Cleared Traditional

K101935 - CENTERVUE DIGITAL RETINOGRAPHY SYSTEM

K101935 is an FDA 510(k) clearance for CENTERVUE DIGITAL RETINOGRAPHY SYSTEM, manufactured by Centervue S.P.A.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K101935 · Centervue S.P.A. · Ophthalmic device
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Oct 2010
Decision
107d
Days
Class 2
Risk

K101935 is an FDA 510(k) clearance for the CENTERVUE DIGITAL RETINOGRAPHY SYSTEM. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Centervue S.P.A. (Rome, IT). The FDA issued a Cleared decision on October 27, 2010 after a review of 107 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 Centervue S.P.A. devices

FDA 510(k) Submission Details - K101935

510(k) Number K101935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2010
Decision Date October 27, 2010
Days to Decision 107 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 110d · This submission: 107d
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 60
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K101935.
Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module
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DIGITAL RETINAL CAMERA, CR-1 MARK II
K090466 · Canon, Inc. · Mar 2009
CR-1
K080883 · Canon, Inc. · Apr 2008
CF-1
K063717 · Canon, Inc. · Jan 2007