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FDA 510(k)

RETCAM 3 OPHTHALMIC IMAGING SYSTEM

K-Number: K081858 · 2008-11-05

ApplicantClarity Medical Systems
Decision Date2008-11-05
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RETCAM 3 OPHTHALMIC IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Clarity Medical Systems. It received FDA 510(k) clearance on 2008-11-05 under 510(k) number K081858. 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 RETCAM 3 OPHTHALMIC IMAGING SYSTEM?

RETCAM 3 OPHTHALMIC IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2008-11-05. The listed applicant is Clarity Medical Systems. The 510(k) number is K081858.

When did RETCAM 3 OPHTHALMIC IMAGING SYSTEM receive FDA 510(k) clearance?

RETCAM 3 OPHTHALMIC IMAGING SYSTEM received FDA 510(k) clearance on 2008-11-05, under 510(k) number K081858.

Who is the listed applicant for RETCAM 3 OPHTHALMIC IMAGING SYSTEM?

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

What is the FDA product code for RETCAM 3 OPHTHALMIC IMAGING SYSTEM?

The FDA product code for RETCAM 3 OPHTHALMIC 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 Clarity Medical 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.

K102859RETCAM 3 OPTHALMIC IMAGING SYSTEMK090326RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMSK083771RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP

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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