BEUDAMED
    Product Code: NQQ FDA class 2 21 CFR 892.1560

    System, Imaging, Optical Coherence Tomography (Oct)

    Radiology

    The optical coherence tomography (OCT) imaging system is a radiology device that uses back-reflected light to create high-resolution two-dimensional cross-sectional images of biological tissues, analogous to ultrasound but using light rather than sound waves, with applications in ophthalmic imaging and other specialties. It is classified as FDA Class 2 under regulation 892.1560 in the Radiology specialty, requiring 510(k) clearance. Product code NQQ is eligible for third-party review and is not an implant or life-sustaining device.

    View on FDA
    510(k)s
    46
    FEI Numbers
    27
    Registration Numbers
    27
    Unique Applicants
    21
    Years Active
    22

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    Basic Information

    Product Code
    NQQ
    Device Class
    FDA class 2
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 46 510(k) clearances via K numbers.

    K Number Device Name
    K253459 OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)
    K251730 LIA Console (542-7)
    K253101 HyperVue™ Imaging System - Integrated
    K252851 deepLive (OSP12 + DMS)
    K251198 HyperVue™ Software
    K250684 OPUSWAVE Dual Sensor Imaging System
    K242924 OPXION Optical Skin Viewer (OPXSV1-01F)
    K242098 Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)
    K243016 Starlight Imaging Catheter
    K242239 HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))
    K240610 deepLive
    K232386 ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6
    K230691 HyperVue™ Imaging System
    K221257 SpectraWAVE Imaging System
    K210458 OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
    K203578 OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System
    K201552 ApolloVue S100 Image System
    K192922 Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter
    K191117 NvisionVLE Low-profile Optical Probe
    K183320 Ilumien Optis, Optis Integrated, Optis Mobile
    K190404 OTIS Optical Coherence Tomography SYstem
    K182616 NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
    K182261 NvisionVLE Imaging System, NvisionVLE Optical Probe
    K171560 OTIS Optical Coherence Tomography System
    K162466 LuminScan (TM) Imaging System
    K153283 VivoSight Dx Topical OCT System
    K160878 OPTIS Metallic Stent Optimization E.4 SW
    K160240 Perimeter Otis™ 1.0 Optical Coherence Tomography System
    K153479 NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System
    K152120 OPTIS Mobile System
    K151286 OPTIS Integrated System Mobile Workstation
    K150878 ILUMIEN OPTIS
    K150237 ILUMIEN, Drageonfly OPTIS Imaging Catheter
    K143678 NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory
    K133209 FORESEE (4C) IMAGING SYSTEM
    K132800 SKINTELL
    K120800 NVISION VLE IMAGING SYSTEM
    K123369 ILUMIEN OPTIS
    K121195 NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER
    K112770 NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER
    K111201 C7 XR IMAGING SYSTEM
    K102599 TOMOPHASE OCTIS
    K093857 C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES
    K093520 VIVOSIGHT TOPICAL OCT SYSTEM
    K042894 IMALUX NIRIS IMAGING SYSTEM
    K033783 IMALUX OCT IMAGING SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 27 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 27 registration numbers. Click on an entry to view related FDA registrations.