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Panels › Radiology › Product code QIH · Class 2

Automated Radiological Image Processing Software

Regulation 892.2050

90510(k)s in 12 months (338 all time)
1recalls in 12 months (2 all time)
2recalls that name a 510(k)
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Top companies in QIH

Company510(k)sRecalls
Siemens Medical Solutions U.S.A.140
Dia Imaging Analysis, Ltd.100
Ischemaview, Inc.60
Shanghai United Imaging Healthcare Co., Ltd.60
Clarius Mobile Health Corp.50
Overjet, Inc.50
Siemens Healthcare GmbH50
Aidoc Medical , Ltd.40
Ceevra, Inc.40
Circle Cardiovascular Imaging40
Decided510(k)Device and applicantCode
Nov 3, 2023K231955aprevo® Digital Segmentation
Carlsmed, Inc.
QIH
Oct 23, 2023K232305AI-Rad Companion Brain MR
Siemens Medical Solutions U.S.A.
QIH
Oct 20, 2023K230209Sonix Health
Ontact Health Co., Ltd., KR
QIH
Oct 5, 2023K232367cmAngio® V1.0
Curemetrix, Inc.
QIH
Oct 4, 2023K231398VUNO Med-DeepBrain
Vuno, Inc., KR
QIH
Sep 29, 2023K230045HipCheck
Stryker Corp.
QIH
Sep 22, 2023K231149qXR-CTR
Qure.Ai Technologies, IN
QIH
Sep 8, 2023K223621DeepXray
Alpha Intelligence Manifolds, Inc., TW
QIH
Jul 25, 2023K230913ANDI
Imeka Solutions, Inc., CA
QIH
Jul 21, 2023K230150OptimMRI
Rebrain, Sas, FR
QIH
Jul 20, 2023K230039uOmnispace
Shanghai United Imaging Healthcare Co., Ltd., CN
QIH
Jul 14, 2023K231757Ez3D-i /E3
Ewoosoft Co., Ltd., KR
QIH
Jul 14, 2023K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image F
Brainlab AG, DE
QIH
Jul 7, 2023K231668Spine CAMP™ (1.1)
Medical Metrics, Inc.
QIH
Jul 3, 2023K222745Axial3D Insight
Axial Medical Printing Limited, GB
QIH
Jun 22, 2023K230497Bladder AI (AIBV01)
Exo, Inc.
QIH
Jun 16, 2023K223646IB Lab LAMA
Ib Lab GmbH, AT
QIH
Jun 16, 2023K223556DeepCatch
Medical IP Co., Ltd., KR
QIH
Jun 6, 2023K223855FEops HEARTguideTM, FEops HEARTguideTM ALPACA
Feops NV, BE
QIH
May 2, 2023K230977SIS System
Surgical Information Sciences, Inc.
QIH
Apr 25, 2023K222676Ceevra Reveal 3
Ceevra, Inc.
QIH
Apr 21, 2023K223501ViewFinder Software Version 1.1
Elaitra, Ltd., GB
QIH
Apr 13, 2023K213986CerebralGo Plus
Yukun (Beijing) Technology Co., Ltd., CN
QIH
Mar 31, 2023K213272Formus Hip
Formus Labs, Ltd., NZ
QIH
Mar 28, 2023K222174RadioLens v1.0
Synapsica
QIH
Mar 22, 2023K222036MPXA-2000
Medipixel, Inc., KR
QIH
Feb 22, 2023K230197BoneMRI v1.6
Mriguidance B.V., NL
QIH
Feb 6, 2023K223296Videa Perio Assist
Videahealth, Inc.
QIH
Feb 1, 2023K223396Rapid RV/LV
Ischemaview, Inc.
QIH
Feb 1, 2023K222970LVivo IQS
Dia Imaging Analysis, Ltd., IL
QIH
Jan 23, 2023K222406Clarius AI
Clarius Mobile Health Corp., CA
QIH
Dec 23, 2022K214036AVIEW
Coreline Soft Co., Ltd., KR
QIH
Dec 16, 2022K223268BrainInsight
Hyperfine, Inc.
QIH
Dec 16, 2022K222275Saige-Density
DeepHealth, Inc.
QIH
Nov 21, 2022K223032SIS System (Version 5.6.0)
Surgical Information Sciences, Inc.
QIH
Nov 16, 2022K221762BoneMRI v1.4
Mrlguidance B.V., NL
QIH
Nov 14, 2022K222428Syngo Dynamics (Version VA40F)
Siemens Medical Solutions USA, Inc.
QIH
Oct 18, 2022K221632Spine CAMP™
Medical Metrics, Inc.
QIH
Sep 30, 2022K211611QIR Suite
Casis Cardiac Simulation & Imaging Software, FR
QIH
Sep 27, 2022K221738NS-HGlio
Neosoma, Inc.
QIH
Aug 29, 2022K221100Viz RV/LV
Viz. Ai, Inc.
QIH
Aug 19, 2022K222172MI View&GO
Siemens Medical Solutions USA, Inc.
QIH
Aug 8, 2022K213645ClearPoint Maestro Brain Model
ClearPoint Neuro, Inc.
QIH
Aug 3, 2022K221432Customize
3D-Side S.A., BE
QIH
Jul 28, 2022K213998cvi42 Auto Imaging Software Application
Circle Cardiovascular Imaging, Inc., CA
QIH
Jul 22, 2022K220940EchoPAC Software Only, EchoPAC Plug-in
GE Medical Systems Ultrasound and Primary Care Diagnostics
QIH
Jul 20, 2022K220956Libby Echo:Prio
Dyad Medical, Inc.
QIH
Jul 19, 2022K220815BrainInsight
Hyperfine, Inc.
QIH
Jun 23, 2022K220497CoLumbo
Smart Soft Healthcare AD, BG
QIH
Apr 15, 2022K213706AI-Rad Companion Brain MR
Siemens Healthcare GmbH
QIH

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