Product Code: QIH
FDA class 2
21 CFR 892.2050
Automated Radiological Image Processing Software
Radiology
Automated Radiological Image Processing Software is a Class 2 software device implementing artificial intelligence, including nonadaptive machine learning algorithms trained on clinical or artificial data, intended to provide automated radiological image processing and analysis tools. Adaptive AI algorithms are explicitly excluded from this product code's scope. It requires 510(k) clearance and is regulated under 21 CFR 892.2050 within the Radiology medical specialty. The product code is QIH. The device is not an implant and is not flagged as life-sustaining.
510(k)s
304
FEI Numbers
217
Registration Numbers
217
Unique Applicants
175
Years Active
7
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Basic Information
- Product Code
- QIH
- Device Class
- FDA class 2
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 304 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K261713 | Synapse PACS (7.6.0) | Jun 18, 2026 | Substantially Equivalent | FUJIFILM Healthcare Americas Corporation |
| K260300 | WatchMate Software | Jun 15, 2026 | Substantially Equivalent | Anumana, Inc. |
| K253690 | LungMaps | Jun 15, 2026 | Substantially Equivalent | Siemens Healthineers AG |
| K253172 | MediAI-OA | Jun 15, 2026 | Substantially Equivalent | Crescom Co., Ltd. |
| K260406 | Brainomix 360 Hyperdensity | Jun 12, 2026 | Substantially Equivalent | Brainomix Limited |
| K260322 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Jun 11, 2026 | Substantially Equivalent | Mighty Oak Medical |
| K260497 | DEEPVESSEL Plaque | Jun 04, 2026 | Substantially Equivalent | Keya Medical Technology Co., Ltd. |
| K260077 | OrthoGrid Hip AI® 4.0 | May 29, 2026 | Substantially Equivalent | OrthoGrid Systems, Inc. |
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| K260324 | Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning | May 22, 2026 | Substantially Equivalent | Canon Medical Informatics, Inc. |
| K260234 | MSK Go | May 21, 2026 | Substantially Equivalent | Smart Alfa Teknoloji San. Ve Tic. A.S. |
| K254131 | BAC | May 21, 2026 | Substantially Equivalent | DeepHealth, Inc. |
| K261289 | UNiD Spine Analyzer (SW3002) | May 15, 2026 | Substantially Equivalent | Medicrea International S.A.S. (Medtronic) |
| K261273 | Neurophet AQUA | May 15, 2026 | Substantially Equivalent | Neurophet., Inc. |
| K254120 | SubtleHD-CT (1.x) | May 15, 2026 | Substantially Equivalent | Subtle Medical, Inc. |
| K252563 | Neurophet SCALE PET | May 15, 2026 | Substantially Equivalent | Neurophet., Inc. |
| K260032 | Morph | May 13, 2026 | Substantially Equivalent | BeauBrain Healthcare, Inc. |
| K254189 | Synapse 3D Base Tools (V7.2) | Apr 30, 2026 | Substantially Equivalent | Fujifilm Corporation |
| K254184 | syngo Application Software | Apr 29, 2026 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K260785 | DS Core CBCT Anatomy | Apr 23, 2026 | Substantially Equivalent | Dentsply Sirona |
| K253077 | uOmnispace.MR | Apr 22, 2026 | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. |
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| K253502 | Critical Care Suite with Enteric Tube Positioning AI Algorithm | Apr 14, 2026 | Substantially Equivalent | Ge Medical Systems, LLC |
| K253930 | Overjet Iris Intelligent Imaging System | Apr 10, 2026 | Substantially Equivalent | Overjet, Inc. |
| K253689 | syngo Dynamics (VA41F) | Apr 10, 2026 | Substantially Equivalent | Siemens Healthcare GmbH |
| K252708 | Relu Cloud | Apr 10, 2026 | Substantially Equivalent | Relu BV |
| K254015 | CoLumbo C-Spine | Apr 01, 2026 | Substantially Equivalent | Smart Soft Healthcare AD |
| K254207 | AiORTA - Plan v2.0 | Mar 30, 2026 | Substantially Equivalent | ViTAA Medical Solutions, Inc. |
| K253775 | SwiftMR | Mar 26, 2026 | Substantially Equivalent | Airs Medical, Inc. |
