow DS

Applicant Proknow, LLC

K number K182855

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LLZ 2018-12-28

AmCAD-UO

Applicant Amcad Biomed Corporation

K number K180867

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LLZ 2018-12-27

Quantib ND

Applicant Quantib B.V.

K number K182564

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LLZ 2018-12-27

iSchemaView RAPID

Applicant Ischemaview, Inc.

K number K182130

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LLZ 2018-12-21

vascuCAP

Applicant Elucid Bioimaging, Inc.

K number K183012

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LLZ 2018-12-21

4D View

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K number K182750

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LLZ 2018-12-20

3DIEMME RealGUIDE

Applicant 3Diemme , Ltd.

K number K173041

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LLZ 2018-12-18

MIM - MRT Dosimetry

Applicant Mim Software, Inc.

K number K182624

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LLZ 2018-12-14

Vitrea Software Package, VSTP-001A

Applicant Canon Medical Systems Corporation

K number K182601

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LLZ 2018-12-14

Centricity Universal Viewer

Applicant GE Healthcare

K number K182419

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LLZ 2018-12-13

HipCheck

Applicant Stryker Corp.

K number K182359

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LLZ 2018-12-06

IntelliSpace Radiology

Applicant Philips Healthcare Informatics, Inc.

K number K182926

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LLZ 2018-12-06

Simplicit90Y

Applicant Mirada Medical, Ltd.

K number K182016

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LLZ 2018-12-04

CAAS MR Solutions

Applicant Pie Medical Imaging BV

K number K181825

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LLZ 2018-12-03

IMPLANTER DENTAL PLANNING SOFTWARE

Applicant Implanter, LLC

K number K173083

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LLZ 2018-11-30

XVWeb 3D

Applicant Apteryx, Inc.

K number K182815

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LLZ 2018-11-26

Corin Optimized Positioning System (OPS) Plan

Applicant Corin USA

K number K183038

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LLZ 2018-11-26

Vitrea Software Package, VSTP-001A

Applicant Canon Medical Systems Corporation

K number K183013

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LLZ 2018-11-26

Konicaminolta DI-X1

Applicant Konica Minolta, Inc.

K number K182431

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LLZ 2018-11-21

ProFuse CAD

Applicant Eigen

K number K173744

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LLZ 2018-11-20

Vitrea CT Brain Perfusion

Applicant Vital Images, Inc.

K number K181247

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LLZ 2018-11-07

uWS-CT

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K number K173001

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LLZ 2018-11-07

uWS-MR

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K number K172999

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LLZ 2018-11-06

icobrain

Applicant Icometrix NV

K number K181939

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LLZ 2018-10-31

AVIEW

Applicant Coreline Soft Co., Ltd.

K number K171199

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LLZ 2018-10-26

Implant Planning Software

Applicant Inteware Co., Ltd.

K number K173965

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LLZ 2018-10-25

PeekMed

Applicant Peek Health, S.A.

K number K182464

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LLZ 2018-10-23

JiveX

Applicant Visus Health IT GmbH

K number K181964

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LLZ 2018-10-19

UroNav (Version 3.0)

Applicant Invivo Corporation

K number K182561

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LLZ 2018-10-17

Arterys MICA

Applicant Arterys, Inc.

K number K182034

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LLZ 2018-10-11

OnePacs System

Applicant Onepacs, LLC

K number K181460

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LLZ 2018-10-09

Ziostation2

Applicant Ziosoft, Inc.

K number K181892

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LLZ 2018-09-25

IBM iConnect Access

Applicant Merge Healthcare Incorporated

K number K182290

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LLZ 2018-09-25

Synapse 3D Optional Tools

Applicant Fujifilm Corporation

K number K181773

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LLZ 2018-09-24

iNtuition-T1 Mapping and T2/T2* Mapping

Applicant Terarecon,Inc.

K number K180916

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LLZ 2018-09-21

Volpara Imaging Software

Applicant Volpara Health Technologies Limited

K number K182310

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LLZ 2018-09-21

InVivo Web Viewer

Applicant Anatomage, Inc.

K number K181926

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LLZ 2018-09-21

OpenSight

Applicant Novarad Corporation

K number K172418

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LLZ 2018-09-07

Multi Modality Viewer

Applicant Vital Images, Inc.

K number K182230

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LLZ 2018-09-07

syngo.via View&GO (Version VA10A)

Applicant Siemens Healthcare GmbH

K number K182208

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LLZ 2018-09-07

mediCAD 4.0

Applicant Medicad Hectec GmbH

K number K170702

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LLZ 2018-08-31

AmCAD-UT Detection 2.2

Applicant Amcad Biomed Corporation

K number K180006

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LLZ 2018-08-29

Change Healthcare Enterprise Viewer

Applicant Change Healthcare Canada Company

K number K181185

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LLZ 2018-08-16

IGTFusion

Applicant Igi Technologies

K number K180522

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LLZ 2018-08-13

ONIS-PACS

Applicant Digitalcore Co., Ltd.

K number K181318

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LLZ 2018-08-07

CubeVue

Applicant Curvebeam, LLC

K number K181962

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LLZ 2018-08-03

VirtuOst Vertebral Fracture Assessment

Applicant O.N. Diagnostics, LLC

K number K171435

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LLZ 2018-08-02

miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer

Applicant Hinacom Software and Technology, Ltd.

K number K171977

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LLZ 2018-07-23

Quantitative Total Extensible Imaging (QTxI)

Applicant Aiq Solutions, Inc.

K number K173444

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