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 2023-06-07

Ambra PACS

Applicant Dicom Grid Dba Ambra Health

K number K231360

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LLZ 2023-06-06

Olea S.I.A. Neurovascular V1.0

Applicant Olea Medical

K number K223532

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LLZ 2023-06-01

Brainomix 360 e-CTP

Applicant Brainomix Limited

K number K223555

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LLZ 2023-05-30

KBA3D

Applicant S.M.A.I.O

K number K223841

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LLZ 2023-05-30

Quicktome Software Suite

Applicant Omniscient Neurotechnology Pty Ltd (O8t)

K number K222359

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LLZ 2023-05-26

Pre-Sure

Applicant Lazarus 3D

K number K230044

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LLZ 2023-05-24

Avatar Medical Software V1

Applicant Avatar Medical

K number K222035

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LLZ 2023-05-23

ROSA Hip System

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

K number K231162

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LLZ 2023-05-23

ADAS 3D

Applicant Adas3D Medical S.L.

K number K230803

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LLZ 2023-05-19

Autoplaque

Applicant Cedars-Sinai Medical Center: Aim

K number K212758

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LLZ 2023-05-12

iTFlow

Applicant Cardio Flow Design, Inc.

K number K222854

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LLZ 2023-05-11

SubtleMR (2.3.x)

Applicant Subtle Medical, Inc.

K number K223623

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LLZ 2023-05-10

Akunah REFLECT

Applicant Akunah Pty, Ltd.

K number K222987

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LLZ 2023-05-10

Neurophet AQUA

Applicant Neurophet., Inc.

K number K220437

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LLZ 2023-05-02

3D Anatomic Model

Applicant Ricoh USA, Inc.

K number K230119

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LLZ 2023-05-01

CarnaLife Holo

Applicant Medapp S.A.

K number K221870

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LLZ 2023-04-26

MR DWI/FLAIR Measurement V1.0

Applicant Olea Medical

K number K230552

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LLZ 2023-04-25

Konicaminolta DI-X1

Applicant Konica Minolta, Inc.

K number K230906

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LLZ 2023-04-21

EzDent Web

Applicant Ewoosoft Co., Ltd.

K number K230468

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LLZ 2023-04-17

Quantib Prostate

Applicant Quantib B.V.

K number K230772

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LLZ 2023-04-13

UniCam Evo Software

Applicant Inter Medical Medizintechnik GmbH

K number K230393

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LLZ 2023-04-13

Ezra Flash

Applicant Ezra Ai, Inc.

K number K230264

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LLZ 2023-04-11

Augmento

Applicant Deeptek Medical Imaging Private Limited

K number K222781

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LLZ 2023-04-07

Limbus Contour

Applicant Limbus Ai, Inc.

K number K230575

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LLZ 2023-03-31

RadAlly

Applicant Imaging Wave, LLC

K number K213660

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LLZ 2023-03-31

CereFlow™ V1.2

Applicant Translational Mri, LLC

K number K211059

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LLZ 2023-03-29

InterView XP; InterView FUSION

Applicant Mediso Medical Imaging Systems, Lttd.

K number K221984

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LLZ 2023-03-21

Syngo Carbon Space VA30A

Applicant Siemens Healthcare GmbH

K number K230561

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LLZ 2023-03-21

FlightPlan for Embolization

Applicant GE Medical Systems SCS

K number K223490

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LLZ 2023-03-03

CoverScan (CoverScan v1.1)

Applicant Perspectum

K number K230294

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LLZ 2023-03-01

Advantis Platform

Applicant Advantis Medical Imaging Single Member P.C.

K number K222975

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LLZ 2023-03-01

Xeleris V Processing and Review System

Applicant GE Healthcare

K number K221680

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LLZ 2023-02-24

Clarus Viewer

Applicant Clarus Viewer Corporation

K number K222757

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LLZ 2023-02-24

RealNow

Applicant Yiwei Medical Technology Co., Ltd.

