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FDA 510(k)

DIGITAL EYE-FUNDUS CAMERA

K-Number: K120982 · 2012-09-28

ApplicantMedimaging Integrated Solutions, Inc. (Miis)
Decision Date2012-09-28
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DIGITAL EYE-FUNDUS CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Medimaging Integrated Solutions, Inc. (Miis). It received FDA 510(k) clearance on 2012-09-28 under 510(k) number K120982. 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 DIGITAL EYE-FUNDUS CAMERA?

DIGITAL EYE-FUNDUS CAMERA is a medical device that received FDA 510(k) clearance on 2012-09-28. The listed applicant is Medimaging Integrated Solutions, Inc. (Miis). The 510(k) number is K120982.

When did DIGITAL EYE-FUNDUS CAMERA receive FDA 510(k) clearance?

DIGITAL EYE-FUNDUS CAMERA received FDA 510(k) clearance on 2012-09-28, under 510(k) number K120982.

Who is the listed applicant for DIGITAL EYE-FUNDUS CAMERA?

The FDA 510(k) record lists Medimaging Integrated Solutions, Inc. (Miis) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGITAL EYE-FUNDUS CAMERA?

The FDA product code for DIGITAL EYE-FUNDUS CAMERA is HKI.

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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.

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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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