ClearanceBrief
Panels › Radiology › Product code LLZ · Class 2

System, Image Processing, Radiological

Regulation 892.2050

49510(k)s in 12 months (2,295 all time)
24recalls in 12 months (561 all time)
543recalls that name a 510(k)
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Top companies in LLZ

Company510(k)sRecalls
Siemens AG Medical Solutions9589
GE Healthcare2384
Merge Healthcare Incorporated661
Carestream Health, Inc.953
Vital Images, Inc.3410
Agfa Corp.634
Totoku Electric Co., Ltd.400
Barco N.V.370
Eizo Nanao Corporation340
Ewoosoft Co., Ltd.290
Decided510(k)Device and applicantCode
Oct 21, 2026K261788Eden PACS
Higia., Inc. d/b/a Eden
LLZ
Oct 21, 2026K261531PV-iCurve Pro
Perception Vision Medical Technology Co., Ltd., CN
LLZ
Sep 29, 2026K263048Syngo Carbon Space (VA4)
Siemens Healthineers AG, DE
LLZ
Sep 23, 2026K261874Syneris PACS v.1.0.1.0
Syneris, CA
LLZ
Sep 22, 2026K262442HipStudio Analysis
Replasia BV, BE
LLZ
Sep 18, 2026K261855Elucid PlaqueIQ
Elucid Bioimaging, Inc.
LLZ
Sep 15, 2026K261861SPINEsim v1.0
Mdsim S.A., LU
LLZ
Sep 15, 2026K254214OOOPDS
Taiwan Main Orthopaedic Biotechnology Co., Ltd., TW
LLZ
Sep 4, 2026K2620603D-RD-S
Radiopharmaceutical Imaging & Dosimetry, LLC
LLZ
Aug 17, 2026K261500KBA3D (v2.4.0)
S.M.A.I.O, FR
LLZ
Aug 14, 2026K262449AdvaView
ADVAHEALTH SOLUTIONS, LLC
LLZ
Aug 12, 2026K261916NeuroQuant PET
Cortechs Labs, Inc.
LLZ
Jul 31, 2026K260936RadioViewAI
Neurocareai, Inc. (Dba Savelife.Ai)
LLZ
Jul 29, 2026K260588Cleerly LABS
Cleerly, Inc.
LLZ
Jul 24, 2026K262462TheraSphere 360™ Y-90 Management Platform
Boston Scientific Corporation
LLZ
Jul 23, 2026K262143ImageGrid StreamVue
Candelis, Inc.
LLZ
Jul 21, 2026K260500ResolutionMD
ResolutionMD, Inc., CA
LLZ
Jul 10, 2026K262120Avara Viewer
Avara Software
LLZ
Jul 9, 2026K2538993D-Anywhere
Provect.AI
LLZ
Jul 6, 2026K261465INDIRA CLOUD VIEWER
INDIGO TECHNOLOGIES, CO
LLZ
Jun 30, 2026K260576MeVis AVM Contour
MeVis Medical Solutions AG, DE
LLZ
Jun 25, 2026K260231MiPACS V5 (1.0.0)
Apryse Software Corp
LLZ
Jun 22, 2026K253421Perfusion Measurement Platform v1
Quantified Imaging Limited, GB
LLZ
Jun 8, 2026K2613522D Hip Planning Software
One Ortho, FR
LLZ
Jun 3, 2026K260116CustoMED Viewer
CustoMED , Ltd., IL
LLZ
May 27, 2026K254265Helion Viewer Suite
Videomed Srl ( a Baxter Healthcare Corp company), IT
LLZ
May 18, 2026K253831CMN Capillary Function with Virtual Expert for MRI, CT and CBCT
Cercare Medical A/S, DK
LLZ
May 14, 2026K254013SubtleHD-PET (1.x)
Subtle Medical, Inc.
LLZ
May 8, 2026K260321HipGuide (V 1.0.0.0)
Orthopedic Driven Imaging, LLC
LLZ
May 4, 2026K260716Neowise
Cefla S.C., IT
LLZ
Apr 24, 2026K260009LungPoint Virtual Bronchoscopic Navigation (VBN) Software
Broncus Medical, Inc.
LLZ
Apr 23, 2026K254237CCI PACS VIEWER (PACS-US-001)
CliniComp, Intl.
LLZ
Mar 31, 2026K253029RW-1
Mediott, Inc., JP
LLZ
Mar 30, 2026K253950Avatar Medical Vision
Avatar Medical, FR
LLZ
Mar 27, 2026K252195ARTICOR planner
Artiness S.R.L, IT
LLZ
Mar 13, 2026K260479TheraSphere 360™ Y-90 Management Platform
Boston Scientific Corporation
LLZ
Mar 13, 2026K253111Aeka Imaging
Good Methods Global, Inc.
LLZ
Mar 12, 2026K251964Mimics Thoracic Planner
Materialise NV, BE
LLZ
Feb 23, 2026K253486SKIA-Head (Model: SKIA-ST00)
Skia, Inc., KR
LLZ
Feb 19, 2026K260205AS Software Version Asera
AS Software, LLC
LLZ
Feb 6, 2026K253927LiveMedica Enterprise PACS
Live Medica, LLC
LLZ
Feb 6, 2026K251577LAIA XR
Augmented Reality Software S.L., ES
LLZ
Jan 8, 2026K2537843DICOM MD Cloud
Singular Health Pty, Ltd., AU
LLZ
Jan 8, 2026K253639View
GE Healthcare
LLZ
Jan 5, 2026K253008maiLink
Maihub Corp., KR
LLZ
Dec 11, 2025K251883MIM – LesionID Pro
Mim Software, Inc.
LLZ
Nov 21, 2025K251880Archy Dental Imaging
Archy Dental, Inc.
LLZ
Nov 20, 2025K253495syngo.MR Applications (VB80)
Siemens Healthineers AG, DE
LLZ
Nov 4, 2025K251410VXvue
Vieworks Co., Ltd., KR
LLZ
Nov 3, 2025K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
Mighty Oak Medical
LLZ

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