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
Jun 30, 2023K213253Pixyl.Neuro
Pixyl SA, FR
LLZ
Jun 23, 2023K223048Medisystem Pacs
Medilab Manutencao E Sitemas Ltda, BR
LLZ
Jun 9, 2023K223091CT Perfusion V1.0
Olea Medical, FR
LLZ
Jun 7, 2023K231360Ambra PACS
Dicom Grid Dba Ambra Health
LLZ
Jun 6, 2023K223532Olea S.I.A. Neurovascular V1.0
Olea Medical, FR
LLZ
Jun 1, 2023K223555Brainomix 360 e-CTP
Brainomix Limited, GB
LLZ
May 30, 2023K223841KBA3D
S.M.A.I.O, FR
LLZ
May 30, 2023K222359Quicktome Software Suite
Omniscient Neurotechnology Pty Ltd (O8t), AU
LLZ
May 26, 2023K230044Pre-Sure
Lazarus 3D
LLZ
May 24, 2023K222035Avatar Medical Software V1
Avatar Medical, FR
LLZ
May 23, 2023K231162ROSA Hip System
Orthosoft Inc (D/B/A Zimmer Cas), CA
LLZ
May 23, 2023K230803ADAS 3D
Adas3D Medical S.L., ES
LLZ
May 19, 2023K212758Autoplaque
Cedars-Sinai Medical Center: Aim
LLZ
May 12, 2023K222854iTFlow
Cardio Flow Design, Inc., JP
LLZ
May 11, 2023K223623SubtleMR (2.3.x)
Subtle Medical, Inc.
LLZ
May 10, 2023K222987Akunah REFLECT
Akunah Pty, Ltd., AU
LLZ
May 10, 2023K220437Neurophet AQUA
Neurophet., Inc., KR
LLZ
May 2, 2023K2301193D Anatomic Model
Ricoh USA, Inc.
LLZ
May 1, 2023K221870CarnaLife Holo
Medapp S.A., PL
LLZ
Apr 26, 2023K230552MR DWI/FLAIR Measurement V1.0
Olea Medical, FR
LLZ
Apr 25, 2023K230906Konicaminolta DI-X1
Konica Minolta, Inc., JP
LLZ
Apr 21, 2023K230468EzDent Web
Ewoosoft Co., Ltd., KR
LLZ
Apr 17, 2023K230772Quantib Prostate
Quantib B.V., NL
LLZ
Apr 13, 2023K230393UniCam Evo Software
Inter Medical Medizintechnik GmbH, DE
LLZ
Apr 13, 2023K230264Ezra Flash
Ezra Ai, Inc.
LLZ
Apr 11, 2023K222781Augmento
Deeptek Medical Imaging Private Limited, IN
LLZ
Apr 7, 2023K230575Limbus Contour
Limbus Ai, Inc., CA
LLZ
Mar 31, 2023K213660RadAlly
Imaging Wave, LLC
LLZ
Mar 31, 2023K211059CereFlow™ V1.2
Translational Mri, LLC
LLZ
Mar 29, 2023K221984InterView XP; InterView FUSION
Mediso Medical Imaging Systems, Lttd., HU
LLZ
Mar 21, 2023K230561Syngo Carbon Space VA30A
Siemens Healthcare GmbH, DE
LLZ
Mar 21, 2023K223490FlightPlan for Embolization
GE Medical Systems SCS, FR
LLZ
Mar 3, 2023K230294CoverScan (CoverScan v1.1)
Perspectum, GB
LLZ
Mar 1, 2023K222975Advantis Platform
Advantis Medical Imaging Single Member P.C., GR
LLZ
Mar 1, 2023K221680Xeleris V Processing and Review System
GE Healthcare, IL
LLZ
Feb 24, 2023K222757Clarus Viewer
Clarus Viewer Corporation
LLZ
Feb 24, 2023K213891RealNow
Yiwei Medical Technology Co., Ltd., CN
LLZ
Feb 17, 2023K223820EzDent-i / E2 / Prora View/ Smart M Viewer
Ewoosoft Co., Ltd., KR
LLZ
Feb 13, 2023K230196syngo.via View&GO VA40A
Siemens Healthcare GmbH, DE
LLZ
Feb 10, 2023K223425MD.ai Viewer
Mdai, Inc.
LLZ
Feb 2, 2023K230012Atomica Planner
Atomica Technology, Inc.
LLZ
Jan 20, 2023K221725Advanced MyHip Planner
Medacta International S.A., CH
LLZ
Jan 19, 2023K221627PerfusionGo Plus
Yukun (Beijing) Technology Co., Ltd., CN
LLZ
Jan 18, 2023K222593TruPlan Computed Tomography (CT) Imaging Software
Circle Cardiovascular Imaging, Inc., CA
LLZ
Jan 17, 2023K223800MIM – Additional Tracers
Mim Software, Inc.
LLZ
Jan 17, 2023K220649Elucis
Realize Medical, Inc., CA
LLZ
Jan 13, 2023K223502MR Diffusion Perfusion Mismatch V1.0
Olea Medical, FR
LLZ
Jan 12, 2023K223363MAMMOVISTA B.smart (VB70)
Siemens Medical Solutions USA, Inc.
LLZ
Jan 12, 2023K222458AIBOLIT 3D+
Aibolit Technologies, LLC
LLZ
Jan 9, 2023K223336Vitrea Software Package, VSTP-002A
Canon Medical Systems Corporation, JP
LLZ

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