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FDA 510(k)

WINSTATION RETINAL IMAGER

K-Number: K982689 · 1998-10-23

ApplicantOphthalmic Imaging Systems
Decision Date1998-10-23
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

WINSTATION RETINAL IMAGER is the device name listed in this FDA 510(k) record. The listed applicant is Ophthalmic Imaging Systems. It received FDA 510(k) clearance on 1998-10-23 under 510(k) number K982689. 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 WINSTATION RETINAL IMAGER?

WINSTATION RETINAL IMAGER is a medical device that received FDA 510(k) clearance on 1998-10-23. The listed applicant is Ophthalmic Imaging Systems. The 510(k) number is K982689.

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

WINSTATION RETINAL IMAGER received FDA 510(k) clearance on 1998-10-23, under 510(k) number K982689.

Who is the listed applicant for WINSTATION RETINAL IMAGER?

The FDA 510(k) record lists Ophthalmic Imaging Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WINSTATION RETINAL IMAGER?

The FDA product code for WINSTATION RETINAL IMAGER is HKI.

Related Clinical Trials

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Other records listing Ophthalmic Imaging Systems 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.

K110006OIS SYMPHONY IMAGE MANAGMENT SYSTEMK092374OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCANK913929DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEMK913118GLAUCOMA-SCOPE

Related Devices (Code: HKI)

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.

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Official Source

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