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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- HKXTonometer, Ac-Powered2Product Code
- HKYTonometer, Manual2Product Code
- HKZSterilizer, Tonometer1Product Code
- HLACalibrator, Tonometer2Product Code
- HLCInstrument, Measuring, Stereopsis1Product Code
- HLERuler, Nearpoint (Punctometer)1Product Code
- HLFDevice, Measuring, Lens Radius, Ophthalmic1Product Code
- HLGPupillometer, Ac-Powered1Product Code
- HLHPupillometer, Manual1Product Code
- HLIOphthalmoscope, Ac-Powered2Product Code
- HKMRetinoscope, Battery-Powered1Product Code
- HKNRefractor, Manual, Non-Powered, Including Phoropter1Product Code
- HKORefractometer, Ophthalmic1Product Code
- HKQPrism, Rotary, Ophthalmic1Product Code
- HKRLens, Maddox1Product Code
- HKSPrism, Gonioscopic1Product Code
- HKTPrism, Fresnel, Ophthalmic1Product Code
- HKWPrism, Bar, Ophthalmic1Product Code
- KYHEndoscope, Ophthalmic2Product Code
- MPAEndoilluminator2Product Code
- NKZEndoilluminator, Reprocessed2Product Code
- HITTester, Color Vision1Product Code
- HIWAnomaloscope1Product Code
- HIXMaxwell Spot, Ac-Powered1Product Code
- HIYBrush, Haidinger, (Including Macular Integrity)1Product Code
- HJAPhotokeratoscope1Product Code
- HJBInstrument, Measuring, Corneal Radius1Product Code
- HJCEsthesiometer, Ocular1Product Code
- HJDIlluminator, Color Vision Plate1Product Code
- HJILens, Fundus, Hruby, Diagnostic1Product Code
- HJJLens, Fresnel, Flexible, Diagnostic1Product Code
- HJKLens, Contact, Polymethylmethacrylate, Diagnostic2Product Code
- HJLLens, Condensing, Diagnostic1Product Code
- HJMTransilluminator, Ac-Powered2Product Code
- HJNTransilluminator, Battery-Powered1Product Code
- HJOBiomicroscope, Slit-Lamp, Ac-Powered2Product Code
- HJQStereoscope, Ac-Powered1Product Code
- HJRStereoscope, Battery-Powered1Product Code
- HJSTest, Spectacle Dissociation, Ac-Powered (Lancaster)1Product Code
- HJTHaploscope1Product Code
- HJWAdaptometer (Biophotometer)1Product Code
- HKDTape, Nystagmus1Product Code
- HKFMirror, Headband, Ophthalmic1Product Code
- HKGFornixscope1Product Code
- HKICamera, Ophthalmic, Ac-Powered2Product Code
- HKLRetinoscope, Ac-Powered2Product Code
- HLJOphthalmoscope, Battery-Powered2Product Code
- HLKScreen, Tangent, Target, Battery-Powered1Product Code
- HLLMonitor, Eye Movement2Product Code
- HLMInstrument, Measuring, Lens, Ac-Powered1Product Code
- HLNGauge, Lens, Ophthalmic1Product Code
- HLOTest, Spectacle Dissociation, Battery-Powered (Lancaster)1Product Code
- HLPTarget, Fusion And Stereoscopic1Product Code
- HLQKeratoscope, Ac-Powered1Product Code
- HLRKeratoscope, Battery-Powered1Product Code
- HLSExophthalmometer1Product Code
- HLTPreamplifier, Ac-Powered, Ophthalmic2Product Code
- HLWPreamplifier, Battery-Powered, Ophthalmic2Product Code
- HLXPhotostimulator, Ac-Powered2Product Code
- HLZElectrode, Corneal2Product Code
- HMCMonitor, Eye Movement, Diagnostic2Product Code
- HMDChair, Ophthalmic, Manual1Product Code
- HMEChair, Ophthalmic, Ac-Powered1Product Code
- HMFStand, Instrument, Ac-Powered, Ophthalmic1Product Code
- HMGStand, Instrument, Ophthalmic, Non-Powered1Product Code
- HMHRack, Skiascopic1Product Code
- HMJScreen, Tangent, Projection, Battery-Powered1Product Code
- HMKEuthyscope, Ac-Powered2Product Code
- HMLEuthyscope, Battery-Powered1Product Code
- HMMDistometer1Product Code
- HOJScreen, Tangent, Target1Product Code
- HOKScreen, Tangent, Projection, Ac-Powered1Product Code
- HOLScreen, Tangent, Felt (Campimeter)1Product Code
- HOMScreen, Tangent, Ac-Powered (Campimeter)1Product Code
- HONPerimeter, Manual1Product Code
- HOOPerimeter, Ac-Powered1Product Code
- HOPCampimeter, Stereo, Battery-Powered1Product Code
- HOQGrid, Amsler1Product Code
- HORSimulatan (Including Crossed Cylinder)1Product Code
- HOSProjector, Ophthalmic1Product Code
- HOWDrum, Opticokinetic1Product Code
- HOXChart, Visual Acuity1Product Code
- HPAFrame, Trial, Ophthalmic1Product Code
- HPBClip, Lens, Trial, Ophthalmic1Product Code
- HPCSet, Lens, Trial, Ophthalmic1Product Code
- HPDLens, Bagolini1Product Code
- HPJInstrument, Visual Field, Laser2Product Code
- HPKTonograph2Product Code
- HPLDevice, Fixation, Ac-Powered, Ophthalmic1Product Code
- HPTPerimeter, Automatic, Ac-Powered1Product Code
- HPWProbe And Counter, Isotope, For Phosphorus 322Product Code
- HRECabinet, Instrument, Ac-Powered, Ophthalmic1Product Code
- HRIPupillograph1Product Code
- KYDStrip, Schirmer1Product Code