| K253614 | EchoNavigator R5.0 | Mar 17, 2026 | Substantially Equivalent | Philips Medical Systems Nederland B.V. |
| K253944 | Data Analysis Facilitation Suite (DAFS) | Mar 16, 2026 | Substantially Equivalent | Voronoi Health Analytics Incorporated |
| K252261 | InferCare RECIST | Mar 13, 2026 | Substantially Equivalent | Beijing Infervision Healthcare Medical Technology Co., Ltd. |
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| K252538 | CEPHX3D | Mar 05, 2026 | Substantially Equivalent | Orca Dental AI , Ltd. |
| K253593 | Clarius Ejection Fraction AI | Mar 02, 2026 | Substantially Equivalent | Clarius Mobile Health Corp. |
| K253535 | Ligence Heart | Feb 27, 2026 | Substantially Equivalent | Ligence Uab |
| K260217 | AI Platform 2.2 (AIP002) | Feb 24, 2026 | Substantially Equivalent | Exo Imaging |
| K252084 | AI4CMR v2.0 | Feb 11, 2026 | Substantially Equivalent | Ai4medimaging Medical Solutions S.A. |
| K254016 | MI View&GO | Feb 10, 2026 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K252496 | Neurophet AQUA AD Plus | Jan 29, 2026 | Substantially Equivalent | Neurophet., Inc. |
| K252091 | Surgical Reality Viewer | Jan 29, 2026 | Substantially Equivalent | Medicalvr B.V. |
| K253735 | AV Vascular | Jan 22, 2026 | Substantially Equivalent | Philips Medical Systems Nederland B.V. |
| K253057 | AI-Rad Companion Brain MR | Jan 22, 2026 | Substantially Equivalent | Siemens Healthcare GmbH |
| K252634 | Imagine® Enterprise Suite | Jan 16, 2026 | Substantially Equivalent | Softlink International Private Limited |
| K253532 | TruSPECT Processing Station | Dec 30, 2025 | Substantially Equivalent | Spectrum Dynamics Medical, Ltd. |
| K252856 | PeekMed web | Dec 22, 2025 | Substantially Equivalent | Peek Health, S.A. |
| K252670 | Alzevita | Dec 19, 2025 | Substantially Equivalent | TOPIA MEDTECH LIMITED |
| K252029 | AI-CVD | Dec 19, 2025 | Substantially Equivalent | HeartLung Corporation |
| K252235 | PVAD IQ Software | Dec 18, 2025 | Substantially Equivalent | Ultrasight , Ltd. |
| K250914 | MediAI-BA | Dec 18, 2025 | Substantially Equivalent | Crescom Co., Ltd. |
| K252922 | Neosoma Brain Mets | Dec 17, 2025 | Substantially Equivalent | Neosoma, Inc. |
| K251763 | IRISeg | Dec 16, 2025 | Substantially Equivalent | Intuitive Surgical, Inc. |
| K251514 | Overjet CBCT Assist | Dec 05, 2025 | Substantially Equivalent | Overjet, Inc. |
| K252103 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Dec 02, 2025 | Substantially Equivalent | Mighty Oak Medical |
| K251078 | AutoDensity | Nov 14, 2025 | Substantially Equivalent | Eos Imaging |
| K252452 | PeekMed web | Nov 12, 2025 | Substantially Equivalent | Peek Health, S.A. |
| K250330 | 3mensio Workstation | Nov 03, 2025 | Substantially Equivalent | Pie Medical Imaging BV |
| K250337 | AiORTA - Plan | Oct 30, 2025 | Substantially Equivalent | ViTAA Medical Solutions, Inc. |
| K251027 | cvi42 Coronary Plaque Software Application | Oct 27, 2025 | Substantially Equivalent | Circle Cardiovascular Imaging, Inc. |
| K251059 | Syngo Carbon Clinicals (VA41) | Oct 24, 2025 | Substantially Equivalent | Siemens Healthineers AG |
| K250288 | TeraRecon Cardiovascular.Calcification.CT | Oct 23, 2025 | Substantially Equivalent | Terarecon,Inc. |
| K252298 | ANDI 2.0 | Oct 22, 2025 | Substantially Equivalent | Imeka Solutions, Inc. |
| K252665 | brAIn Shoulder Positioning | Oct 20, 2025 | Substantially Equivalent | Avatar Medical |
| K252214 | AIAS Cephalon | Oct 07, 2025 | Substantially Equivalent | Metamorphosis GmbH |
| K252007 | BlineSlide | Oct 06, 2025 | Substantially Equivalent | Deep Breathe, Inc. |
| K250023 | SMART PCFD | Sep 29, 2025 | Substantially Equivalent | Disior, Ltd. |
| K252105 | Ligence Heart | Sep 26, 2025 | Substantially Equivalent | Ligence Uab |
| K251527 | Brain WMH | Sep 25, 2025 | Substantially Equivalent | Quantib B.V. |
