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 2022-04-22

MirrorMe3D Modeling System

Applicant Mirrorme3D, LLC

K number K212981

View details →

LLZ 2022-04-15

XD

Applicant Mirada Medical, Ltd.

K number K220779

View details →

LLZ 2022-04-14

TeleScan

Applicant Bb Imaging

K number K220767

View details →

LLZ 2022-04-06

ClariPulmo

Applicant Claripi, Inc.

K number K203783

View details →

LLZ 2022-03-25

DTX Studio Clinic 3.0

Applicant Nobel Biocare AB

K number K213562

View details →

LLZ 2022-03-11

RI.HIP MODELER

Applicant Blue Belt Technologies, Inc.

K number K212040

View details →

LLZ 2022-03-03

nordicDSC

Applicant Nordicneurolab AS

K number K212720

View details →

LLZ 2022-02-23

EzOrtho v1.3

Applicant Ewoosoft Co., Ltd.

K number K220003

View details →

LLZ 2022-02-08

Rapid

Applicant Ischemaview, Inc.

K number K213165

View details →

LLZ 2022-02-04

Veuron-Brain-pAb2

Applicant Heuron Co., Ltd.

K number K213801

View details →

LLZ 2022-01-14

Quantib ND

Applicant Quantib B.V.

K number K213737

View details →

LLZ 2022-01-12

UNiD Spine Analyzer

Applicant Medicrea International, Inc.

K number K212005

View details →

LLZ 2022-01-07

AIBOLIT 3D+

Applicant Aibolit Technologies, LLC

K number K211443

View details →

LLZ 2022-01-03

VUZE System

Applicant Vuze Medical , Ltd.

K number K210830

View details →

LLZ 2021-12-29

CONVIVO In Vivo Pathology Suite

Applicant Carl Zeiss Meditec, AG

K number K211156

View details →

LLZ 2021-12-22

Claritas iPET

Applicant Claritas Healthtech Pte, Ltd.

K number K213140

View details →

LLZ 2021-12-17

Libby IAAA v1.0

Applicant Dyad Medical, Inc.

K number K210931

View details →

LLZ 2021-12-16

Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio

Applicant Brainlab AG

K number K212420

View details →

LLZ 2021-12-15

Will3D

Applicant Hdx Will Corp.

K number K211114

View details →

LLZ 2021-12-15

BIT-Motion

Applicant Dde Mri Solutions, Ltd.

K number K211039

View details →

LLZ 2021-12-10

X-Clever

Applicant Lg Electronics.Inc

K number K212137

View details →

LLZ 2021-12-10

EXA

Applicant Konica Minolta Healthcare Americas, Inc.

K number K203743

View details →

LLZ 2021-12-03

PVmed Contouring Software

Applicant Perception Vision Medical Technologies Ltd.Co.

K number K210916

View details →

LLZ 2021-12-03

ImplaStation

Applicant Prodigident, Inc.

K number K210241

View details →

LLZ 2021-11-23

Myomics Q

Applicant Phantomics, Inc.

K number K211432

View details →

LLZ 2021-11-12

MiPACS HTML5 Web Viewer

Applicant Lead Technologies, Inc.

K number K212984

View details →

LLZ 2021-11-12

MAMMOVISTA B.smart

Applicant Siemens Medical Solutions USA, Inc.

K number K212621

View details →

LLZ 2021-11-12

Intellijoint VIEW

Applicant Intellijoint Surgical, Inc.

K number K211876

View details →

LLZ 2021-11-10

RTapp

Applicant Segana, Inc.

K number K212887

View details →

LLZ 2021-11-10

inVisionOS

Applicant Precisionos Technology, Inc.

K number K210344

View details →

LLZ 2021-11-08

Hura CTP v1.0

Applicant Hura Imaging, Inc.

K number K212550

View details →

LLZ 2021-11-08

GIQuant

Applicant Motilent, Ltd.

K number K211356

View details →

LLZ 2021-11-05

Visible Patient Suite

Applicant Visible Patient, Sas

K number K212896

View details →

LLZ 2021-11-02

VisionX 3.0

Applicant Durr Dental SE

K number K213326

View details →

LLZ 2021-10-29

ATEC Alignment App

Applicant Alphatec Spine, Inc.

