BEUDAMED
    Product Code: OBO FDA class 2 21 CFR 886.1570

    Tomography, Optical Coherence

    Ophthalmic

    The Optical Coherence Tomography (OCT) system (product code OBO) is an ophthalmic diagnostic device used for viewing, imaging, measurement, and analysis of ocular structures, aiding in the detection and management of various ocular diseases such as glaucoma, macular degeneration, and diabetic retinopathy. OCT uses light-based interferometry to generate high-resolution cross-sectional images of retinal layers and other ocular tissues. This device is FDA Class 2 under regulation 886.1570 in the Ophthalmic specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    66
    FEI Numbers
    29
    Registration Numbers
    30
    Unique Applicants
    19
    Years Active
    20

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    Basic Information

    Product Code
    OBO
    Device Class
    FDA class 2
    Regulation Number
    886.1570
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    1

    Device Characteristics

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

    Definition

    Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 66 510(k) clearances via K numbers.

    K Number Device Name
    K253837 SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module
    K252633 UNITY DX (UDX)
    K250553 Tomey Cornea/Anterior Segment OCT (CASIA2)
    K250868 SPECTRALIS HRA+OCT and variants
    K240924 Anterion
    K241163 SPECTRALIS with Flex Module
    K241081 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System
    K240221 SPECTRALIS HRA+OCT and variants
    K233933 CIRRUS™ HD-OCT Model 6000
    K233602 P200TE (A10700)
    K233561 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))
    K233421 RESCAN 700
    K231222 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
    K223557 SPECTRALIS HRA+OCT and variants
    K230897 Anterion
    K221601 MS-39
    K231673 P200TE (A10700)
    K222200 CIRRUS HD-OCT
    K221320 Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX
    K222166 SOLIX
    K213265 Tomey Cornea/Anterior Segment OCT CASIA2
    K211817 Anterion
    K201252 Spectralis HRA+OCT and variants
    K200516 OCT-Camera ID 21101A3
    K192391 Spectralis HRA+OCT and Variants
    K190732 P200TxE
    K182942 Canon OCT-A1
    K181534 CIRRUS HD-OCT
    K180229 RESCAN 700, CALLISTO eye
    K182569 Spectralis HRA+OCT and variants with High Magnification Module
    K181594 Spectralis HRA+OCT and variants with OCT Angiography Module
    K173648 Spectralis HRA + OCT and variants
    K180660 Avanti
    K173707 P200TE
    K173119 DRI OCT Triton
    K172649 Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor
    K163195 PRIMUS
    K163475 iVue
    K170164 3D OCT-1 Maestro
    K162783 EnFocus 2300, EnFocus 4400
    K161194 PLEX Elite 9000 SS-OCT
    K161509 3D OCT-1 Maestro
    K152205 Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor
    K150977 CIRRUS HD-OCT
    K141844 RESCAN 700, CALLISTO EYE
    K133217 CIRRUS PHOTO
    K132323 RS-3000 ADVANCE
    K121622 NIDEK RS-3000
    K121043 OPTOS OCT/SLO MICROPERIMETER
    K121993 SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT
    K112184 CIRRUS PHOTO
    K111157 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES
    K113129 SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)
    K111505 RTVUE CAM WITH CORNEAL POWER UPGRADE
    K101223 SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA
    K091404 IVUE, MODEL 100
    K092470 OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000
    K083291 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000
    K083316 3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM
    K072971 TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS
    K080460 SPECTRAL OCT/SLO
    K071839 SOCT COPERNICUS, MODEL 15205
    K071250 CA, MODEL: CAM
    K063388 TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM
    K063191 HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT
    K062552 RTVUE

    FEI Numbers

    This FDA classification entry is associated with 29 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 30 registration numbers. Click on an entry to view related FDA registrations.