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FDA 510(k)

DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM

K-Number: K913929 · 1991-11-27

ApplicantOphthalmic Imaging Systems
Decision Date1991-11-27
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM 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 1991-11-27 under 510(k) number K913929. 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 DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM?

DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1991-11-27. The listed applicant is Ophthalmic Imaging Systems. The 510(k) number is K913929.

When did DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM receive FDA 510(k) clearance?

DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM received FDA 510(k) clearance on 1991-11-27, under 510(k) number K913929.

Who is the listed applicant for DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM?

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 DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM?

The FDA product code for DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM is HKI.

Related Clinical Trials

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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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 EYESCANK982689WINSTATION RETINAL IMAGERK913118GLAUCOMA-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.

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, Inc.

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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