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
Jan 6, 2023K222577TECHFIT Diagnostic Models
Techfit Digital Surgery, Inc.
LLZ
Jan 4, 2023K213263OnyxCeph
Image Instruments GmbH, DE
LLZ
Dec 30, 2022K222767PeekMed web (v1)
Peek Health, S.A., PT
LLZ
Dec 30, 2022K222195aprevo® Digital Workflow
Carlsmed, Inc.
LLZ
Dec 30, 2022K221796Cyware 4H and Cysart 4H
Abys Medical, FR
LLZ
Dec 23, 2022K223071Xenoview VDP
Polarean, Inc.
LLZ
Dec 6, 2022K222320MedDream
Softneta Uab, LT
LLZ
Nov 28, 2022K220630TorchTM Software
Voximetry, Incorporated
LLZ
Nov 25, 2022K213215VSI HoloMedicine
Apoqlar GmbH, DE
LLZ
Nov 22, 2022K223152Vision 2, EVARVision, TrackVision 2, HeartVision 2
GE Medical Systems SCS, FR
LLZ
Nov 22, 2022K222054Denti.AI Auto-Chart
Denti.Ai Technology, Inc., CA
LLZ
Nov 22, 2022K221499Minimally Invasive Prostate Surgery Navigation System
Augment Intelligent Medical System (China) Co., Ltd., CN
LLZ
Nov 22, 2022K220663AccuCTP
ArteryFlow Technology Co., Ltd., CN
LLZ
Nov 17, 2022K222476OmegaAI Image Viewer
Ramsoft, Inc., CA
LLZ
Nov 10, 2022K221677Synapse 3D Base Tools v6.6
Fujifilm Corporation, JP
LLZ
Nov 1, 2022K221478Dolphin Blue Imaging
Patterson Dental Supply, Inc.
LLZ
Oct 25, 2022K2224703Dicom MD
Singular Health Pty, Ltd., AU
LLZ
Oct 21, 2022K213128IntraOp VSP Software Device
Xironetic, LLC
LLZ
Oct 14, 2022K222662Vitrea CT Cardiac Analysis
Canon Medical Informatics, Inc.
LLZ
Oct 14, 2022K221501syngo.via View&GO
Siemens Healthcare GmbH, DE
LLZ
Sep 30, 2022K220758e-Ortho Shoulder Software v1.1
FH Industrie, FR
LLZ
Sep 6, 2022K222069Ez3D-i/E3
Ewoosoft Co., Ltd., KR
LLZ
Aug 19, 2022K213520AXIR-CX
Radisen Co., Ltd., KR
LLZ
Aug 17, 2022K220903WebCeph
Assemblecircle Corp., KR
LLZ
Aug 16, 2022K220433syngo Application Software (VE21)
Siemens Medical Solution USA, Inc.
LLZ
Aug 12, 2022K222145EzDent-i / E2 / Prora View/ Smart M Viewer
Ewoosoft Co., Ltd., KR
LLZ
Aug 12, 2022K220349TeraRecon Neuro
Terarecon,Inc.
LLZ
Aug 8, 2022K222072Dolphin Imaging 12.0
Patterson Dental Supply, Inc.
LLZ
Aug 5, 2022K221405Neurophet SCALE PET
Neurophet., Inc., KR
LLZ
Jul 22, 2022K220624AI4CMR v1.0
Ai4medimaging Medical Solutions S.A., PT
LLZ
Jul 22, 2022K213922FX SPS
Pixee Medical, FR
LLZ
Jul 20, 2022K220039AutoSeg
Ai Medic, Inc., KR
LLZ
Jul 6, 2022K221426Functional MR V1.0
Olea Medical S.A.S., FR
LLZ
Jun 23, 2022K221511Axial3D Cloud Segmentation Service
Axial Medical Printing Limited, GB
LLZ
Jun 21, 2022K213665Syngo Carbon Space VA20A
Siemens Healthcare GmbH, DE
LLZ
Jun 17, 2022K221463ElucidVivo A.3
Elucid Bioimaging, Inc.
LLZ
Jun 15, 2022K213684SurgiCase Viewer
Materialise NV, BE
LLZ
Jun 10, 2022K221065MediLab
Sigma Scientific Services, LLC
LLZ
Jun 3, 2022K2202053D Anatomic Models
Ricoh USA, Inc.
LLZ
May 31, 2022K221270EchoNavigator R4.0
Philips Medical Systems Nederland B.V., NL
LLZ
May 25, 2022K220416SwiftMR
Airs Medical, Inc., KR
LLZ
May 23, 2022K221000ON3D
3D Ons, Inc., KR
LLZ
May 20, 2022K220832syngo Dynamics (Version VA40E)
Siemens Medical Solutions USA, Inc.
LLZ
May 19, 2022K212565CoverScan v1
Perspectum, Ltd., GB
LLZ
May 16, 2022K212376Caas Qardia
Pie Medical Imaging BV, NL
LLZ
May 13, 2022K221106Quantib Prostate
Quantib B.V., NL
LLZ
May 10, 2022K220727inHEART MODELS
Inheart, Sas, FR
LLZ
May 6, 2022K213975KEOPS Balance Analyzer 3D
S.M.A.I.O, FR
LLZ
May 6, 2022K211966Segment 3DPrint
Medviso AB, SE
LLZ
May 3, 2022K213302exoplan
Exocad GmbH, DE
LLZ

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