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 2024-12-20

aprevo® Digital Planning

Applicant Carlsmed, Inc.

K number K242599

View details →

LLZ 2024-12-20

Lightning Viewer

Applicant Nexsys Electronics Inc. Dba Medweb

K number K242362

View details →

LLZ 2024-12-06

Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert

Applicant Cercare Medical A/S

K number K241989

View details →

LLZ 2024-12-06

PeekMed web

Applicant Peek Health, S.A.

K number K240926

View details →

LLZ 2024-12-05

Rapid Surgical Plan (RSP-SW-001)

Applicant Navbit Pty, Ltd.

K number K243447

View details →

LLZ 2024-11-26

RadUnity (Version 1.0.0)

Applicant Radunity Corp.

K number K242810

View details →

LLZ 2024-11-21

Jazz Classic

Applicant Jazz Imaging

K number K241495

View details →

LLZ 2024-11-18

CT Collaboration Live

Applicant Philips Healthcare (Suzhou) Co., Ltd.

K number K242329

View details →

LLZ 2024-11-15

1CMR Pro

Applicant Mycardium AI Limited

K number K242062

View details →

LLZ 2024-11-12

Change Healthcare Stratus Imaging PACS

Applicant Change Healthcare Canada Company

K number K241981

View details →

LLZ 2024-11-04

JLK-PWI

Applicant JLK, Inc.

K number K242709

View details →

LLZ 2024-10-31

eRAD PACS

Applicant Erad, Inc.

K number K241223

View details →

LLZ 2024-10-24

ROCC Console

Applicant Philips Medical Systems Nederland B.V.

K number K242512

View details →

LLZ 2024-10-23

MIM – Symphony HDR Fusion

Applicant Mim Software, Inc.

K number K243012

View details →

LLZ 2024-10-22

nordicMEDiVA

Applicant Nordicneurolab AS

K number K243209

View details →

LLZ 2024-10-16

JLK-CTP

Applicant JLK, Inc.

K number K242556

View details →

LLZ 2024-10-15

VINT

Applicant Mediimg Corporation

K number K240385

View details →

LLZ 2024-10-11

syngo Application Software

Applicant Siemens Medical Solutions USA, Inc.

K number K241569

View details →

LLZ 2024-09-23

EConsole2

Applicant DRTECH Corporation

K number K240243

View details →

LLZ 2024-09-12

Elucid PlaqueIQ

Applicant Elucid Bioimaging, Inc.

K number K241524

View details →

LLZ 2024-09-05

TRAQinform IQ

Applicant Aiq Global, Inc.

K number K233998

View details →

LLZ 2024-08-23

SonoSync

Applicant Samsung Medison Co., Ltd.

K number K241302

View details →

LLZ 2024-08-21

AiMIFY (1.x)

Applicant Subtle Medical, Inc.

K number K240290

View details →

LLZ 2024-08-13

Bullsai

Applicant Turing Medical Technologies, Inc.

K number K241094

View details →

LLZ 2024-08-08

SynthVISION 1.0.0

Applicant Synthesis Health Intelligence, Inc.

K number K240724

View details →

LLZ 2024-08-05

Orthopaedic Surgery Planning Software (AIJOINT)

Applicant Longwood Valley Medical , Ltd.

K number K233761

View details →

LLZ 2024-07-23

EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)

Applicant Ewoosoft Co., Ltd.

K number K241114

View details →

LLZ 2024-07-18

vRad Viewer

Applicant Virtual Radiologic Corporation

K number K241879

View details →

LLZ 2024-07-17

MICSI-RMT

Applicant Microstructure Imaging, Inc.

K number K241121

View details →

LLZ 2024-07-17

Vitrea Software Package, VSTP-002A V2.0

Applicant Canon Medical Systems Corporation

K number K240705

View details →

LLZ 2024-07-02

ViewPoint 6

Applicant Ge Healthcare GmbH

K number K241300

View details →

LLZ 2024-07-01

cNeuro cDAT

Applicant Combinostics OY

K number K233908

View details →

LLZ 2024-06-28

nordicMEDiVA

Applicant Nordicneurolab AS

K number K241608

View details →

LLZ 2024-06-17

MediOMx

Applicant Pmx, Inc.