- MMFPhotorefractor2Product Code
- MMQTopographer, Corneal, Ac-Powered1Product Code
- MSGOphthalmoscopes, Replacement Batteries, Hand-Held2Product Code
- MXKDevice, Analysis, Anterior Segment2Product Code
- MYCOphthalmoscope, Laser, Scanning2Product Code
- NCFAberrometer, Ophthalmic1Product Code
- NFDSelector, Color, Spectacle, Lens, Tint1Product Code
- NJGFlasher, Afterimage, Ophthalmic2Product Code
- NJJTonometer, Analyzer, Ocular Blood Flow2Product Code
- NOGTopographer, Corneal, Battery Powered1Product Code
- NOHPhotokeratoscope, Battery Powered1Product Code
- NOIStand, Instrument, Ophthalmic, Battery Powered1Product Code
- NQEMicroscope, Specular2Product Code
- NXRFixation, Vision Training, Binocular1Product Code
- NYKOphthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)2Product Code
- OBOTomography, Optical Coherence2Product Code
- OUMAdaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation1Product Code
- PIBDiabetic Retinopathy Detection Device2Product Code
- PJZCamera, Ophthalmic, General-Use2Product Code
- PLZOcular Pattern Recorder2Product Code
- PMWStrabismus Detection Device2Product Code
- PUEBiomicroscope, Slit-Lamp, Ac-Powered, Exempt2Product Code
- QERCamera, Ophthalmic, Slit-Scanning2Product Code
- NFFDevice, Storage, Images, Ophthalmic1Product Code
- NFGDevice, Communications, Images, Ophthalmic1Product Code
- NFHDigitizer, Images, Ophthalmic2Product Code
- NFIDevice, Hardcopy, Images, Ophthalmic2Product Code
- NFJSystem, Image Management, Ophthalmic2Product Code
- K234076iCare ALTIUS CW2Cleared 510(K)
- K232828IMAGEnet6 Ophthalmic Data System2Cleared 510(K)
- K232944CALLISTO eye2Cleared 510(K)
- K232555Harmony2Cleared 510(K)
- K231676CALLISTO eye2Cleared 510(K)
- K232088Altris IMS2Cleared 510(K)
- K220929Excelsior2Cleared 510(K)
- K213527FORUM2Cleared 510(K)
- K211715RetinAI Discovery2Cleared 510(K)
- K210396Harmony Referral System2Cleared 510(K)
- K203244CellChek 20 rc2Cleared 510(K)
- K200422Image Quality Analyzer (IQA)2Cleared 510(K)
- K201273ImageSPECTRUM2Cleared 510(K)
- K200954Glaucoma Module2Cleared 510(K)
- K200385CONTINUUM PACS2Cleared 510(K)
- K200275OVision Imaging System2Cleared 510(K)
- K191615Huvitz Imaging System2Cleared 510(K)
- K190056KOWA VK-2s2Cleared 510(K)
- K181501Afina2Cleared 510(K)
- K182318Retina Workplace2Cleared 510(K)
- K182376Harmony2Cleared 510(K)
- K181345Image Filing Software NAVIS-EX2Cleared 510(K)
- K181016Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System2Cleared 510(K)
- K180858CALLISTO eye2Cleared 510(K)
- K173689Ophthalmic Software Platform RX2Cleared 510(K)
- K171370IMAGEnet 6 Ophthalmic Data System2Cleared 510(K)
- K170638Retina Workplace2Cleared 510(K)
- K171098AXIS Image Management System2Cleared 510(K)
- K161829Huvitz Imaging System2Cleared 510(K)
- K162039OptosAdvance 4.0 Software2Cleared 510(K)
- K151952Synergy ODM2Cleared 510(K)
- K150467Retina Workplace2Cleared 510(K)
- K141922IRIS INTELLIGENT RETINAL IMAGING SYSTEM2Cleared 510(K)
- K141297FORUM GLAUCOMA WORKPLACE2Cleared 510(K)
- K142423EyeSuite Imaging2Cleared 510(K)
- K132438IMAGENET 5 PC SOFTWARE SYSTEM2Cleared 510(K)
- K132667SYNERGY ODM2Cleared 510(K)
- K130648FORUM GLAUCOMA WORKPLACE2Cleared 510(K)
- K130453EXCELSIOR2Cleared 510(K)
- K123464CALLISTO EYE2Cleared 510(K)
- K122938FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH2Cleared 510(K)
- K113696OPTOS ADVANCE2Cleared 510(K)
- K110869CARA2Cleared 510(K)
- K110006OIS SYMPHONY IMAGE MANAGMENT SYSTEM2Cleared 510(K)
- K093313SYNERGY2Cleared 510(K)
- K090266MATCHEDFLICKER2Cleared 510(K)
- K090439FORUM2Cleared 510(K)
- K081797IMAGE STORAGE SYSTEM, MODEL KSS-4002Cleared 510(K)
- K082364IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR2Cleared 510(K)
- K071299IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP2Cleared 510(K)
- K013694NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)2Cleared 510(K)
- QTODigital Visual Acuity Test1Product Code
- QTWDigital Amsler Grid1Product Code
- QZPCamera, Ophthalmic, Non-Prescription2Product Code
- SBIManual Refractor, 3d Display1Product Code
- SBNDigital Therapy Device For Convergence Insufficiency1Product Code
- SCWDigital Prismatic Correction1Product Code
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Afina
- Page Type
- Cleared 510(K)
- 510(k) Number
- K181501
- 510(k) Type
- Traditional
- Applicant
- NeuroVision Imaging, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/2/2018
- Days to Decision
- 148 days
- Submission Type
- Summary