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FDA 510(k)

IRI INTEGRATED RETINAL IMAGER

K-Number: K062295 · 2006-10-20

ApplicantMedivision Medical Imaging, Ltd.
Decision Date2006-10-20
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IRI INTEGRATED RETINAL IMAGER is the device name listed in this FDA 510(k) record. The listed applicant is Medivision Medical Imaging, Ltd.. It received FDA 510(k) clearance on 2006-10-20 under 510(k) number K062295. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRI INTEGRATED RETINAL IMAGER?

IRI INTEGRATED RETINAL IMAGER is a medical device that received FDA 510(k) clearance on 2006-10-20. The listed applicant is Medivision Medical Imaging, Ltd.. The 510(k) number is K062295.

When did IRI INTEGRATED RETINAL IMAGER receive FDA 510(k) clearance?

IRI INTEGRATED RETINAL IMAGER received FDA 510(k) clearance on 2006-10-20, under 510(k) number K062295.

Who is the listed applicant for IRI INTEGRATED RETINAL IMAGER?

The FDA 510(k) record lists Medivision Medical Imaging, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRI INTEGRATED RETINAL IMAGER?

The FDA product code for IRI INTEGRATED RETINAL IMAGER is HKI.

Related Clinical Trials

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Other records listing Medivision Medical Imaging, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K953974CAMVISION 1000K953972ANGIOVISION VIEWING STATIONK953973ANGIOVISION 1000

Related Devices (Code: HKI)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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