| K251987 | Rapid Aortic Measurements | Sep 23, 2025 | Substantially Equivalent | Ischemaview, Inc. |
| K251483 | SwiftSight-Brain | Sep 23, 2025 | Substantially Equivalent | Airs Medical, Inc. |
| K250369 | Axial3D Insight | Sep 18, 2025 | Substantially Equivalent | Axial Medical Printing Limited |
| K250237 | InferOperate Suite | Sep 15, 2025 | Substantially Equivalent | Beijing Infervision Healthcare Medical Technology Co., Ltd. |
| K244002 | AngioWaveNet | Sep 10, 2025 | Substantially Equivalent | Angiowave Imaging, Inc. |
| K251072 | Segmentron Viewer | Sep 09, 2025 | Substantially Equivalent | DGNCT, LLC |
| K251656 | Careverse CoronaryDoc (Careverse CoronaryDoc) | Sep 04, 2025 | Substantially Equivalent | Careverse Technology Pte. , Ltd. |
| K252539 | Tempus Pixel | Sep 03, 2025 | Substantially Equivalent | Arterys, Inc. |
| K243859 | PRAEVAorta®2 | Aug 29, 2025 | Substantially Equivalent | Nurea |
| K250947 | VistaSoft 4.0 and VisionX 4.0 | Aug 27, 2025 | Substantially Equivalent | Durr Dental SE |
| K252362 | GBrain MRI | Aug 22, 2025 | Substantially Equivalent | Galileo Cds, Inc. |
| K243685 | MammoScreen BD | Aug 22, 2025 | Substantially Equivalent | Therapixel |
| K251837 | Salix Coronary Plaque (V1.0.0) | Aug 20, 2025 | Substantially Equivalent | Artrya Limited |
| K251747 | VEA Align; spineEOS | Aug 15, 2025 | Substantially Equivalent | Eos Imaging |
| K250755 | DS Core Diagnosis | Aug 12, 2025 | Substantially Equivalent | Dentsply Sirona, Inc. |
| K251629 | UNiD Spine Analyzer | Aug 07, 2025 | Substantially Equivalent | Medicrea International S.A.S. (Medtronic) |
| K243919 | Voxel Dosimetry (00859873006226) | Jul 30, 2025 | Substantially Equivalent | Hermes Medical Solutions AB |
| K251342 | EchoPAC Software Only / EchoPAC Plug-in | Jul 16, 2025 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| K251096 | PeekMed web | Jul 14, 2025 | Substantially Equivalent | Peek Health, S.A. |
| K251766 | TumorSight Viz | Jul 08, 2025 | Substantially Equivalent | SimBioSys, Inc. |
| K251528 | syngo.via MI Workflows; Scenium; syngo MBF | Jul 03, 2025 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K243779 | Bunkerhill Abdominal Aortic Quantification (AAQ) | Jul 01, 2025 | Substantially Equivalent | BunkerHill Health |
| K250670 | EchoConfidence (USA) | Jun 30, 2025 | Substantially Equivalent | Mycardium AI Limited |
| K250484 | PIUR tUS inside | Jun 30, 2025 | Substantially Equivalent | Piur Imaging GmbH |
| K243647 | Synapse PACS (7.5) | Jun 30, 2025 | Substantially Equivalent | FUJIFILM Healthcare Americas Corporation |
| K243633 | Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) | Jun 13, 2025 | Substantially Equivalent | Brainlab AG |
| K250354 | Viz Subdural+, Viz SUBDURAL PLUS | Jun 10, 2025 | Substantially Equivalent | Viz. Ai, Inc. |
| K251009 | Cirrus Resting State fMRI Software | Jun 06, 2025 | Substantially Equivalent | Sora Neuroscience, Inc. |
| K251456 | BrightHeart View Classifier | Jun 05, 2025 | Substantially Equivalent | Brightheart |
| K243810 | TraumaCad Neo (1.1) | Jun 04, 2025 | Substantially Equivalent | Brainlab , Ltd. |
| K243863 | Opulus Lymphoma Precision | May 30, 2025 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| K243005 | AudaxCeph Cephalogram Analysis Software | May 30, 2025 | Substantially Equivalent | Audax D.O.O. |
| K250367 | CoLumboX | May 28, 2025 | Substantially Equivalent | Smart Soft Healthcare AD |
| K243378 | Rapid MLS | May 28, 2025 | Substantially Equivalent | Ischemaview, Inc. |
| K250005 | Clever One | May 23, 2025 | Substantially Equivalent | Ewoosoft Co., Ltd. |
| K243989 | Second Opinion® 3D | May 23, 2025 | Substantially Equivalent | Pearl, Inc. |
| K243762 | Synapse 3D Base Tools (V7.0) | May 21, 2025 | Substantially Equivalent | Fujifilm Corporation |
| K242624 | Medical Image Post-processing Software (uOmnispace.CT) | May 14, 2025 | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. |