K number K211987

View details →

LLZ 2021-10-22

FlightPlan for Liver

Applicant GE Medical Systems SCS

K number K210807

View details →

LLZ 2021-10-20

iRAD

Applicant Claritas Healthtech Pte, Ltd.

K number K212470

View details →

LLZ 2021-10-18

Change Healthcare Cardiology

Applicant Change Healthcare Israel , Ltd.

K number K212528

View details →

LLZ 2021-10-14

SwiftMR

Applicant Airs Medical, Inc.

K number K210999

View details →

LLZ 2021-10-14

Brainance MD

Applicant Advantis Medical Imaging Single Member P.C.

K number K202808

View details →

LLZ 2021-10-05

NAVIPLAN - CT Planning Software for Total Hip Replacement

Applicant Naviswiss AG

K number K211429

View details →

LLZ 2021-10-04

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

Applicant Ewoosoft Co., Ltd.

K number K211795

View details →

LLZ 2021-09-29

ImmersiveTouch

Applicant Immersivetouch, Inc.

K number K210726

View details →

LLZ 2021-09-28

EzDent Web

Applicant Ewoosoft Co., Ltd.

K number K211700

View details →

LLZ 2021-09-24

Collaboration Live

Applicant Philips Ultrasound, Inc.

K number K212777

View details →

LLZ 2021-09-23

JiveX (Model Number / Release: 5.3)

Applicant Visus Health IT GmbH

K number K212321

View details →

LLZ 2021-09-13

KONICAMINOLTA DI-X1

Applicant Konica Minolta, Inc.

K number K212685

View details →

LLZ 2021-09-10

EFAI PACS Picture Archiving and Communication System

Applicant Ever Fortune.Ai, Co., Ltd.

K number K211257

View details →

LLZ 2021-09-10

Kinepict Medical Imaging Tool 4.0

Applicant Kinepict Health, Ltd.

K number K202056

View details →

LLZ 2021-09-03

ADAS 3D

Applicant Adas3D Medical S.L.

K number K212421

View details →

LLZ 2021-08-27

RBknee

Applicant Radiobotics Aps

K number K203696

View details →

LLZ 2021-08-23

EzOrtho

Applicant Ewoosoft Co., Ltd.

K number K211793

View details →

LLZ 2021-08-20

Ez3D-i/E3

Applicant Ewoosoft Co., Ltd.

K number K211791

View details →

LLZ 2021-08-17

ROSA Hip System

Applicant Orthosoft D/B/A Zimmer Cas

K number K210998

View details →

LLZ 2021-08-17

Brain Perfusion (BP) application

Applicant Philips Medical Systems Nederland B.V.

K number K201573

View details →

LLZ 2021-08-16

TruSPECT Radiological Image Processing Station

Applicant Spectrum Dynamics Medical, Ltd.

K number K212230

View details →

LLZ 2021-08-12

eVolve PACS

Applicant Evolve Pacs, Inc.

K number K211863

View details →

LLZ 2021-08-02

DynaCAD

Applicant Invivo Corporation

K number K212175

View details →

LLZ 2021-07-27

ClariCT.AI

Applicant Claripi, Inc.

K number K212074

View details →

LLZ 2021-07-27

aPROMISE

Applicant Exini Diagnostics AB

K number K211655

View details →

LLZ 2021-07-27

Volpara Imaging Software

Applicant Volpara Health Technologies Limited

K number K211279

View details →

LLZ 2021-07-23

MySpine WebPlanner & MyBalance

Applicant Medacta International S.A.

K number K211386

View details →

LLZ 2021-07-20

ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray

Applicant Zirkonzahn Srl

K number K203765

View details →

LLZ 2021-07-08

NubeX

Applicant Techheim Co., Ltd.

K number K211480

View details →

LLZ 2021-07-08

PRE-SURE

Applicant Lazarus 3D, Inc.

K number K201835

View details →

LLZ 2021-07-07

ONE Planner Hip

Applicant Orthosoft D/B/A Zimmer Cas

K number K210653

View details →

LLZ 2021-06-25

3D Echo v1.1

Applicant Jointvue, LLC

K number K211656

View details →

LLZ 2021-06-16

Qmenta Care Platform Family

Applicant Mint Labs, Inc., D/B/A. Qmenta

K number K202718

View details →

LLZ 2021-05-27

ZedView

Applicant Lexi Co., Ltd.

