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 2020-12-04

HealthJOINT

Applicant Zebra Medical Vision, Ltd.

K number K202487

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LLZ 2020-12-02

Planmeca Romexis

Applicant Planmeca Oy

K number K200572

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LLZ 2020-11-20

DTX Studio Clinic

Applicant Nobel Biocare AB

K number K203156

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LLZ 2020-11-20

Optimized Positioning System (OPS) Insight

Applicant Corin USA

K number K202805

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LLZ 2020-11-20

CorInsights MRI

Applicant Adm Diagnostics, Inc.

K number K193287

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LLZ 2020-11-18

DBSWIN, VISTAEASY

Applicant Dürr Dental SE

K number K203287

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LLZ 2020-11-17

PROView

Applicant GE Medical Systems SCS

K number K193306

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LLZ 2020-11-06

Neuro.Al Algorithm

Applicant Terarecon,Inc.

K number K200750

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LLZ 2020-11-04

MyHip Planner & Verifier

Applicant Medacta International S.A.

K number K200350

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LLZ 2020-10-29

CloudVue

Applicant International Medical Solutions, Inc.

K number K203058

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LLZ 2020-10-27

OrthoNext Platform System

Applicant Orthofix Srl

K number K202519

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LLZ 2020-10-22

EzOrtho

Applicant Ewoosoft Co., Ltd.

K number K202948

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LLZ 2020-10-16

A View LCS

Applicant Coreline Soft Co., Ltd.

K number K201710

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LLZ 2020-10-11

Quantib Prostate

Applicant Quantib B.V.

K number K202501

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LLZ 2020-10-08

IPS CaseDesigner

Applicant Nobel Biocare AB

K number K200810

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LLZ 2020-10-05

UDE

Applicant Ebm Technologies, Inc.

K number K202292

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LLZ 2020-10-02

Cleerly Labs v2.0

Applicant Cleerly, Inc.

K number K202280

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LLZ 2020-09-30

e-Ortho Shoulder Software

Applicant FH Industrie

K number K201928

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LLZ 2020-09-30

THINQ

Applicant Corticometrics, LLC

K number K192051

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LLZ 2020-09-25

Xeleris V Processing and Review Systems

Applicant GE Healthcare

K number K201103

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LLZ 2020-09-20

AAA Model

Applicant Philips Ultrasound, Inc.

K number K200603

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LLZ 2020-09-18

EchoPAC Software Only, EchoPAC Plug-In

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K number K200852

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LLZ 2020-09-18

SentEP

Applicant Sentiar, Inc.

K number K192890

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LLZ 2020-09-16

AVA (Augmented Vascular Analysis)

Applicant See-Mode Technologies Pte, Ltd.

K number K201369

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LLZ 2020-09-15

Collaboration Live

Applicant Philips Ultrasound, Inc.

K number K201665

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LLZ 2020-09-11

Aline Ablation Intelligence

Applicant Mirada Medical, Ltd.

K number K202297

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LLZ 2020-09-09

3Shape Implant Studio

Applicant 3Shape Medical A/S

K number K202256

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LLZ 2020-09-09

AcroDTI Visualizer

Applicant Acroviz, Inc.

K number K201948

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LLZ 2020-09-04

Ambra ProViewer

Applicant Dicom Grid Inc Dba Ambra Health

K number K202335

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LLZ 2020-08-27

Synapse 3D Cardiac Tools

Applicant Fujifilm Corporaton

K number K200973

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LLZ 2020-08-26

AVIEW

Applicant Coreline Soft Co., Ltd.

K number K200714

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LLZ 2020-08-21

EzDent-i/ E2/ Prora View/ Smart M Viewer

Applicant Ewoosoft Co., Ltd.

K number K202116

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LLZ 2020-08-17

3D Auto LAA

Applicant Philips Health Care

K number K201352

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LLZ 2020-08-14

TOMTEC-ARENA

Applicant Tomtec Imaging Systems GmbH

K number K201632

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LLZ 2020-08-13

Limbus Contour

Applicant Limbus Ai, Inc.