K number K233331

View details →

LLZ 2024-05-31

Bone Suppression Software

Applicant Konica Minolta, Inc.

K number K240281

View details →

LLZ 2024-05-31

Mimics Enlight CMF

Applicant Materialise NV

K number K223427

View details →

LLZ 2024-05-23

Syngo Carbon Enterprise Access (VA40A)

Applicant Siemens Healthcare GmbH

K number K240294

View details →

LLZ 2024-05-21

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

Applicant Brainlab AG

K number K232759

View details →

LLZ 2024-05-20

MIM - Centiloid Scaling

Applicant Mim Software, Inc.

K number K233620

View details →

LLZ 2024-05-13

MIM – Monte Carlo Dosimetry

Applicant Mim Software, Inc.

K number K232862

View details →

LLZ 2024-05-09

VUZE System

Applicant Vuze Medical , Ltd.

K number K232976

View details →

LLZ 2024-05-06

MIM – Dose Analysis

Applicant Mim Software, Inc.

K number K232514

View details →

LLZ 2024-04-29

SubtleREFORMAT (1.x)

Applicant Subtle Medical, Inc.

K number K233699

View details →

LLZ 2024-04-24

OpenRad Cloud

Applicant Openrad Services Uk, Ltd.

K number K240839

View details →

LLZ 2024-04-24

Image Management V15

Applicant Philips Medical Systems Technologies

K number K240822

View details →

LLZ 2024-04-22

Rapid

Applicant Ischemaview, Inc.

K number K233582

View details →

LLZ 2024-04-10

Neorad Pacs (Neorad Pacs)

Applicant Everrtech Software Pvt, Ltd.

K number K232641

View details →

LLZ 2024-03-27

CARPL (CARPL)

Applicant Carpl Ai, Inc.

K number K232891

View details →

LLZ 2024-03-25

Cube Navigator

Applicant Medical Templates AG

K number K240620

View details →

LLZ 2024-03-18

nCommand Lite System

Applicant Ionic Health

K number K233660

View details →

LLZ 2024-03-18

X-Clever (ASHK100G)

Applicant Lg Electronics.Inc

K number K233599

View details →

LLZ 2024-03-13

MRCP+ version 2 (MRCP+ v2)

Applicant Perspectum

K number K233930

View details →

LLZ 2024-03-06

Autofuse

Applicant Pymedix

K number K233572

View details →

LLZ 2024-02-12

Mimics Cardiac Planner

Applicant Materialise NV

K number K233217

View details →

LLZ 2024-02-08

Aid-U

Applicant Iaid

K number K231662

View details →

LLZ 2024-02-01

Augmented Reality Application

Applicant Sira Medical, Inc.

K number K232339

View details →

LLZ 2024-02-01

CAAS MR Solutions

Applicant Pie Medical Imaging BV

K number K232007

View details →

LLZ 2024-01-31

CEPHX- Cephalometric Analysis Software

Applicant Orca Dental AI , Ltd.

K number K231396

View details →

LLZ 2024-01-25

BreView

Applicant GE Medical Systems SCS

K number K233714

View details →

LLZ 2024-01-24

Axial3D Cloud Segmentation Service

Applicant Axial Medical Printing Limited

K number K231607

View details →

LLZ 2024-01-17

FlexView Diagnostic (v1.1.20)

Applicant Radical Imaging, LLC

K number K233226

View details →

LLZ 2024-01-03

Horos MD™

Applicant Icat Solutions, Ltd.

K number K232589

View details →

LLZ 2023-12-21

syngo Virtual Cockpit (VB10A)

Applicant Siemens Healthcare GmbH

K number K232744

View details →

LLZ 2023-12-20

uOmnispace.MI

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K number K233176

View details →

LLZ 2023-12-20

syngo Application Software

Applicant Siemens Medical Solutions USA, Inc.

K number K230955

View details →

LLZ 2023-12-14

StrokeViewer Perfusion

Applicant Nico-Lab B.V.

