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 2026-09-23

Syneris PACS v.1.0.1.0

Applicant Syneris

K number K261874

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LLZ 2026-09-22

HipStudio Analysis

Applicant Replasia BV

K number K262442

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LLZ 2026-09-18

Elucid PlaqueIQ

Applicant Elucid Bioimaging, Inc.

K number K261855

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LLZ 2026-09-15

SPINEsim v1.0

Applicant Mdsim S.A.

K number K261861

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LLZ 2026-09-15

OOOPDS

Applicant Taiwan Main Orthopaedic Biotechnology Co., Ltd.

K number K254214

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LLZ 2026-09-04

3D-RD-S

Applicant Radiopharmaceutical Imaging & Dosimetry, LLC

K number K262060

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LLZ 2026-08-17

KBA3D (v2.4.0)

Applicant S.M.A.I.O

K number K261500

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LLZ 2026-08-14

AdvaView

Applicant ADVAHEALTH SOLUTIONS, LLC

K number K262449

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LLZ 2026-08-12

NeuroQuant PET

Applicant Cortechs Labs, Inc.

K number K261916

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LLZ 2026-07-31

RadioViewAI

Applicant Neurocareai, Inc. (Dba Savelife.Ai)

K number K260936

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LLZ 2026-07-29

Cleerly LABS

Applicant Cleerly, Inc.

K number K260588

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LLZ 2026-07-24

TheraSphere 360™ Y-90 Management Platform

Applicant Boston Scientific Corporation

K number K262462

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LLZ 2026-07-23

ImageGrid StreamVue

Applicant Candelis, Inc.

K number K262143

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LLZ 2026-07-21

ResolutionMD

Applicant ResolutionMD, Inc.

K number K260500

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LLZ 2026-07-10

Avara Viewer

Applicant Avara Software

K number K262120

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LLZ 2026-07-09

3D-Anywhere

Applicant Provect.AI

K number K253899

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LLZ 2026-07-06

INDIRA CLOUD VIEWER

Applicant INDIGO TECHNOLOGIES

K number K261465

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LLZ 2026-06-30

MeVis AVM Contour

Applicant MeVis Medical Solutions AG

K number K260576

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LLZ 2026-06-25

MiPACS V5 (1.0.0)

Applicant Apryse Software Corp

K number K260231

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LLZ 2026-06-22

Perfusion Measurement Platform v1

Applicant Quantified Imaging Limited

K number K253421

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LLZ 2026-06-08

2D Hip Planning Software

Applicant One Ortho

K number K261352

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LLZ 2026-06-03

CustoMED Viewer

Applicant CustoMED , Ltd.

K number K260116

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LLZ 2026-05-27

Helion Viewer Suite

Applicant Videomed Srl ( a Baxter Healthcare Corp company)

K number K254265

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LLZ 2026-05-18

CMN Capillary Function with Virtual Expert for MRI, CT and CBCT

Applicant Cercare Medical A/S

K number K253831

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LLZ 2026-05-14

SubtleHD-PET (1.x)

Applicant Subtle Medical, Inc.

K number K254013

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LLZ 2026-05-08

HipGuide (V 1.0.0.0)

Applicant Orthopedic Driven Imaging, LLC

K number K260321

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LLZ 2026-05-04

Neowise

Applicant Cefla S.C.

K number K260716

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LLZ 2026-04-24

LungPoint Virtual Bronchoscopic Navigation (VBN) Software

Applicant Broncus Medical, Inc.

K number K260009

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LLZ 2026-04-23

CCI PACS VIEWER (PACS-US-001)

Applicant CliniComp, Intl.

K number K254237

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LLZ 2026-03-31

RW-1

Applicant Mediott, Inc.