| K243230 | Second Opinion® BLE | May 09, 2025 | Substantially Equivalent | Pearl, Inc. |
| K250226 | Clarius Median Nerve AI | May 08, 2025 | Substantially Equivalent | Clarius Mobile Health Corp. |
| K243684 | BrightHeart View Classifier | May 07, 2025 | Substantially Equivalent | Brightheart |
| K250328 | UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program | Apr 30, 2025 | Substantially Equivalent | Canon Medical Systems Corporation |
| K243853 | Clarius Prostate AI | Apr 16, 2025 | Substantially Equivalent | Clarius Mobile Health Corp. |
| K242500 | LARALAB | Apr 16, 2025 | Substantially Equivalent | Laralab GmbH |
| K250416 | GBrain MRI | Apr 11, 2025 | Substantially Equivalent | Galileo Cds, Inc. |
| K250754 | cmAngio® (V1.6) | Apr 10, 2025 | Substantially Equivalent | Curemetrix, Inc. |
| K241982 | DeepFoqus (DeepFoqus-Accelerate) | Apr 04, 2025 | Substantially Equivalent | Foqus Technologies, Inc. |
| K242551 | syngo Dynamics (Version VA41D) | Apr 03, 2025 | Substantially Equivalent | Siemens Healthcare GmbH |
| K241984 | Hi-D Imaging 4TAVR | Apr 02, 2025 | Substantially Equivalent | Hi-D Imaging AG |
| K242166 | TribusConnect | Mar 31, 2025 | Substantially Equivalent | Tribusmed Beheer BV |
| K243038 | Salix Central | Mar 27, 2025 | Substantially Equivalent | Artrya Limited |
| K241961 | Vent Creativity Knee v1.0 (Hermes) | Mar 20, 2025 | Substantially Equivalent | Vent Creativity |
| K250042 | PeekMed web | Mar 19, 2025 | Substantially Equivalent | Peek Health, S.A. |
| K243689 | AVIEW | Mar 19, 2025 | Substantially Equivalent | Coreline Soft Co., Ltd. |
| K243862 | LVivo Software Application | Mar 17, 2025 | Substantially Equivalent | Dia Imaging Analysis, Ltd. |
| K242338 | Cleerly LABS (v2.0) | Mar 07, 2025 | Substantially Equivalent | Cleerly, Inc. |
| K243331 | LVivo Seamless | Mar 06, 2025 | Substantially Equivalent | Dia Imaging Analysis, Ltd. |
| K243933 | Ceevra Reveal 3+ | Mar 04, 2025 | Substantially Equivalent | Ceevra, Inc. |
| K243235 | LVivo Software Application | Mar 03, 2025 | Substantially Equivalent | Dia Imaging Analysis, Ltd. |
| K241922 | Myomics | Feb 28, 2025 | Substantially Equivalent | Phantomics, Inc. |
| K241222 | Ventripoint Medical System Plus (VMS+) 4.0 | Feb 26, 2025 | Substantially Equivalent | Ventripoint Diagnostics , Ltd. |
| K242607 | ScanDiags Ortho L-Spine MR-Q | Feb 21, 2025 | Substantially Equivalent | Scandiags AG |
| K243696 | AVIEW CAC | Feb 14, 2025 | Substantially Equivalent | Coreline Soft Co., Ltd. |
| K243250 | SubtleHD (1.x) | Feb 12, 2025 | Substantially Equivalent | Subtle Medical, Inc. |
| K241659 | Ultrasound Workspace (UWS 6.0) | Feb 10, 2025 | Substantially Equivalent | Philips Ultrasound, LLC |
| K241593 | BoneMetrics (US) | Feb 05, 2025 | Substantially Equivalent | Gleamer Sas |
| K243158 | TeraRecon Aorta.CT (1.1.0) | Jan 23, 2025 | Substantially Equivalent | Terarecon,Inc. |
| K243350 | Rapid Neuro3D | Jan 22, 2025 | Substantially Equivalent | Ischemaview, Inc. |
| K242334 | Ezra Flash | Jan 02, 2025 | Substantially Equivalent | Ezra Ai, Inc. |
| K241696 | Ortho AI | Jan 02, 2025 | Substantially Equivalent | Ortho Ai, LLC |
| K243705 | Saige-Density (2.5.0) | Dec 19, 2024 | Substantially Equivalent | DeepHealth, Inc. |
| K242270 | OrthoNext Platform System | Dec 19, 2024 | Substantially Equivalent | Orthofix Srl |
| K240793 | MSKai | Dec 16, 2024 | Substantially Equivalent | Mskai |
| K242461 | IRISeg | Dec 10, 2024 | Substantially Equivalent | Intuitive Surgical, Inc. |
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| K240680 | CDM Insights | Dec 06, 2024 | Substantially Equivalent | Oxford Brain Diagnostics, Ltd. |
| K240645 | Sonix Health | Nov 27, 2024 | Substantially Equivalent | Ontact Health Co., Ltd. |
| K242203 | BriefCase-Quantification | Nov 22, 2024 | Substantially Equivalent | Aidoc Medical , Ltd. |