K number K213891

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LLZ 2023-02-17

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

Applicant Ewoosoft Co., Ltd.

K number K223820

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LLZ 2023-02-13

syngo.via View&GO VA40A

Applicant Siemens Healthcare GmbH

K number K230196

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LLZ 2023-02-10

MD.ai Viewer

Applicant Mdai, Inc.

K number K223425

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LLZ 2023-02-02

Atomica Planner

Applicant Atomica Technology, Inc.

K number K230012

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LLZ 2023-01-20

Advanced MyHip Planner

Applicant Medacta International S.A.

K number K221725

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LLZ 2023-01-19

PerfusionGo Plus

Applicant Yukun (Beijing) Technology Co., Ltd.

K number K221627

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LLZ 2023-01-18

TruPlan Computed Tomography (CT) Imaging Software

Applicant Circle Cardiovascular Imaging, Inc.

K number K222593

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LLZ 2023-01-17

MIM – Additional Tracers

Applicant Mim Software, Inc.

K number K223800

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LLZ 2023-01-17

Elucis

Applicant Realize Medical, Inc.

K number K220649

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LLZ 2023-01-13

MR Diffusion Perfusion Mismatch V1.0

Applicant Olea Medical

K number K223502

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LLZ 2023-01-12

MAMMOVISTA B.smart (VB70)

Applicant Siemens Medical Solutions USA, Inc.

K number K223363

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LLZ 2023-01-12

AIBOLIT 3D+

Applicant Aibolit Technologies, LLC

K number K222458

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LLZ 2023-01-09

Vitrea Software Package, VSTP-002A

Applicant Canon Medical Systems Corporation

K number K223336

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LLZ 2023-01-06

TECHFIT Diagnostic Models

Applicant Techfit Digital Surgery, Inc.

K number K222577

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LLZ 2023-01-04

OnyxCeph

Applicant Image Instruments GmbH

K number K213263

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LLZ 2022-12-30

PeekMed web (v1)

Applicant Peek Health, S.A.

K number K222767

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LLZ 2022-12-30

aprevo® Digital Workflow

Applicant Carlsmed, Inc.

K number K222195

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LLZ 2022-12-30

Cyware 4H and Cysart 4H

Applicant Abys Medical

K number K221796

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LLZ 2022-12-23

Xenoview VDP

Applicant Polarean, Inc.

K number K223071

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LLZ 2022-12-06

MedDream

Applicant Softneta Uab

K number K222320

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LLZ 2022-11-28

TorchTM Software

Applicant Voximetry, Incorporated

K number K220630

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LLZ 2022-11-25

VSI HoloMedicine

Applicant Apoqlar GmbH

K number K213215

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LLZ 2022-11-22

Vision 2, EVARVision, TrackVision 2, HeartVision 2

Applicant GE Medical Systems SCS

K number K223152

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LLZ 2022-11-22

Denti.AI Auto-Chart

Applicant Denti.Ai Technology, Inc.

K number K222054

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LLZ 2022-11-22

Minimally Invasive Prostate Surgery Navigation System

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

K number K221499

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LLZ 2022-11-22

AccuCTP

Applicant ArteryFlow Technology Co., Ltd.

K number K220663

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LLZ 2022-11-17

OmegaAI Image Viewer

Applicant Ramsoft, Inc.

K number K222476

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LLZ 2022-11-10

Synapse 3D Base Tools v6.6

Applicant Fujifilm Corporation

K number K221677

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LLZ 2022-11-01

Dolphin Blue Imaging

Applicant Patterson Dental Supply, Inc.

K number K221478

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LLZ 2022-10-25

3Dicom MD

Applicant Singular Health Pty, Ltd.

K number K222470

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LLZ 2022-10-21

IntraOp VSP Software Device

Applicant Xironetic, LLC

K number K213128

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LLZ 2022-10-14

Vitrea CT Cardiac Analysis

Applicant Canon Medical Informatics, Inc.

