ClearanceBrief
Panels › Radiology › Product code LLZ · Class 2

System, Image Processing, Radiological

Regulation 892.2050

48510(k)s in 12 months (2,295 all time)
25recalls in 12 months (562 all time)
544recalls 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
Dec 22, 2020K202229AI Metrics
Ai Metrics, LLC
LLZ
Dec 18, 2020K201250SQuEEZ Software
Cardiowise, Inc.
LLZ
Dec 4, 2020K203249Nucleus.io
Nucleushealth, LLC
LLZ
Dec 4, 2020K202487HealthJOINT
Zebra Medical Vision, Ltd., IL
LLZ
Dec 2, 2020K200572Planmeca Romexis
Planmeca Oy, FI
LLZ
Nov 20, 2020K203156DTX Studio Clinic
Nobel Biocare AB, SE
LLZ
Nov 20, 2020K202805Optimized Positioning System (OPS) Insight
Corin USA
LLZ
Nov 20, 2020K193287CorInsights MRI
Adm Diagnostics, Inc.
LLZ
Nov 18, 2020K203287DBSWIN, VISTAEASY
Dürr Dental SE, DE
LLZ
Nov 17, 2020K193306PROView
GE Medical Systems SCS
LLZ
Nov 6, 2020K200750Neuro.Al Algorithm
Terarecon,Inc.
LLZ
Nov 4, 2020K200350MyHip Planner & Verifier
Medacta International S.A., CH
LLZ
Oct 29, 2020K203058CloudVue
International Medical Solutions, Inc., CA
LLZ
Oct 27, 2020K202519OrthoNext Platform System
Orthofix Srl, IT
LLZ
Oct 22, 2020K202948EzOrtho
Ewoosoft Co., Ltd., KR
LLZ
Oct 16, 2020K201710A View LCS
Coreline Soft Co., Ltd., KR
LLZ
Oct 11, 2020K202501Quantib Prostate
Quantib B.V., NL
LLZ
Oct 8, 2020K200810IPS CaseDesigner
Nobel Biocare AB, SE
LLZ
Oct 5, 2020K202292UDE
Ebm Technologies, Inc., TW
LLZ
Oct 2, 2020K202280Cleerly Labs v2.0
Cleerly, Inc.
LLZ
Sep 30, 2020K201928e-Ortho Shoulder Software
FH Industrie, FR
LLZ
Sep 30, 2020K192051THINQ
Corticometrics, LLC
LLZ
Sep 25, 2020K201103Xeleris V Processing and Review Systems
GE Healthcare, IL
LLZ
Sep 20, 2020K200603AAA Model
Philips Ultrasound, Inc.
LLZ
Sep 18, 2020K200852EchoPAC Software Only, EchoPAC Plug-In
GE Medical Systems Ultrasound and Primary Care Diagnostics
LLZ
Sep 18, 2020K192890SentEP
Sentiar, Inc.
LLZ
Sep 16, 2020K201369AVA (Augmented Vascular Analysis)
See-Mode Technologies Pte, Ltd., SG
LLZ
Sep 15, 2020K201665Collaboration Live
Philips Ultrasound, Inc.
LLZ
Sep 11, 2020K202297Aline Ablation Intelligence
Mirada Medical, Ltd., GB
LLZ
Sep 9, 2020K2022563Shape Implant Studio
3Shape Medical A/S, DK
LLZ
Sep 9, 2020K201948AcroDTI Visualizer
Acroviz, Inc., TW
LLZ
Sep 4, 2020K202335Ambra ProViewer
Dicom Grid Inc Dba Ambra Health
LLZ
Aug 27, 2020K200973Synapse 3D Cardiac Tools
Fujifilm Corporaton, JP
LLZ
Aug 26, 2020K200714AVIEW
Coreline Soft Co., Ltd., KR
LLZ
Aug 21, 2020K202116EzDent-i/ E2/ Prora View/ Smart M Viewer
Ewoosoft Co., Ltd., KR
LLZ
Aug 17, 2020K2013523D Auto LAA
Philips Health Care
LLZ
Aug 14, 2020K201632TOMTEC-ARENA
Tomtec Imaging Systems GmbH, DE
LLZ
Aug 13, 2020K201232Limbus Contour
Limbus Ai, Inc., CA
LLZ
Aug 13, 2020K200822Braid
Braid.Health
LLZ
Jul 17, 2020K201465SuRgical Planner (SRP) BrainStorm
Surgical Theater, Inc.
LLZ
Jul 17, 2020K201365True 3D Viewer
Echopixel, Inc.
LLZ
Jul 10, 2020K193294AI-Rad Companion Engine
Siemens Medical Solutions USA, Inc.
LLZ
Jul 9, 2020K201296i-Rapha Solution
Irm, Inc., KR
LLZ
Jul 1, 2020K201477syngo.via View&GO
Siemens Healthcare GmbH, DE
LLZ
Jun 26, 2020K193042Optimized Positioning System (OPS) ReView
Corin USA
LLZ
Jun 17, 2020K193290AI-Rad Companion Brain MR
Siemens Medical Solutions USA, Inc.
LLZ
Jun 15, 2020K200899Quantib AI Node
Quantib B.V., NL
LLZ
Jun 11, 2020K192630uWS-MI
Shanghai United Imaging Healthcare Co., Ltd., CN
LLZ
Jun 2, 2020K201202MI View&GO
Siemens Medical Solutions USA, Inc.
LLZ
May 28, 2020K192692Brainomix 360 e-CTA
Brainomix Limited, GB
LLZ

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