K number K253029

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LLZ 2026-03-30

Avatar Medical Vision

Applicant Avatar Medical

K number K253950

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LLZ 2026-03-27

ARTICOR planner

Applicant Artiness S.R.L

K number K252195

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LLZ 2026-03-13

TheraSphere 360™ Y-90 Management Platform

Applicant Boston Scientific Corporation

K number K260479

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LLZ 2026-03-13

Aeka Imaging

Applicant Good Methods Global, Inc.

K number K253111

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LLZ 2026-03-12

Mimics Thoracic Planner

Applicant Materialise NV

K number K251964

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LLZ 2026-02-23

SKIA-Head (Model: SKIA-ST00)

Applicant Skia, Inc.

K number K253486

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LLZ 2026-02-19

AS Software Version Asera

Applicant AS Software, LLC

K number K260205

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LLZ 2026-02-06

LiveMedica Enterprise PACS

Applicant Live Medica, LLC

K number K253927

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LLZ 2026-02-06

LAIA XR

Applicant Augmented Reality Software S.L.

K number K251577

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LLZ 2026-01-08

3DICOM MD Cloud

Applicant Singular Health Pty, Ltd.

K number K253784

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LLZ 2026-01-08

View

Applicant GE Healthcare

K number K253639

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LLZ 2026-01-05

maiLink

Applicant Maihub Corp.

K number K253008

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LLZ 2025-12-11

MIM – LesionID Pro

Applicant Mim Software, Inc.

K number K251883

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LLZ 2025-11-21

Archy Dental Imaging

Applicant Archy Dental, Inc.

K number K251880

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LLZ 2025-11-20

syngo.MR Applications (VB80)

Applicant Siemens Healthineers AG

K number K253495

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LLZ 2025-11-04

VXvue

Applicant Vieworks Co., Ltd.

K number K251410

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LLZ 2025-11-03

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

Applicant Mighty Oak Medical

K number K251532

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LLZ 2025-10-28

TheraSphere 360™ Y-90 Management Platform

Applicant Boston Scientific Corporation

K number K252547

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LLZ 2025-10-22

Sirona Advanced Imaging Suite

Applicant Sirona Medical

K number K251030

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LLZ 2025-10-16

Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout

Applicant Brainlab AG

K number K252476

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LLZ 2025-10-15

AGFA HealthCare Enterprise Imaging

Applicant Agfa Healthcare N.V.

K number K252199

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LLZ 2025-10-08

ProKnow DS

Applicant Elekta Solutions AB

K number K251363

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LLZ 2025-10-03

HPACS

Applicant Healthhub

K number K250039

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LLZ 2025-10-02

Philips IntelliSpace Cardiovascular

Applicant Philips Medical Systems Nederland B.V.

K number K251215

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LLZ 2025-09-24

uWS-Angio Pro

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K number K250045

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LLZ 2025-09-12

uWS-Angio

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K number K250040

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LLZ 2025-09-11

Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)

Applicant Augment Intelligent Medical System (China) Co., Ltd.

K number K242314

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LLZ 2025-09-09

AI-Rad Companion Prostate MR

Applicant Siemens Healthcare GmbH

K number K252608

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LLZ 2025-09-04

Image Suite

Applicant Carestream Health, Inc.

K number K251168

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LLZ 2025-08-29

SurgiTwin

Applicant Twinsight

K number K250290

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LLZ 2025-08-26

Rapid DeltaFuse

Applicant Ischemaview, Inc.

K number K252526

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LLZ 2025-08-25

Neurovascular Insight V1.0

Applicant Olea Medical S.A.S.

K number K243680

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LLZ 2025-08-11

RW-1

Applicant Mediott, Inc.

K number K232456

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LLZ 2025-08-07

Navigo Workstation 2.3 (FPRMC00039)

Applicant UC-CARE , Ltd.

K number K250664

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LLZ 2025-08-06

Digital Radiographic Imaging Acquisition Software - DR (RiasDR)

Applicant Shen Zhen Cambridge-Hit Co., Ltd.

K number K251038

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LLZ 2025-08-05

iPETcertum (v1.0)

Applicant Claritas Healthtech Pte, Ltd.

