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SONOMED INC

VUPAD · Ophthalmic

510(k): 1 Recall: 0 UDI: 12 MAUDE: 0 Class.: 66

510(k) Clearances (1)

VUPAD

2014-04-01

Substantially Equivalent

UDI Registrations (12)

VuPad Ophthalmic Ultrasound System

The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes capabilities for A-Scan, B-Scan, and UBM (high frequency B-scan). The device is used by coupling the probe/transducer to the eye either by direct contact or immersion methods. The VuPad B-Scan mode produces a live, two-dimensional image t…

VuPad Ophthalmic Ultrasound System

The VuPad BP Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications by imaging the internal structures of the eye.The VuPad BP is a multi-purpose, computer-based,ultrasonic diagnostic system that produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior …

VuPad Ophthalmic Ultrasound System

The VuPad AP Ophthalmic Ultrasound System is a portable, ultrasound biometric ruler that is a non-invasive, active device intended for imaging ocular features for diagnostic purposes and measuring central corneal thickness. The A-Scan system allows for measuring the axial length (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implant…

VuPad Ophthalmic Ultrasound System

The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes capabilities for B-Scan and UBM (high frequency B-scan). The device is used by coupling the probe/transducer to the eye either by direct contact or immersion methods. The VuPad B-Scan mode produces a live, two-dimensional image to facilit…

VuPad Ophthalmic Ultrasound System

The VuPad A Ophthalmic Ultrasound System is a portable, ultrasound biometric ruler that is a non-invasive, active device intended for imaging ocular features for diagnostic purposes. The A-Scan system allows for measuring the axial length (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implanted lens. The VuPad A-Scan is used by coup…

VuPad Ophthalmic Ultrasound System

The VuPad A/B/P Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes A-Scan, B-Scan and pachymeter capabilities. The device is used by coupling the probe/transducer to the eye either by direct contact or immersion methods. The VuPad B-Scan mode produces a live, two-dimensional image to facilitate the…

VuPad Ophthalmic Ultrasound System

The VuPad B-Scan Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications by imaging the internal structures of the eye.The VuPad B-Scan is a multi-purpose, computer-based,ultrasonic diagnostic system that produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the po…

VuPad Ophthalmic Ultrasound System

The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic, ultrasound biomicroscopy device intended for use in ophthalmic applications.The ultrasound probe with the system is a water path probe with 35 MHz transducer providing high resolution images. The VuPad B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologie…

VuPad Ophthalmic Ultrasound System

The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes capabilities for A-Scan, B-Scan, UBM (high frequency B-scan),a nd pachymetry. The device is used by coupling the probe/transducer to the eye either by direct contact or immersion methods. The VuPad B-Scan mode produces a live, two-dimensi…

VuPad Ophthalmic Ultrasound System

The VuPad A/B-Scan Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes both A-Scan and B-Scan capabilities. The device is used by coupling the probe/transducer to the eye either by direct contact or immersion methods. The VuPad B-Scan mode produces a live, two-dimensional image to facilitate the ide…

VuPad Ophthalmic Ultrasound System

The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes capabilities for B-Scan, UBM (high frequency B-scan), and pachymetry. The device is used by coupling the probe/transducer to the eye either by direct contact or immersion methods. The VuPad B-Scan mode produces a live, two-dimensional ima…

FDA Classification (66)

Clip, Iris Retractor

Ophthalmic

Dilator, Expansive Iris (Accessory)

Ophthalmic

Implant, Eye Valve

Ophthalmic

Hydrophilic Re-Coating Solution

Ophthalmic

Fixation, Vision Training, Binocular

Ophthalmic

Collagen Corneal Shield

Ophthalmic

Pupillometer, Manual

Ophthalmic

Aid, Vision, Electronic, Ac-Powered

Ophthalmic

Photostimulator, Ac-Powered

Ophthalmic

Tubing, Replacement, Phacofragmentation Unit

Ophthalmic

Device, Fixation, Ac-Powered, Ophthalmic

Ophthalmic

Corneal Inlay Inserter Handle

Ophthalmic

Vitrectomy, Instrument Cutter

Ophthalmic

Sterilizer, Tonometer

Ophthalmic

Camera, Ophthalmic, General-Use

Ophthalmic

Euthyscope, Ac-Powered

Ophthalmic

Projector, Ophthalmic

Ophthalmic

Instrument, Measuring, Stereopsis

Ophthalmic

Lens, Intraocular, Toric Optics

Ophthalmic

Drum, Opticokinetic

Ophthalmic

Expander, Tissue, Orbital

Ophthalmic

Ruler, Nearpoint (Punctometer)

Ophthalmic

Lens, Fundus, Hruby, Diagnostic

Ophthalmic

Lens, Contact, For Color Vision Deficiency

Ophthalmic

Retractor, Ophthalmic

Ophthalmic

Sunglasses (Non-Prescription Including Photosensitive)

Ophthalmic

Intraocular Lens

Ophthalmic

Applicator, Negative Pressure, External, Ocular

Ophthalmic

Tester, Color Vision

Ophthalmic

Keratome, Water Jet

Ophthalmic

Clip, Lens, Trial, Ophthalmic

Ophthalmic

Maxwell Spot, Ac-Powered

Ophthalmic

Cannula, Ophthalmic

Ophthalmic

Unit, Cryophthalmic

Ophthalmic

Topographer, Corneal, Ac-Powered

Ophthalmic

Stand, Instrument, Ophthalmic, Battery Powered

Ophthalmic

Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered

Ophthalmic

Esthesiometer, Ocular

Ophthalmic

Burr, Corneal, Manual

Ophthalmic

Ocular Peg, Exempt

Ophthalmic

Lenses, Soft Contact, Daily Wear

Ophthalmic

System, Monitoring, For Progress Of Labor

Ophthalmic

Intranasal Electrostimulation Device

Ophthalmic

Lens, Contact (Other Material) - Daily

Ophthalmic

Retinoscope, Ac-Powered

Ophthalmic

Ophthalmoscope, Battery-Powered

Ophthalmic

Engine, Trephine, Accessories, Ac-Powered

Ophthalmic

Keratome, Ac-Powered

Ophthalmic

Aid, Vision, Optical, Battery-Powered

Ophthalmic

Photokeratoscope, Battery Powered

Ophthalmic

Eyelid Thermal Pulsation System

Ophthalmic

Screen, Tangent, Target, Battery-Powered

Ophthalmic

Marker, Ocular

Ophthalmic

Ophthalmoscopes, Replacement Batteries, Hand-Held

Ophthalmic

Light, Headband, Surgical

Ophthalmic

Prism, Fresnel, Ophthalmic

Ophthalmic

Device, Measuring, Lens Radius, Ophthalmic

Ophthalmic

Keratoprosthesis, Permanent Implant

Ophthalmic

Preamplifier, Ac-Powered, Ophthalmic

Ophthalmic

System, In-Office Tinting, Contact Lenses

Ophthalmic

Test, Spectacle Dissociation, Ac-Powered (Lancaster)

Ophthalmic

Sponge, Ophthalmic

Ophthalmic

Forceps, Ophthalmic

Ophthalmic

Weights, Eyelid, External

Ophthalmic

Table, Instrument, Powered, Ophthalmic

Ophthalmic

Engine, Trephine, Accessories, Battery-Powered

Ophthalmic