K number K231570

View details →

LLZ 2023-12-12

TeleScan

Applicant Bb Imaging

K number K233634

View details →

LLZ 2023-12-08

DTX Studio Clinic (4.0)

Applicant Nobel Biocare AB

K number K231898

View details →

LLZ 2023-12-07

Myocardial Strain Software Application

Applicant Circle Cardiovascular Imaging

K number K232661

View details →

LLZ 2023-11-20

TraumaCad Neo

Applicant Brainlab , Ltd.

K number K231498

View details →

LLZ 2023-11-14

BrainSpec Core™ Software

Applicant Brainspec, Inc.

K number K230856

View details →

LLZ 2023-10-27

SwiftMR

Applicant Airs Medical, Inc.

K number K230854

View details →

LLZ 2023-10-24

spineEOS

Applicant Eos Imaging

K number K232086

View details →

LLZ 2023-10-20

R2GATE Lite TM

Applicant Megagen Implant Co., Ltd.

K number K223909

View details →

LLZ 2023-10-18

EConsole1

Applicant DRTECH Corporation

K number K231225

View details →

LLZ 2023-10-16

Ikshana

Applicant Immersivetouch

K number K230249

View details →

LLZ 2023-10-13

Veuron-Brain-pAb3

Applicant Heuron Co., Ltd.

K number K231642

View details →

LLZ 2023-09-26

OFIX MIS App

Applicant Orthofix US, LLC

K number K230252

View details →

LLZ 2023-09-22

Jazz

Applicant Ai Medical AG

K number K223659

View details →

LLZ 2023-09-20

Rology Teleradiology Platform (v.1.22.1103)

Applicant Rology, Inc.

K number K231385

View details →

LLZ 2023-09-14

OrionXR

Applicant Hoth Intelligence, Inc.

K number K232189

View details →

LLZ 2023-09-14

AccuCTP Pro

Applicant ArteryFlow Technology Co., Ltd.

K number K231353

View details →

LLZ 2023-09-14

NEUROShield

Applicant In-Med Prognostics L3c

K number K220034

View details →

LLZ 2023-09-01

UniSyn Molecular Imaging (6-3-1)

Applicant Convergent Imaging Solutions

K number K231047

View details →

LLZ 2023-08-30

Brainomix 360 e-MRI

Applicant Brainomix Limited

K number K231656

View details →

LLZ 2023-08-25

AIRAscore

Applicant Airamed GmbH

K number K223180

View details →

LLZ 2023-08-22

CUPTIMIZE™ Advanced

Applicant DePuy Orthopaedics, Inc.

K number K231503

View details →

LLZ 2023-08-14

SaintView

Applicant Inviz Corporation

K number K223660

View details →

LLZ 2023-08-08

Efai Pacs Picture Archiving and Communication System Pro

Applicant Ever Fortune.Ai, Co., Ltd.

K number K232100

View details →

LLZ 2023-07-25

Patient Specific Planning Solution™ 3D Bone Models

Applicant Biomet Manufacturing Corp

K number K230540

View details →

LLZ 2023-07-24

Argus Cognitive ReVISION Software

Applicant Argus Cognitive, Inc.

K number K223322

View details →

LLZ 2023-07-17

Fibroid Mapping Reviewer Application (FMRA)

Applicant Nesa Medtech Private Limited

K number K222683

View details →

LLZ 2023-07-14

JiveX (Model Number / Release: 5.4)

Applicant Visus Health IT GmbH

K number K231041

View details →

LLZ 2023-07-14

Cercare Medical Neurosuite

Applicant Cercare Medical A/S

K number K230016

View details →

LLZ 2023-07-14

CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)

Applicant Sentiar, Inc.

K number K223290

View details →

LLZ 2023-07-13

Chondral Quant

Applicant Siemens Medical Soultions USA, Inc.

K number K231351

View details →

LLZ 2023-07-13

XR90 (XR90-SYS)

Applicant Mediview Xr, Inc.

K number K223125

View details →

LLZ 2023-06-30

Pixyl.Neuro

Applicant Pixyl SA

K number K213253

View details →

LLZ 2023-06-23

Medisystem Pacs

Applicant Medilab Manutencao E Sitemas Ltda

K number K223048

View details →

LLZ 2023-06-09

CT Perfusion V1.0

Applicant Olea Medical

K number K223091

View details →