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
Apr 29, 2022K220684Oryx Cloud Imaging
Oryx Dental Software, Inc.
LLZ
Apr 29, 2022K220590aPROMISE X
Exini Diagnostics AB, SE
LLZ
Apr 28, 2022K211713AngioCloud Service
Angiocloud, LLC
LLZ
Apr 22, 2022K212981MirrorMe3D Modeling System
Mirrorme3D, LLC
LLZ
Apr 15, 2022K220779XD
Mirada Medical, Ltd., GB
LLZ
Apr 14, 2022K220767TeleScan
Bb Imaging
LLZ
Apr 6, 2022K203783ClariPulmo
Claripi, Inc., KR
LLZ
Mar 25, 2022K213562DTX Studio Clinic 3.0
Nobel Biocare AB, SE
LLZ
Mar 11, 2022K212040RI.HIP MODELER
Blue Belt Technologies, Inc.
LLZ
Mar 3, 2022K212720nordicDSC
Nordicneurolab AS, NO
LLZ
Feb 23, 2022K220003EzOrtho v1.3
Ewoosoft Co., Ltd., KR
LLZ
Feb 8, 2022K213165Rapid
Ischemaview, Inc.
LLZ
Feb 4, 2022K213801Veuron-Brain-pAb2
Heuron Co., Ltd., KR
LLZ
Jan 14, 2022K213737Quantib ND
Quantib B.V., NL
LLZ
Jan 12, 2022K212005UNiD Spine Analyzer
Medicrea International, Inc., FR
LLZ
Jan 7, 2022K211443AIBOLIT 3D+
Aibolit Technologies, LLC
LLZ
Jan 3, 2022K210830VUZE System
Vuze Medical , Ltd., IL
LLZ
Dec 29, 2021K211156CONVIVO In Vivo Pathology Suite
Carl Zeiss Meditec, AG, DE
LLZ
Dec 22, 2021K213140Claritas iPET
Claritas Healthtech Pte, Ltd., SG
LLZ
Dec 17, 2021K210931Libby IAAA v1.0
Dyad Medical, Inc.
LLZ
Dec 16, 2021K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainl
Brainlab AG, DE
LLZ
Dec 15, 2021K211114Will3D
Hdx Will Corp., KR
LLZ
Dec 15, 2021K211039BIT-Motion
Dde Mri Solutions, Ltd., IL
LLZ
Dec 10, 2021K212137X-Clever
Lg Electronics.Inc, KR
LLZ
Dec 10, 2021K203743EXA
Konica Minolta Healthcare Americas, Inc.
LLZ
Dec 3, 2021K210916PVmed Contouring Software
Perception Vision Medical Technologies Ltd.Co., CN
LLZ
Dec 3, 2021K210241ImplaStation
Prodigident, Inc.
LLZ
Nov 23, 2021K211432Myomics Q
Phantomics, Inc., KR
LLZ
Nov 12, 2021K212984MiPACS HTML5 Web Viewer
Lead Technologies, Inc.
LLZ
Nov 12, 2021K212621MAMMOVISTA B.smart
Siemens Medical Solutions USA, Inc.
LLZ
Nov 12, 2021K211876Intellijoint VIEW
Intellijoint Surgical, Inc., CA
LLZ
Nov 10, 2021K212887RTapp
Segana, Inc.
LLZ
Nov 10, 2021K210344inVisionOS
Precisionos Technology, Inc., CA
LLZ
Nov 8, 2021K212550Hura CTP v1.0
Hura Imaging, Inc.
LLZ
Nov 8, 2021K211356GIQuant
Motilent, Ltd., GB
LLZ
Nov 5, 2021K212896Visible Patient Suite
Visible Patient, Sas, FR
LLZ
Nov 2, 2021K213326VisionX 3.0
Durr Dental SE, DE
LLZ
Oct 29, 2021K211987ATEC Alignment App
Alphatec Spine, Inc.
LLZ
Oct 22, 2021K210807FlightPlan for Liver
GE Medical Systems SCS, FR
LLZ
Oct 20, 2021K212470iRAD
Claritas Healthtech Pte, Ltd., SG
LLZ
Oct 18, 2021K212528Change Healthcare Cardiology
Change Healthcare Israel , Ltd., IL
LLZ
Oct 14, 2021K210999SwiftMR
Airs Medical, Inc., KR
LLZ
Oct 14, 2021K202808Brainance MD
Advantis Medical Imaging Single Member P.C., GR
LLZ
Oct 5, 2021K211429NAVIPLAN - CT Planning Software for Total Hip Replacement
Naviswiss AG, CH
LLZ
Oct 4, 2021K211795EzDent-i/ E2/ Prora View/ Smart M Viewer
Ewoosoft Co., Ltd., KR
LLZ
Sep 29, 2021K210726ImmersiveTouch
Immersivetouch, Inc.
LLZ
Sep 28, 2021K211700EzDent Web
Ewoosoft Co., Ltd., KR
LLZ
Sep 24, 2021K212777Collaboration Live
Philips Ultrasound, Inc.
LLZ
Sep 23, 2021K212321JiveX (Model Number / Release: 5.3)
Visus Health IT GmbH, DE
LLZ
Sep 13, 2021K212685KONICAMINOLTA DI-X1
Konica Minolta, Inc., JP
LLZ

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