K number K200704

View details →

LLZ 2021-05-21

Universal Viewer

Applicant GE Healthcare

K number K211312

View details →

LLZ 2021-05-20

Xoran Workstation, Model 10050

Applicant Xoran Technologies, LLC

K number K210257

View details →

LLZ 2021-05-19

Overjet Dental Assist

Applicant Overjet, Inc.

K number K210187

View details →

LLZ 2021-05-17

Cercare Medical Neurosuite

Applicant Cercare Medical Aps

K number K202793

View details →

LLZ 2021-05-14

HOLOSCOPE-i

Applicant Real View Imaging , Ltd.

K number K210072

View details →

LLZ 2021-05-06

ImagePilot

Applicant Konica Minolta, Inc.

K number K210066

View details →

LLZ 2021-05-04

SOTA Cloud Imaging

Applicant Sota Precision Optics, Inc. Dba Sota Imaging

K number K210682

View details →

LLZ 2021-05-04

PtoleMedic System

Applicant Lento Medical Innovation, Inc.

K number K202521

View details →

LLZ 2021-04-09

DeepLook PRECISE

Applicant Deeplook, Inc.

K number K202084

View details →

LLZ 2021-04-05

ADAS 3D

Applicant Adas3D Medical S.L.

K number K210850

View details →

LLZ 2021-04-01

Simpleware ScanIP Medical

Applicant Synopsys (Northern Europe) , Ltd.

K number K203195

View details →

LLZ 2021-03-31

SIS System (Version 5.1.0)

Applicant Surgical Information Sciences, Inc.

K number K210071

View details →

LLZ 2021-03-09

Quicktome

Applicant Omniscient Neurotechnology Pty Ltd (O8t)

K number K203518

View details →

LLZ 2021-02-26

Cuptimize

Applicant Cuptimize, Inc.

K number K203651

View details →

LLZ 2021-02-26

SubtleMR

Applicant Subtle Medical, Inc.

K number K203182

View details →

LLZ 2021-02-25

NinesMeasure

Applicant Nines, Inc.

K number K202990

View details →

LLZ 2021-02-19

TruPlan

Applicant Circle Cardiovascular Imaging, Inc.

K number K202212

View details →

LLZ 2021-02-19

MyPAO Planning Report

Applicant Medacta International S.A.

K number K200589

View details →

LLZ 2021-02-18

PhantomMSK Hip

Applicant OrthoGrid Systems, Inc.

K number K210136

View details →

LLZ 2021-02-16

Vitrea Software Package, VSTP-001A

Applicant Canon Medical Systems Corporation

K number K203312

View details →

LLZ 2021-02-09

Synapse 3D, Synapse 3D Base Tools v6.1

Applicant Fujifilm Corporation

K number K203103

View details →

LLZ 2021-02-05

Bonelogic

Applicant Disior, Ltd.

K number K203290

View details →

LLZ 2021-02-04

QUIBIM Precision Prostate (qp-Prostate)

Applicant Quibim S.L.

K number K203582

View details →

LLZ 2021-01-26

IBM iConnect Access

Applicant Merge Healthcare Incorporated

K number K203104

View details →

LLZ 2021-01-15

ViewPoint 6

Applicant GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

K number K203677

View details →

LLZ 2021-01-15

Veuron-Brain-pAb

Applicant Heuron Co., Ltd.

K number K203142

View details →

LLZ 2021-01-15

AccuBrain

Applicant Brainnow Medical Technology Limited

K number K202847

View details →

LLZ 2021-01-07

BrainInsight

Applicant Hyperfine Research, Inc.

K number K202414

View details →

LLZ 2020-12-22

AI Metrics

Applicant Ai Metrics, LLC

K number K202229

View details →

LLZ 2020-12-18

SQuEEZ Software

Applicant Cardiowise, Inc.

K number K201250

View details →

LLZ 2020-12-04

Nucleus.io

Applicant Nucleushealth, LLC

K number K203249

View details →