| K242359 | Strain AI (SAI001) | Nov 20, 2024 | Substantially Equivalent | Exo, Inc. |
| K241312 | TeraRecon Cardiac.Chambers.MR (1.0.0) | Nov 05, 2024 | Substantially Equivalent | Terarecon,Inc. |
| K241108 | RemedyLogic AI MRI Lumbar Spine Reader | Oct 30, 2024 | Substantially Equivalent | Remedy Logic, Inc. |
| K243189 | TumorSight Viz | Oct 25, 2024 | Substantially Equivalent | SimBioSys, Inc. |
| K242215 | Neurophet AQUA (V3.1) | Oct 25, 2024 | Substantially Equivalent | Neurophet., Inc. |
| K242781 | cvi42 Software Application | Oct 15, 2024 | Substantially Equivalent | Circle Cardiovascular Imaging, Inc. |
| K241430 | EchoMeasure | Oct 10, 2024 | Substantially Equivalent | Icardio.Ai |
| K240786 | AutoChamber | Oct 10, 2024 | Substantially Equivalent | HeartLung Corporation |
| K240553 | LVivo Software Application | Oct 04, 2024 | Substantially Equivalent | Dia Imaging Analysis, Ltd. |
| K241561 | MammoScreen BD | Oct 02, 2024 | Substantially Equivalent | Therapixel |
| K240943 | LungVision | Oct 01, 2024 | Substantially Equivalent | Bodyvision Medical , Ltd. |
| K240036 | PIUR tUS Infinity | Sep 20, 2024 | Substantially Equivalent | Piur Imaging GmbH |
| K241280 | Constellation (CON-001) | Sep 12, 2024 | Substantially Equivalent | Q Bio, Inc. |
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| K240791 | ADAS 3D | Sep 09, 2024 | Substantially Equivalent | Adas3D Medical S.L. |
| K240411 | uAI Portal | Sep 06, 2024 | Substantially Equivalent | Shanghai United Imaging Intelligence Co., Ltd. |
| K242300 | MI View&GO | Aug 30, 2024 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K242275 | syngo.via MI Workflows; Scenium; syngo MBF | Aug 30, 2024 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K241847 | Imbio PHA (4.0.0) | Aug 30, 2024 | Substantially Equivalent | Imbio, Inc. |
| K241684 | Overjet Charting Assist | Aug 27, 2024 | Substantially Equivalent | Overjet, Inc. |
| K241098 | NeuroQuant | Aug 22, 2024 | Substantially Equivalent | Cortechs Labs, Inc. |
| K240740 | qCT LN Quant | Aug 16, 2024 | Substantially Equivalent | Qure.Ai Technologies |
| K241211 | CoLumbo | Aug 15, 2024 | Substantially Equivalent | Smart Soft Healthcare |
| K242054 | OptimMRI (v2) | Aug 12, 2024 | Substantially Equivalent | Rebrain, Sas |
| K233822 | i2Contour | Aug 08, 2024 | Substantially Equivalent | Mrimath, LLC |
| K240953 | AI Platform 2.0 (AIP002) | Aug 05, 2024 | Substantially Equivalent | Exo Imaging |
| K234009 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Jul 12, 2024 | Substantially Equivalent | Mighty Oak Medical |
| K233457 | RUS | Jul 12, 2024 | Substantially Equivalent | Hutom, Inc. |
| K241329 | SubtleSYNTH (1.x) | Jul 11, 2024 | Substantially Equivalent | Subtle Medical, Inc. |
| K240736 | SMART Bun-Yo-Matic X-Ray | Jul 02, 2024 | Substantially Equivalent | Disior, Ltd. |
| K240582 | VEA Align; spineEOS | Jun 25, 2024 | Substantially Equivalent | Eos Imaging |
| K233196 | Medihub Prostate | Jun 21, 2024 | Substantially Equivalent | JLK, Inc. |
| K240642 | SMART Bun-Yo-Matic CT | Jun 20, 2024 | Substantially Equivalent | Disior, Ltd. |
| K241083 | SIS System | Jun 14, 2024 | Substantially Equivalent | Surgical Information Sciences, Inc. |
| K233925 | Relu Creator | Jun 13, 2024 | Substantially Equivalent | Relu BV |
| K241038 | Cardiac CT Function Software Application | Jun 07, 2024 | Substantially Equivalent | Circle Cardiovascular Imaging |
| K234042 | EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) | Jun 07, 2024 | Substantially Equivalent | Ever Fortune.Ai, Co., Ltd. |
| K240769 | LVivo IQS | May 24, 2024 | Substantially Equivalent | Dia Imaging Analysis, Ltd. |
| K233209 | uOmnispace.CT | May 17, 2024 | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. |
| K241112 | BriefCase-Quantification | May 15, 2024 | Substantially Equivalent | Aidoc Medical , Ltd. |
