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Radiology FDA 510(k) clearances, last 90 days

US companies with an FDA 510(k) clearance in Radiology from Aug 2, 2026 to Oct 30, 2026. FDA data through October 30, 2026.

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Last 90 days

47 clearances in the last 90 days. The same 90 days a year earlier: 33.

For contract manufacturers and test labs

Radiology accounts for 47 US 510(k) clearances in the last 90 days. The product code with the most clearances in this window is QIH (Automated Radiological Image Processing Software). Contract manufacturers and test labs that work on Radiology devices can read the company, the device and the date below, then open the FDA record. Contacts for these companies come with a free month.

Top product codes

Product codeDevice typeClearances
QIHAutomated Radiological Image Processing Software11
LLZSystem, Image Processing, Radiological6
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic5
IYEAccelerator, Linear, Medical3
LNHSystem, Nuclear Magnetic Resonance Imaging3
47 clearances, Aug 2, 2026 to Oct 30, 2026.
Decision dateCompanyDeviceFDA record
Oct 30, 2026Dentsply Sirona, Inc.DS Core DetectK261072
Oct 29, 2026Canon Medical Informatics, Inc.Vitrea Advanced Visualization, Version 7.16K263648
Oct 28, 2026Evident Vascular, Inc.Evident Vascular™ Guidance SystemK261648
Oct 26, 2026Mim Software, Inc.MIM – KineticIDK261763
Oct 20, 2026Rivanna Medical, Inc.Accuro XVK262093
Oct 19, 2026Linatech, LLCVenusCTK260510
Oct 9, 2026Ischemaview, Inc.Rapid ICH (v4.0)K262301
Oct 7, 2026Deep Reasoning Ai, Inc.NeuroDRK262134
Oct 7, 2026Vista AI, Inc.Vista AI ScanK260092
Oct 5, 2026Inkspace Imaging, Inc.InkSpace Imaging Small Body Array (SBA12PH15x)K262813
Oct 2, 2026GE Medical Systems Ultrasound and Primary care Diagnostics, LLCVoluson Expert 18; Voluson Expert 20; Voluson Expert 22K261933
Oct 2, 2026GE Medical Systems Ultrasound & Primary Care Diagnostics, LLCLung GuidanceK261042
Sep 25, 2026Philips Ultrasound, LLCEPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemK262548
Sep 25, 2026Siemens Medical Solutions USA, Inc.syngo.CT Brain QuantificationK260055
Sep 24, 2026CIVCO Medical Instruments Co., Inc.Align Cover and Pad Guidance ToolK260114
Sep 23, 2026ProNova SolutionsVIRTUE QAK260597
Sep 22, 2026Samsung HME America, Inc., dba NeuroLogica Corp.BodyTom 64 (NL4100); OmniTom Elite (NL5000)K261125
Sep 21, 2026Ischemaview, Inc.Rapid Platform (R6.7)K261368
Sep 18, 2026Elucid Bioimaging, Inc.Elucid PlaqueIQK261855
Sep 16, 2026Stabilix, LLCAerFrame™ Alignment Laser Box (LBV2)K261865
Sep 16, 2026GE Medical Systems Ultrasound and Primary Care DiagnosticsEchoPAC Software Only / EchoPAC Plug-in (v211)K261623
Sep 16, 2026A2z Radiology Ai, Inc.a2z-Abdo-TriageK260906
Sep 11, 2026Boston Scientific CorporationSpaceOAR Flex™ SystemK262151
Sep 11, 2026Microstructure Imaging, Inc.MICSI-PETK261305
Sep 11, 2026Curvebeam AI / Curvebeam, LLCBoneVueK254072
  • Oct 30, 2026
    Dentsply Sirona, Inc.

    DS Core Detect

    K261072
  • Oct 29, 2026
    Canon Medical Informatics, Inc.

    Vitrea Advanced Visualization, Version 7.16

    K263648
  • Oct 28, 2026
    Evident Vascular, Inc.

    Evident Vascular™ Guidance System

    K261648
  • Oct 26, 2026
    Mim Software, Inc.

    MIM – KineticID

    K261763
  • Oct 20, 2026
    Rivanna Medical, Inc.

    Accuro XV

    K262093
  • Oct 19, 2026
    Linatech, LLC

    VenusCT

    K260510
  • Oct 9, 2026
    Ischemaview, Inc.

    Rapid ICH (v4.0)

    K262301
  • Oct 7, 2026
    Deep Reasoning Ai, Inc.

    NeuroDR

    K262134
  • Oct 7, 2026
    Vista AI, Inc.

    Vista AI Scan

    K260092
  • Oct 5, 2026
    Inkspace Imaging, Inc.

    InkSpace Imaging Small Body Array (SBA12PH15x)

    K262813
  • Oct 2, 2026
    GE Medical Systems Ultrasound and Primary care Diagnostics, LLC

    Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

    K261933
  • Oct 2, 2026
    GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

    Lung Guidance

    K261042
  • Sep 25, 2026
    Philips Ultrasound, LLC

    EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

    K262548
  • Sep 25, 2026
    Siemens Medical Solutions USA, Inc.

    syngo.CT Brain Quantification

    K260055
  • Sep 24, 2026
    CIVCO Medical Instruments Co., Inc.

    Align Cover and Pad Guidance Tool

    K260114
  • Sep 23, 2026
    ProNova Solutions

    VIRTUE QA

    K260597
  • Sep 22, 2026
    Samsung HME America, Inc., dba NeuroLogica Corp.

    BodyTom 64 (NL4100); OmniTom Elite (NL5000)

    K261125
  • Sep 21, 2026
    Ischemaview, Inc.

    Rapid Platform (R6.7)

    K261368
  • Sep 18, 2026
    Elucid Bioimaging, Inc.

    Elucid PlaqueIQ

    K261855
  • Sep 16, 2026
    Stabilix, LLC

    AerFrame™ Alignment Laser Box (LBV2)

    K261865
  • Sep 16, 2026
    GE Medical Systems Ultrasound and Primary Care Diagnostics

    EchoPAC Software Only / EchoPAC Plug-in (v211)

    K261623
  • Sep 16, 2026
    A2z Radiology Ai, Inc.

    a2z-Abdo-Triage

    K260906
  • Sep 11, 2026
    Boston Scientific Corporation

    SpaceOAR Flex™ System

    K262151
  • Sep 11, 2026
    Microstructure Imaging, Inc.

    MICSI-PET

    K261305
  • Sep 11, 2026
    Curvebeam AI / Curvebeam, LLC

    BoneVue

    K254072

Source: FDA public records. The K number is in Whimbrel's corpus, and the company, device, state, product code and review panel are the openFDA 510(k) fields for that K number. FDA data through October 30, 2026. Each K number links to the FDA record. openFDA data are not validated by the FDA for medical decisions. Check the FDA record before you rely on a row. openFDA 510(k) API. FDA 510(k) database.

FAQ

Is a 510(k) an FDA approval?
No. The FDA clears a device through a 510(k) when it finds the device substantially equivalent to one already sold in the US.
Where do these rows come from?
From openFDA's 510(k) records, for K numbers Whimbrel already holds. Each K number links to the FDA 510(k) database.
Why do some review panels have no page?
A review panel page is published when the last 90 days have 10 or more US clearances in that panel.

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