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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
Aug 27, 2024K241684Overjet Charting Assist
Overjet, Inc.
QIH
Aug 22, 2024K241098NeuroQuant
Cortechs Labs, Inc.
QIH
Aug 16, 2024K240740qCT LN Quant
Qure.Ai Technologies, IN
QIH
Aug 15, 2024K241211CoLumbo
Smart Soft Healthcare, BG
QIH
Aug 12, 2024K242054OptimMRI (v2)
Rebrain, Sas, FR
QIH
Aug 8, 2024K233822i2Contour
Mrimath, LLC
QIH
Aug 5, 2024K240953AI Platform 2.0 (AIP002)
Exo Imaging
QIH
Jul 12, 2024K234009Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
Mighty Oak Medical
QIH
Jul 12, 2024K233457RUS
Hutom, Inc., KR
QIH
Jul 11, 2024K241329SubtleSYNTH (1.x)
Subtle Medical, Inc.
QIH
Jul 2, 2024K240736SMART Bun-Yo-Matic X-Ray
Disior, Ltd., FI
QIH
Jun 25, 2024K240582VEA Align; spineEOS
Eos Imaging, FR
QIH
Jun 21, 2024K233196Medihub Prostate
JLK, Inc., KR
QIH
Jun 20, 2024K240642SMART Bun-Yo-Matic CT
Disior, Ltd., FI
QIH
Jun 14, 2024K241083SIS System
Surgical Information Sciences, Inc.
QIH
Jun 13, 2024K233925Relu Creator
Relu BV, BE
QIH
Jun 7, 2024K241038Cardiac CT Function Software Application
Circle Cardiovascular Imaging, CA
QIH
Jun 7, 2024K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
Ever Fortune.Ai, Co., Ltd., TW
QIH
May 24, 2024K240769LVivo IQS
Dia Imaging Analysis, Ltd., IL
QIH
May 17, 2024K233209uOmnispace.CT
Shanghai United Imaging Healthcare Co., Ltd., CN
QIH
May 15, 2024K241112BriefCase-Quantification
Aidoc Medical , Ltd., IL
QIH
Apr 25, 2024K232331InVision Precision LVEF (LVEF)
InVision Medical Technology Corporation
QIH
Apr 17, 2024K233186uOmnispace.MR
Shanghai United Imaging Healthcare Co., Ltd., CN
QIH
Apr 4, 2024K240172Preview Shoulder
Genesis Software Innovations
QIH
Apr 1, 2024K233676Us2.v2
Eko.Ai Pte Ltd. D/B/A Us2.Ai, SG
QIH
Mar 29, 2024K233211AVIEW CAC
Coreline Soft Co., Ltd., KR
QIH
Mar 1, 2024K233030BoneMRI
Mriguidance B.V., NL
QIH
Mar 1, 2024K231690iCAS-LV
Highrad , Ltd., IL
QIH
Feb 29, 2024K231683inHEART Models
Inheart, Sas, FR
QIH
Feb 28, 2024K232613CT Cardiomegaly
Innolitics, LLC
QIH
Feb 23, 2024K233590Overjet Charting Assist
Overjet, Inc.
QIH
Feb 5, 2024K232363Viz HDS, Viz Volume Plus, Viz ICH+
Viz. Ai, Inc.
QIH
Jan 18, 2024K232698NemoScan
Software Nemotec S.L., ES
QIH
Jan 16, 2024K233512Rapid (6.0)
Ischemaview, Inc.
QIH
Jan 8, 2024K231324DASI Dimensions (V1.0)
Dasi Simulations
QIH
Jan 5, 2024K231917VEA Align
Eos Imaging, FR
QIH
Dec 26, 2023K231130TumorSight Viz
SimBioSys, Inc.
QIH
Dec 18, 2023K231929iQ-solutions
Sydney Neuroimaging Analysis Centre Pty, Ltd., AU
QIH
Dec 13, 2023K232231QP-Brain®
Quibim S.L., ES
QIH
Dec 11, 2023K232096Transpara Density 1.0.0
Screenpoint Medical B.V., NL
QIH
Dec 8, 2023K223757Bonelogic
Disior, Ltd., FI
QIH
Dec 5, 2023K233568Ceevra Reveal 3+
Ceevra, Inc.
QIH
Dec 5, 2023K232440Adravision Perio
Adra Corporation
QIH
Dec 1, 2023K232856Syngo Carbon Clinicals
Siemens Healthcare GmbH, DE
QIH
Nov 28, 2023K232000syngo.via MI Workflows; Scenium; syngo MBF
Siemens Medical Solutions USA, Inc.
QIH
Nov 17, 2023K232501AI Platform (AIP001)
Exo, Inc.
QIH
Nov 15, 2023K232841Axial3D Insight
Axial Medical Printing Limited, GB
QIH
Nov 13, 2023K232257Clarius Bladder AI
Clarius Mobile Health Corp., CA
QIH
Nov 13, 2023K232083BriefCase-Quantification
Aidoc Medical , Ltd., IL
QIH
Nov 8, 2023K230534BriefCase-Quantification
Aidoc Medical , Ltd., IL
QIH

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