Anesthesiology
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- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
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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
- 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
Device, Communications, Images, Ophthalmic
- Page Type
- Product Code
- Regulation Medical Specialty
- Radiology
- Review Panel
- Ophthalmic
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 892.2020
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 892.2020 Medical image communications device
§ 892.2020 Medical image communications device.
(a) Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
[63 FR 23387, Apr. 29, 1998; 63 FR 44998, Aug. 24, 1998, as amended at 65 FR 2323, Jan. 14, 2000, 86 FR 20283, Apr. 19, 2021]