K number K222662

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LLZ 2022-10-14

syngo.via View&GO

Applicant Siemens Healthcare GmbH

K number K221501

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LLZ 2022-09-30

e-Ortho Shoulder Software v1.1

Applicant FH Industrie

K number K220758

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LLZ 2022-09-06

Ez3D-i/E3

Applicant Ewoosoft Co., Ltd.

K number K222069

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LLZ 2022-08-19

AXIR-CX

Applicant Radisen Co., Ltd.

K number K213520

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LLZ 2022-08-17

WebCeph

Applicant Assemblecircle Corp.

K number K220903

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LLZ 2022-08-16

syngo Application Software (VE21)

Applicant Siemens Medical Solution USA, Inc.

K number K220433

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LLZ 2022-08-12

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

Applicant Ewoosoft Co., Ltd.

K number K222145

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LLZ 2022-08-12

TeraRecon Neuro

Applicant Terarecon,Inc.

K number K220349

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LLZ 2022-08-08

Dolphin Imaging 12.0

Applicant Patterson Dental Supply, Inc.

K number K222072

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LLZ 2022-08-05

Neurophet SCALE PET

Applicant Neurophet., Inc.

K number K221405

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LLZ 2022-07-22

AI4CMR v1.0

Applicant Ai4medimaging Medical Solutions S.A.

K number K220624

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LLZ 2022-07-22

FX SPS

Applicant Pixee Medical

K number K213922

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LLZ 2022-07-20

AutoSeg

Applicant Ai Medic, Inc.

K number K220039

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LLZ 2022-07-06

Functional MR V1.0

Applicant Olea Medical S.A.S.

K number K221426

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LLZ 2022-06-23

Axial3D Cloud Segmentation Service

Applicant Axial Medical Printing Limited

K number K221511

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LLZ 2022-06-21

Syngo Carbon Space VA20A

Applicant Siemens Healthcare GmbH

K number K213665

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LLZ 2022-06-17

ElucidVivo A.3

Applicant Elucid Bioimaging, Inc.

K number K221463

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LLZ 2022-06-15

SurgiCase Viewer

Applicant Materialise NV

K number K213684

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LLZ 2022-06-10

MediLab

Applicant Sigma Scientific Services, LLC

K number K221065

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LLZ 2022-06-03

3D Anatomic Models

Applicant Ricoh USA, Inc.

K number K220205

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LLZ 2022-05-31

EchoNavigator R4.0

Applicant Philips Medical Systems Nederland B.V.

K number K221270

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LLZ 2022-05-25

SwiftMR

Applicant Airs Medical, Inc.

K number K220416

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LLZ 2022-05-23

ON3D

Applicant 3D Ons, Inc.

K number K221000

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LLZ 2022-05-20

syngo Dynamics (Version VA40E)

Applicant Siemens Medical Solutions USA, Inc.

K number K220832

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LLZ 2022-05-19

CoverScan v1

Applicant Perspectum, Ltd.

K number K212565

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LLZ 2022-05-16

Caas Qardia

Applicant Pie Medical Imaging BV

K number K212376

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LLZ 2022-05-13

Quantib Prostate

Applicant Quantib B.V.

K number K221106

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LLZ 2022-05-10

inHEART MODELS

Applicant Inheart, Sas

K number K220727

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LLZ 2022-05-06

KEOPS Balance Analyzer 3D

Applicant S.M.A.I.O

K number K213975

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LLZ 2022-05-06

Segment 3DPrint

Applicant Medviso AB

K number K211966

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LLZ 2022-05-03

exoplan

Applicant Exocad GmbH

K number K213302

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LLZ 2022-04-29

Oryx Cloud Imaging

Applicant Oryx Dental Software, Inc.

K number K220684

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LLZ 2022-04-29

aPROMISE X

Applicant Exini Diagnostics AB

K number K220590

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LLZ 2022-04-28

AngioCloud Service

Applicant Angiocloud, LLC

K number K211713

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