| K232331 | InVision Precision LVEF (LVEF) | Apr 25, 2024 | Substantially Equivalent | InVision Medical Technology Corporation |
| K233186 | uOmnispace.MR | Apr 17, 2024 | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. |
| K240172 | Preview Shoulder | Apr 04, 2024 | Substantially Equivalent | Genesis Software Innovations |
| K233676 | Us2.v2 | Apr 01, 2024 | Substantially Equivalent | Eko.Ai Pte Ltd. D/B/A Us2.Ai |
| K233211 | AVIEW CAC | Mar 29, 2024 | Substantially Equivalent | Coreline Soft Co., Ltd. |
| K233030 | BoneMRI | Mar 01, 2024 | Substantially Equivalent | Mriguidance B.V. |
| K231690 | iCAS-LV | Mar 01, 2024 | Substantially Equivalent | Highrad , Ltd. |
| K231683 | inHEART Models | Feb 29, 2024 | Substantially Equivalent | Inheart, Sas |
| K232613 | CT Cardiomegaly | Feb 28, 2024 | Substantially Equivalent | Innolitics, LLC |
| K233590 | Overjet Charting Assist | Feb 23, 2024 | Substantially Equivalent | Overjet, Inc. |
| K232363 | Viz HDS, Viz Volume Plus, Viz ICH+ | Feb 05, 2024 | Substantially Equivalent | Viz. Ai, Inc. |
| K232698 | NemoScan | Jan 18, 2024 | Substantially Equivalent | Software Nemotec S.L. |
| K233512 | Rapid (6.0) | Jan 16, 2024 | Substantially Equivalent | Ischemaview, Inc. |
| K231324 | DASI Dimensions (V1.0) | Jan 08, 2024 | Substantially Equivalent | Dasi Simulations |
| K231917 | VEA Align | Jan 05, 2024 | Substantially Equivalent | Eos Imaging |
| K231130 | TumorSight Viz | Dec 26, 2023 | Substantially Equivalent | SimBioSys, Inc. |
| K231929 | iQ-solutions | Dec 18, 2023 | Substantially Equivalent | Sydney Neuroimaging Analysis Centre Pty, Ltd. |
| K232231 | QP-Brain® | Dec 13, 2023 | Substantially Equivalent | Quibim S.L. |
| K232096 | Transpara Density 1.0.0 | Dec 11, 2023 | Substantially Equivalent | Screenpoint Medical B.V. |
| K223757 | Bonelogic | Dec 08, 2023 | Substantially Equivalent | Disior, Ltd. |
| K233568 | Ceevra Reveal 3+ | Dec 05, 2023 | Substantially Equivalent | Ceevra, Inc. |
| K232440 | Adravision Perio | Dec 05, 2023 | Substantially Equivalent | Adra Corporation |
| K232856 | Syngo Carbon Clinicals | Dec 01, 2023 | Substantially Equivalent | Siemens Healthcare GmbH |
| K232000 | syngo.via MI Workflows; Scenium; syngo MBF | Nov 28, 2023 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K232501 | AI Platform (AIP001) | Nov 17, 2023 | Substantially Equivalent | Exo, Inc. |
| K232841 | Axial3D Insight | Nov 15, 2023 | Substantially Equivalent | Axial Medical Printing Limited |
| K232257 | Clarius Bladder AI | Nov 13, 2023 | Substantially Equivalent | Clarius Mobile Health Corp. |
| K232083 | BriefCase-Quantification | Nov 13, 2023 | Substantially Equivalent | Aidoc Medical , Ltd. |
| K230534 | BriefCase-Quantification | Nov 08, 2023 | Substantially Equivalent | Aidoc Medical , Ltd. |
| K231955 | aprevo® Digital Segmentation | Nov 03, 2023 | Substantially Equivalent | Carlsmed, Inc. |
| K232305 | AI-Rad Companion Brain MR | Oct 23, 2023 | Substantially Equivalent | Siemens Medical Solutions U.S.A. |
| K230209 | Sonix Health | Oct 20, 2023 | Substantially Equivalent | Ontact Health Co., Ltd. |
| K232367 | cmAngio® V1.0 | Oct 05, 2023 | Substantially Equivalent | Curemetrix, Inc. |
| K231398 | VUNO Med-DeepBrain | Oct 04, 2023 | Substantially Equivalent | Vuno, Inc. |
| K230045 | HipCheck | Sep 29, 2023 | Substantially Equivalent | Stryker Corp. |
| K231149 | qXR-CTR | Sep 22, 2023 | Substantially Equivalent | Qure.Ai Technologies |
| K223621 | DeepXray | Sep 08, 2023 | Substantially Equivalent | Alpha Intelligence Manifolds, Inc. |
| K230913 | ANDI | Jul 25, 2023 | Substantially Equivalent | Imeka Solutions, Inc. |
| K230150 | OptimMRI | Jul 21, 2023 | Substantially Equivalent | Rebrain, Sas |
| K230039 | uOmnispace | Jul 20, 2023 | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. |
| K231757 | Ez3D-i /E3 | Jul 14, 2023 | Substantially Equivalent | Ewoosoft Co., Ltd. |