K number K201232

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LLZ 2020-08-13

Braid

Applicant Braid.Health

K number K200822

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LLZ 2020-07-17

SuRgical Planner (SRP) BrainStorm

Applicant Surgical Theater, Inc.

K number K201465

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LLZ 2020-07-17

True 3D Viewer

Applicant Echopixel, Inc.

K number K201365

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LLZ 2020-07-10

AI-Rad Companion Engine

Applicant Siemens Medical Solutions USA, Inc.

K number K193294

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LLZ 2020-07-09

i-Rapha Solution

Applicant Irm, Inc.

K number K201296

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LLZ 2020-07-01

syngo.via View&GO

Applicant Siemens Healthcare GmbH

K number K201477

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LLZ 2020-06-26

Optimized Positioning System (OPS) ReView

Applicant Corin USA

K number K193042

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LLZ 2020-06-17

AI-Rad Companion Brain MR

Applicant Siemens Medical Solutions USA, Inc.

K number K193290

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LLZ 2020-06-15

Quantib AI Node

Applicant Quantib B.V.

K number K200899

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LLZ 2020-06-11

uWS-MI

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K number K192630

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LLZ 2020-06-02

MI View&GO

Applicant Siemens Medical Solutions USA, Inc.

K number K201202

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LLZ 2020-05-28

Brainomix 360 e-CTA

Applicant Brainomix Limited

K number K192692

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LLZ 2020-05-21

CariCloud

Applicant Caristo Diagnostics

K number K200274

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LLZ 2020-05-18

syngo Ultrasound Apps Suite (sUSAS)

Applicant Siemens Medical Solutions USA, Inc.

K number K201062

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LLZ 2020-05-05

ZeeroMED View

Applicant O3 Enterprise Srl

K number K200546

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LLZ 2020-05-05

Ziostation2

Applicant Ziosoft, Inc.

K number K200315

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LLZ 2020-05-05

AVIEW LCS

Applicant Coreline Soft Co., Ltd.

K number K193220

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LLZ 2020-05-01

Optimized Positioning System (OPS) Insight

Applicant Corin USA

K number K192656

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LLZ 2020-04-30

ArthrexVIP Web Portal

Applicant Arthrex, Inc.

K number K193523

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LLZ 2020-04-23

NemoFAB

Applicant Software Nemotec S.L.

K number K192475

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LLZ 2020-04-14

JiveX

Applicant Visus Health IT GmbH

K number K200703

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LLZ 2020-04-14

Xelis Dental 2.0

Applicant Infinitt Healthcare Co., Ltd.

K number K193369

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LLZ 2020-04-10

VARO Plan

Applicant 3D Industrial Imaging Co., Ltd.

K number K200078

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LLZ 2020-04-09

EchoNavigator

Applicant Philips Medical Systems Nederland B.V.

K number K200713

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LLZ 2020-04-02

IntelePACS

Applicant Intelerad Medical Systems Incorporated

K number K192176

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LLZ 2020-03-16

AnatomicAligner

Applicant The Methodist Hospital Research Institute D/B/A Houston

K number K190767

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LLZ 2020-03-13

EzOrtho

Applicant Ewoosoft Co., Ltd.

K number K192888

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LLZ 2020-03-05

Kinepict Medical Imaging Tool version v2.2

Applicant Kinepict Health, Ltd.

K number K190993

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LLZ 2020-02-28

icobrain-ctp

Applicant Icometrix NV

K number K192962

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LLZ 2020-02-25

Ez3D-i /E3

Applicant Ewoosoft Co., Ltd.

K number K200178

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LLZ 2020-02-19

densitas densityai

Applicant Densitas, Inc.

