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ECHOSCAN

NIDEK CO.,LTD. · Model US-500 · UDI-DI 04987669100455

ITX IYO Prescription

510(k) clearances

4,015

Adverse events (23 deaths)

147

Recalls

396

Facilities

Description

The NIDEK US-500 Echoscan is an ultrasonic device to measure the axial length and corneal thickness and provide the information to be used for diagnosis. Axial length is one of the parameters used to determine the refractive power of an IOL prior to cataract surgery. By inputting the measured axial length with other parameters, the refractive power of an IOL can be calculated. Corneal thickness is a necessary parameter when considering the clinical influence of surgery, drugs and contact lenses upon endothelium tissue. Pachymetry is now commonly performed prior to and after corneal refractive surgery using devices such as the excimer laser. The US-500 is comprised of a touch screen, main body with a built-in printer, Pachymetry probe, and foot switch.

Recalls

Date	Firm	Reason
2025-11-17	Sheathing Technologies Inc	Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.