| K223106 | Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) | Jul 14, 2023 | Substantially Equivalent | Brainlab AG |
| K231668 | Spine CAMP (1.1) | Jul 07, 2023 | Substantially Equivalent | Medical Metrics, Inc. |
| K222745 | Axial3D Insight | Jul 03, 2023 | Substantially Equivalent | Axial Medical Printing Limited |
| K230497 | Bladder AI (AIBV01) | Jun 22, 2023 | Substantially Equivalent | Exo, Inc. |
| K223646 | IB Lab LAMA | Jun 16, 2023 | Substantially Equivalent | Ib Lab GmbH |
| K223556 | DeepCatch | Jun 16, 2023 | Substantially Equivalent | Medical IP Co., Ltd. |
| K223855 | FEops HEARTguideTM, FEops HEARTguideTM ALPACA | Jun 06, 2023 | Substantially Equivalent | Feops NV |
| K230977 | SIS System | May 02, 2023 | Substantially Equivalent | Surgical Information Sciences, Inc. |
| K222676 | Ceevra Reveal 3 | Apr 25, 2023 | Substantially Equivalent | Ceevra, Inc. |
| K223501 | ViewFinder Software Version 1.1 | Apr 21, 2023 | Substantially Equivalent | Elaitra, Ltd. |
| K213986 | CerebralGo Plus | Apr 13, 2023 | Substantially Equivalent | Yukun (Beijing) Technology Co., Ltd. |
| K213272 | Formus Hip | Mar 31, 2023 | Substantially Equivalent | Formus Labs, Ltd. |
| K222174 | RadioLens v1.0 | Mar 28, 2023 | Substantially Equivalent | Synapsica |
| K222036 | MPXA-2000 | Mar 22, 2023 | Substantially Equivalent | Medipixel, Inc. |
| K230197 | BoneMRI v1.6 | Feb 22, 2023 | Substantially Equivalent | Mriguidance B.V. |
| K223296 | Videa Perio Assist | Feb 06, 2023 | Substantially Equivalent | Videahealth, Inc. |
| K223396 | Rapid RV/LV | Feb 01, 2023 | Substantially Equivalent | Ischemaview, Inc. |
| K222970 | LVivo IQS | Feb 01, 2023 | Substantially Equivalent | Dia Imaging Analysis, Ltd. |
| K222406 | Clarius AI | Jan 23, 2023 | Substantially Equivalent | Clarius Mobile Health Corp. |
| K214036 | AVIEW | Dec 23, 2022 | Substantially Equivalent | Coreline Soft Co., Ltd. |
| K223268 | BrainInsight | Dec 16, 2022 | Substantially Equivalent | Hyperfine, Inc. |
| K222275 | Saige-Density | Dec 16, 2022 | Substantially Equivalent | DeepHealth, Inc. |
| K223032 | SIS System (Version 5.6.0) | Nov 21, 2022 | Substantially Equivalent | Surgical Information Sciences, Inc. |
| K221762 | BoneMRI v1.4 | Nov 16, 2022 | Substantially Equivalent | Mrlguidance B.V. |
| K222428 | Syngo Dynamics (Version VA40F) | Nov 14, 2022 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K221632 | Spine CAMP | Oct 18, 2022 | Substantially Equivalent | Medical Metrics, Inc. |
| K211611 | QIR Suite | Sep 30, 2022 | Substantially Equivalent | Casis Cardiac Simulation & Imaging Software |
| K221738 | NS-HGlio | Sep 27, 2022 | Substantially Equivalent | Neosoma, Inc. |
| K221100 | Viz RV/LV | Aug 29, 2022 | Substantially Equivalent | Viz. Ai, Inc. |
| K222172 | MI View&GO | Aug 19, 2022 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K213645 | ClearPoint Maestro Brain Model | Aug 08, 2022 | Substantially Equivalent | ClearPoint Neuro, Inc. |
| K221432 | Customize | Aug 03, 2022 | Substantially Equivalent | 3D-Side S.A. |
| K213998 | cvi42 Auto Imaging Software Application | Jul 28, 2022 | Substantially Equivalent | Circle Cardiovascular Imaging, Inc. |
| K220940 | EchoPAC Software Only, EchoPAC Plug-in | Jul 22, 2022 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| K220956 | Libby Echo:Prio | Jul 20, 2022 | Substantially Equivalent | Dyad Medical, Inc. |
| K220815 | BrainInsight | Jul 19, 2022 | Substantially Equivalent | Hyperfine, Inc. |
| K220497 | CoLumbo | Jun 23, 2022 | Substantially Equivalent | Smart Soft Healthcare AD |
| K213706 | AI-Rad Companion Brain MR | Apr 15, 2022 | Substantially Equivalent | Siemens Healthcare GmbH |
| K212624 | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System | Apr 04, 2022 | Substantially Equivalent | Ever Fortune.Ai, Co., Ltd. |