K number K192973

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LLZ 2020-02-18

Collaboration Live

Applicant Philips Health Care

K number K200179

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LLZ 2020-02-18

Ashvins

Applicant Medicalcommunications GmbH

K number K200132

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LLZ 2020-02-14

Vitrea Software Package

Applicant Canon Medical Systems Corporation

K number K192923

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LLZ 2020-02-14

ASCEND Image Viewer

Applicant Ascend Hit

K number K192372

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LLZ 2020-02-13

Infinitt RT PACS

Applicant Infinitt Healthcare Co., Ltd.

K number K193498

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LLZ 2020-02-11

Acteon Imaging Suite

Applicant De Gotzen S.R.L.

K number K192165

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LLZ 2020-01-31

syngo.MR Applications

Applicant Siemens Medical Solutions USA, Inc.

K number K192462

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LLZ 2020-01-24

FlightPlan for Embolization

Applicant GE Medical Systems SCS

K number K193261

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LLZ 2020-01-23

Elements Viewer

Applicant Brainlab AG

K number K191014

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LLZ 2020-01-20

EzMobile

Applicant Ewoosoft Co., Ltd.

K number K192098

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LLZ 2020-01-15

ADAS 3D

Applicant Galgo Medical S.L

K number K191125

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LLZ 2020-01-06

ViewPoint 6

Applicant Ge Medical Systems Ultrasound And

K number K192917

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LLZ 2019-12-31

AutoMIStar

Applicant Apollo Medical Imaging Technology Pty. , Ltd.

K number K192912

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LLZ 2019-12-27

UroNav System

Applicant Invivo Corporation

K number K193403

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LLZ 2019-12-27

True 3D Viewer Software

Applicant Echopixel, Inc.

K number K193149

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LLZ 2019-12-20

AVIEW Modeler

Applicant Coreline Soft Co., Ltd.

K number K192040

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LLZ 2019-12-19

DentiqAir

Applicant 3D Industrial Imaging Co., Ltd.

K number K183676

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LLZ 2019-12-13

QyScore Software

Applicant Qynapse

K number K192531

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LLZ 2019-12-13

Icobrain

Applicant Icometrix NV

K number K192130

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LLZ 2019-12-11

NemoScan

Applicant Software Nemotec S.L.

K number K192571

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LLZ 2019-12-07

PhantomMSK Trauma

Applicant OrthoGrid Systems, Inc.

K number K192279

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LLZ 2019-12-04

SICAT Implant V2.0

Applicant Sicat GmbH & Co. KG

K number K192348

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LLZ 2019-12-02

Emprint Visualization Application

Applicant Covidien, LLC

K number K192038

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LLZ 2019-11-22

Medsynapse Ris Pacs & Medsynapse VNA

Applicant Medsynaptic Private, Ltd.

K number K192508

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LLZ 2019-11-19

RSI-MRI+

Applicant Multimodal Imaging Services Corporation (Dba Healthlytix)

K number K191278

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LLZ 2019-11-08

QuantX Breast MRI Biopsy Guidance Plugin

Applicant Qlarity Imaging

K number K191959

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LLZ 2019-11-07

MEDIP PRO

Applicant Medical IP Co., Ltd.

K number K191026

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LLZ 2019-11-05

KOALA

Applicant Ib Lab GmbH

K number K192109

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LLZ 2019-11-05

Cleerly Labs

Applicant Cleerly, Inc.

K number K190868

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LLZ 2019-10-31

VisionX 2.4

Applicant Durr Dental SE

K number K192743

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LLZ 2019-10-31

mediCAD Web

Applicant Medicad Hectec GmbH

K number K183412

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LLZ 2019-10-18

Synapse 3D Blood Flow Analysis

Applicant Fujifilm Corporation

K number K191544

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LLZ 2019-10-17

Merge PACS

Applicant Merge Healthcare Incorporated

K number K192455

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LLZ 2019-10-17

Voxel Dosimetry™ v1.0

Applicant Hermes Medical Solutions AB

K number K191216

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