K number K244016

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LLZ 2025-07-23

IMAGE ONE

Applicant Infomed Software, S.L.

K number K250716

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LLZ 2025-07-23

Neuro Insight V1.0

Applicant Olea Medical S.A.S.

K number K243681

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LLZ 2025-07-22

GyriCalc (Version 1.0.0)

Applicant Neurospectrum Insights Corp.

K number K250686

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LLZ 2025-07-15

AV Viewer

Applicant Philips Medical Systems Nederland B.V.

K number K250181

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LLZ 2025-07-14

GECHO

Applicant Narnar, LLC

K number K250120

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LLZ 2025-07-07

CustomSurg OrthoPlanner

Applicant Customsurg AG

K number K251863

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LLZ 2025-06-17

uOmniscan

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K number K243666

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LLZ 2025-06-16

Mosaic (V1.0.1)

Applicant Navier Medical

K number K244012

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LLZ 2025-06-05

UroNav 4

Applicant Philips DS North America, LLC

K number K250800

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LLZ 2025-06-05

TechLive

Applicant DeepHealth, Inc.

K number K243703

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LLZ 2025-05-21

SMARTDent

Applicant Ray Co., Ltd.

K number K251109

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LLZ 2025-05-12

uWS-Angio Basic

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K number K243632

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LLZ 2025-05-02

LUMYS (V1)

Applicant Intradys

K number K243069

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LLZ 2025-04-23

MySpine WebPlanner

Applicant Medacta International S.A.

K number K243697

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LLZ 2025-04-21

VersaViewer

Applicant GE Medical Systems SCS

K number K243651

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LLZ 2025-04-16

MySegmenter (v2.0.0)

Applicant Mysegmenter Technologies, Inc.

K number K242647

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LLZ 2025-04-14

Merge Universal Viewer (MUV)

Applicant Merge Healthcare Incorporated

K number K250301

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LLZ 2025-04-08

Horos Mobile

Applicant Icat Solutions, Ltd.

K number K242552

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LLZ 2025-03-20

brAIn™ Shoulder Positioning

Applicant Avatar Medical

K number K243292

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LLZ 2025-03-18

Radlink GPS Pro Imaging

Applicant Radlink, Inc.

K number K242161

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LLZ 2025-03-17

SERV MEDICAL CDSS

Applicant Serv Medical Pte., Ltd.

K number K241975

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LLZ 2025-03-14

PLANET Onco Dose (3.2)

Applicant Dosisoft SA

K number K241765

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LLZ 2025-02-26

aiCockpit AI Viewer

Applicant Fovia, Inc.

K number K241546

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LLZ 2025-02-25

JLK-AILink

Applicant JLK, Inc.

K number K250348

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LLZ 2025-02-21

QuickRad

Applicant Aikenist Technologies Pvt, Ltd.

K number K242838

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LLZ 2025-02-20

CaRi-Plaque

Applicant Caristo Diagnostics , Ltd.

K number K242240

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LLZ 2025-02-12

AspenView

Applicant Aspen Imaging Healthcare, Inc.

K number K241425

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LLZ 2025-02-04

rTOP

Applicant Roclub GmbH

K number K243333

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LLZ 2025-01-31

ZeTTA PACS

Applicant Tae Young Soft Co., Ltd.

K number K241694

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LLZ 2025-01-23

CephNinja

Applicant Cyncronus, LLC

K number K241819

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LLZ 2025-01-14

SpectoMed (v1.0)

Applicant Specto Medical

K number K242205

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LLZ 2025-01-07

ApolloHipX (THR.SS.0001)

Applicant Corin U.S.A. Limited

K number K241808

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LLZ 2025-01-06

Brainomix 360 e-CTA

Applicant Brainomix Limited

K number K242123

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LLZ 2025-01-03

Clarify DL

Applicant Ge Medical Systems Israel, Functional Imaging

K number K241350

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