Cleared Traditional

K120982 - DIGITAL EYE-FUNDUS CAMERA

K120982 is an FDA 510(k) clearance for DIGITAL EYE-FUNDUS CAMERA, manufactured by Medimaging Integrated Solutions, Inc. (Miis). The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K120982 · Medimaging Integrated Solutions, Inc. (Miis) · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
179d
Days
Class 2
Risk

K120982 is an FDA 510(k) clearance for the DIGITAL EYE-FUNDUS CAMERA. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Medimaging Integrated Solutions, Inc. (Miis) (Hsinchu, CN). The FDA issued a Cleared decision on September 28, 2012 after a review of 179 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1120 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K120982

510(k) Number K120982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2012
Decision Date September 28, 2012
Days to Decision 179 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 110d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKI Device Classification - Class 2, Special Controls

Product Code HKI Camera, Ophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HKI Camera, Ophthalmic, Ac-powered

All 146
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K120982.
ICAM FUNDUS CAMERA
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PANOPTIC
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NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX
K113451 · Nidek Technologies Srl · May 2012
KOWA VX-20
K112330 · Kowa Co. , Ltd. · Feb 2012
NON-CONTACT TEAR FILM THERMOGRAGH
K111771 · United Integrated Services Co., Ltd. · Nov 2011
K120982 · DIGITAL EYE-FUNDUS CAMERA
Download PDF FDA Summary Medimaging Integrated…