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FDA 510(k)

RETCAM 3 OPTHALMIC IMAGING SYSTEM

K-Number: K102859 · 2011-04-20

ApplicantClarity Medical Systems
Decision Date2011-04-20
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RETCAM 3 OPTHALMIC 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 2011-04-20 under 510(k) number K102859. 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 OPTHALMIC IMAGING SYSTEM?

RETCAM 3 OPTHALMIC IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-04-20. The listed applicant is Clarity Medical Systems. The 510(k) number is K102859.

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

RETCAM 3 OPTHALMIC IMAGING SYSTEM received FDA 510(k) clearance on 2011-04-20, under 510(k) number K102859.

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

The FDA product code for RETCAM 3 OPTHALMIC 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.

K090326RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMSK083771RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCPK081858RETCAM 3 OPHTHALMIC IMAGING SYSTEM

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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