Company name

Crystalvue Medical corporation

Product name

Crystalvue NFC-700™ (Non-Mydriatic Auto Fundus Camera / Automated FundusVue)

Certification

1.93/42/EEC/M5 Medical Device Directive (CE1639)
2.FDA 510K
3.TFDA approved Medical Device (MOHW-MD-No.005113)
4.Electromagnetic Compatibility (EMC): EN 60601-1-2 (The NFC-700 has been tested to comply with the emission and immunity requirements of EN60601-1-2. The NFC-700 is intended for use in an electromagnetic environment where radiated RF disturbances are not beyond the standard defined in EN60601-1-2.)
5.Certification: Under IEC 60601-1

Awards

1.2019 Taipei Biotech Awards > Go-Globe Awards (Special Mention Award)
2.Taiwan Excellence 2020

Product summary

NFC-700 with the fully automatic 3D tracking and image capturing is the most essential diagnosis instrument for ophthalmologists to inspect and record the patients’ retina. With non-mydriatic nature, the patients' uncomfortableness can be minimized during diagnosis process. The touch screen makes it easy to control all of the operating procedures.

NFC-700 provides non-mydriatic color retina and external images of the eye as an aid to clinicians in the evaluation and diagnosis of eye disease. NFC-700, which uses NIR LED as illumination when aligning to the retina of a patient’s eyes, only provides images and does not provide any diagnostic or pathological analysis or conclusions in any way. Furthermore, NFC-700 is not intended to be used as the sole diagnostic aid in disease identification, classification or management.

Others

The NFC-700™, as an excellent retinal imaging system, is perfectly corresponding to the purpose of the Vietnam Health Programme, in the aspect of chronic disease surveillance. Taking retinal inspection regularly is helpful for finding & controlling retinal diseases (especially diabetic retinopathy/ age-related macular degeneration (AMD)/ glaucoma/ etc.), by which caused the risk on blindness can be reduced.