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FDA 510(k)

RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS

K-Number: K090326 · 2009-11-25

ApplicantClarity Medical Systems
Decision Date2009-11-25
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS 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 2009-11-25 under 510(k) number K090326. 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 RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS?

RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS is a medical device that received FDA 510(k) clearance on 2009-11-25. The listed applicant is Clarity Medical Systems. The 510(k) number is K090326.

When did RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS receive FDA 510(k) clearance?

RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS received FDA 510(k) clearance on 2009-11-25, under 510(k) number K090326.

Who is the listed applicant for RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS?

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 RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS?

The FDA product code for RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS 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 SYSTEMK083771RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCPK081858RETCAM 3 OPHTHALMIC IMAGING SYSTEM

Related Devices (Code: HKI)

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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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