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FDA 510(k)

RETINAL FUNCTIONAL IMAGER (RFI)

K-Number: K062416 · 2006-11-17

ApplicantOptical Imaging , Ltd.
Decision Date2006-11-17
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RETINAL FUNCTIONAL IMAGER (RFI) is the device name listed in this FDA 510(k) record. The listed applicant is Optical Imaging , Ltd.. It received FDA 510(k) clearance on 2006-11-17 under 510(k) number K062416. 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 RETINAL FUNCTIONAL IMAGER (RFI)?

RETINAL FUNCTIONAL IMAGER (RFI) is a medical device that received FDA 510(k) clearance on 2006-11-17. The listed applicant is Optical Imaging , Ltd.. The 510(k) number is K062416.

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

RETINAL FUNCTIONAL IMAGER (RFI) received FDA 510(k) clearance on 2006-11-17, under 510(k) number K062416.

Who is the listed applicant for RETINAL FUNCTIONAL IMAGER (RFI)?

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

What is the FDA product code for RETINAL FUNCTIONAL IMAGER (RFI)?

The FDA product code for RETINAL FUNCTIONAL IMAGER (RFI) 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 Optical 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.

K080180MODIFICATION TO RETINAL FUNCTION IMAGER (RFI)

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

View on FDA Database →

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

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