Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The RetCam Portable Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.
NATUS MEDICAL INC
RetCam Portable
In Commercial Distribution



  • Ophthalmic fundus camera
The RetCam Shuttle Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.
NATUS MEDICAL INC
RetCam Shuttle
In Commercial Distribution



  • Ophthalmic fundus camera
RetCam 3 Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.
NATUS MEDICAL INC
RetCam 3
In Commercial Distribution



  • Ophthalmic fundus camera
No Description
ILOODA.CO.,LTD
RetiCapture
In Commercial Distribution

  • 08800023201017 ()


  • Ophthalmic fundus camera
HFC-1 fundus camera is intended to capture digital images for the anterior and retina segment of the eye without the use of a mydriatic agent. It is intended for use as an aid to clinicians in the evaluation and diagnosis of ocular health.
Huvitz Co., Ltd.
HFC-1
In Commercial Distribution

  • 08800019600541 ()
HFC-1

  • Ophthalmic fundus camera
3D Optical Coherence Tomography OCT500 is a non-contact, high-resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing, axial cross-sectional and three dimensional imaging, and measurement of posterior ocular structures, including the retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, ganglion cell complex, macula, optic nerve head. It is also indicated for in-vivo viewing, axial cross-sectional and three dimensional imaging of anterior ocular structures, including the cornea. The instrument is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, agerelated macular degeneration, and glaucoma.
ESSILOR INTERNATIONAL
OCT2JT
In Commercial Distribution

  • 03615020000489 ()


  • Retinal optical coherence tomography system
Retina 400 is an electromedical system that allows for digitally retrieving, acquiring and processing of a retinal image, for use in ophthalmological diagnosis by medical specialists, and other uses inherent to the professional activity of other operators, optometrists and opticians, to the extent permitted by the laws and regulations for the exercise of their profession. An absolute new entry in the field for retinal imaging, the instrument allows for a direct, "live" monitoring on the computer screen, and capturing also in cases where the pupil diameter is extremely narrow. The instrument, with manual acquisition and electronically guided control, guarantees high precision and repeatability of the measurements.
ESSILOR INTERNATIONAL
RETINA 400
In Commercial Distribution

  • 03615020000267 ()


  • Ophthalmic fundus camera
No Description
ESSILOR INTERNATIONAL
ANAEYES OCT
In Commercial Distribution

  • 03615020000496 ()


  • Camera application software
Retina 800 is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent
ESSILOR INTERNATIONAL
RET1IN
In Commercial Distribution

  • 03615020000465 ()


  • Ophthalmic fundus camera
No Description
LUNEAU TECHNOLOGY OPERATIONS
Velara 200
In Commercial Distribution

  • 03664188000428 ()


  • Ophthalmic fundus camera
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