| K213779 | Customize | Mar 16, 2022 | Substantially Equivalent | 3D-Side S.A. |
| K203744 | Arterys MICA | Mar 14, 2022 | Substantially Equivalent | Arterys, Inc. |
| K212012 | Follicle Clarity | Jan 19, 2022 | Substantially Equivalent | Cycle Clarity |
| K210747 | Caption Interpretation Automated Ejection Fraction Software | Jan 19, 2022 | Substantially Equivalent | Caption Health |
| K213544 | TOMTEC-ARENA | Jan 06, 2022 | Substantially Equivalent | Tomtec Imaging Systems GmbH |
| K202404 | BoneMRI | Dec 22, 2021 | Substantially Equivalent | Mriguidance B.V. |
| K212690 | qXR-BT | Dec 21, 2021 | Substantially Equivalent | Qure.Ai Technologies |
| K213275 | EchoGo Core (2.0) | Dec 20, 2021 | Substantially Equivalent | Ultromics Limited |
| K212466 | LVivo Seamless | Dec 09, 2021 | Substantially Equivalent | Dia Imaging Analysis, Ltd. |
| K210831 | OnQ Neuro | Nov 19, 2021 | Substantially Equivalent | Cortechs Labs, Inc. |
| K211161 | Critical Care Suite with Endotracheal Tube Positing AI algorithm | Oct 29, 2021 | Substantially Equivalent | Ge Medical Systems, LLC |
| K203785 | ClariSIGMAM | Sep 10, 2021 | Substantially Equivalent | Claripi, Inc. |
| K203555 | AmCAD-UT | Sep 08, 2021 | Substantially Equivalent | Amcad Biomed Corporation |
| K211431 | breastscape v1.0 | Aug 02, 2021 | Substantially Equivalent | Olea Medical |
| K211222 | qER-Quant | Jul 30, 2021 | Substantially Equivalent | Qure.Ai Technologies |
| K210791 | Us2.v1 | Jul 27, 2021 | Substantially Equivalent | Eko.Ai Pte Ltd. D/B/A Us2.Ai |
| K210719 | Change Healthcare Anatomical AI | Jul 20, 2021 | Substantially Equivalent | Change Healthcare Canada Company |
| K211506 | PowerLook Density Assessment V4.0 | Jul 12, 2021 | Substantially Equivalent | Icad, Inc. |
| K211459 | syngo.via MI WorkFlows, Scenium, syngo MBF | Jun 10, 2021 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K203502 | MEDO-Thyroid | Apr 23, 2021 | Substantially Equivalent | Medo DX Pte. , Ltd. |
| K210556 | Preview Shoulder | Apr 21, 2021 | Substantially Equivalent | Genesis Software Innovations |
| K203256 | Imbio RV/LV Software | Mar 09, 2021 | Substantially Equivalent | Imbio, LLC |
| K210053 | LVivo Software Application | Feb 05, 2021 | Substantially Equivalent | Dia Imaging Analysis, Ltd. |
| K201411 | Visage Breast Density | Jan 29, 2021 | Substantially Equivalent | Visage Imaging GmbH |
| K201195 | syngo.via MI Workflows, syngo MBF | Nov 18, 2020 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K202013 | WRDensity by Whiterabbit.ai | Oct 30, 2020 | Substantially Equivalent | Whiterabbit.Ai, Inc. |
| K202546 | LVivo Seamless | Sep 29, 2020 | Substantially Equivalent | Dia Imaging Analysis, Ltd. |
| K193283 | AI-Rad Companion Prostate MR | Jul 30, 2020 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K200621 | Caption Interpretation Automated Ejection Fraction Software | Jul 22, 2020 | Substantially Equivalent | Caption Health |
| K192969 | Ezra Plexo Software | Jul 10, 2020 | Substantially Equivalent | Ezra Ai, Inc. |
| K200232 | LVivo Software Application | Jun 23, 2020 | Substantially Equivalent | Dia Imaging Analysis, Ltd. |
| K200356 | MEDO ARIA | Jun 11, 2020 | Substantially Equivalent | Medo.Ai |
| K200974 | QLAB Advanced Quantification Software | Jun 03, 2020 | Substantially Equivalent | Philips Health Care |
| K192601 | uWS-MR | Jun 01, 2020 | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. |
| K192437 | Arterys MICA | Mar 25, 2020 | Substantially Equivalent | Arterys, Inc. |
| K191647 | QLAB Advanced Quantification Software | Dec 20, 2019 | Substantially Equivalent | Philips Health Care |
| K191171 | EchoGo Core | Nov 13, 2019 | Substantially Equivalent | Ultromics, Ltd. |
FEI Numbers
This FDA classification entry is associated with 217 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 217 registration numbers. Click on an entry to view related FDA registrations.