Cleared Traditional

K122572 - ICAM FUNDUS CAMERA

K122572 is an FDA 510(k) clearance for ICAM FUNDUS CAMERA, manufactured by Optovue, Inc.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K122572 · Optovue, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
141d
Days
Class 2
Risk

K122572 is an FDA 510(k) clearance for the ICAM FUNDUS CAMERA. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Optovue, Inc. (Fremont, US). The FDA issued a Cleared decision on January 11, 2013 after a review of 141 days - within the typical 510(k) review window.

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.

View all Optovue, Inc. devices

FDA 510(k) Submission Details - K122572

510(k) Number K122572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2012
Decision Date January 11, 2013
Days to Decision 141 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
31d slower than avg
Panel avg: 110d · This submission: 141d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ophthalmic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01600261 Completed Observational Industry-sponsored

iCam Clinical Validation Study

131
Patients (actual)
2
Sites
Condition studied Eye Disease
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor Optovue (industry)
Started 2012-04-01 → Primary completion 2012-05-01 → Completed 2012-06-01
Primary outcome
proportion of clinically useful images
Study completed - no results published. This trial concluded in 2012 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - HKI Camera, Ophthalmic, Ac-powered

All 136
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K122572.
TRC-NW8 NON-MYDRIATIC RETINAL CAMERA
K130289 · Topcon Corp. · May 2013
DIGITAL RETINAL CAMERA
K123208 · Canon Inc. -Medical Equipment Group · Mar 2013
TRC-NW300 NON-MYDRIATIC RETINAL CAMERA
K123460 · Topcon Medical Systems, Inc. · Feb 2013
LIPIVIEW OCULAR SURFACE INTERFEROMETER
K122481 · Tearscience, Inc. · Dec 2012
PANOPTIC
K121405 · Welch Allyn, Inc. · Dec 2012
DIGITAL EYE-FUNDUS CAMERA
K120982 · Medimaging Integrated Solutions, Inc. (Miis) · Sep 2012