Cleared Traditional

K110006 - OIS SYMPHONY IMAGE MANAGMENT SYSTEM

K110006 is an FDA 510(k) clearance for OIS SYMPHONY IMAGE MANAGMENT SYSTEM, manufactured by Ophthalmic Imaging Systems. The device is a Class 2 Ophthalmic device with product code NFJ cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K110006 · Ophthalmic Imaging Systems · Ophthalmic device
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May 2011
Decision
135d
Days
Class 2
Risk

K110006 is an FDA 510(k) clearance for the OIS SYMPHONY IMAGE MANAGMENT SYSTEM. Classified as System, Image Management, Ophthalmic (product code NFJ), Class II - Special Controls.

Submitted by Ophthalmic Imaging Systems (Sacramento, US). The FDA issued a Cleared decision on May 18, 2011 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 892.2050 - 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 Ophthalmic Imaging Systems devices

FDA 510(k) Submission Details - K110006

510(k) Number K110006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2011
Decision Date May 18, 2011
Days to Decision 135 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
25d slower than avg
Panel avg: 110d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFJ Device Classification - Class 2, Special Controls

Product Code NFJ System, Image Management, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - NFJ System, Image Management, Ophthalmic

All 42
Devices cleared under the same product code (NFJ) and FDA review panel - the closest regulatory comparables to K110006.
FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH
K122938 · Carl Zeiss Meditec, AG · Nov 2012
OPTOS ADVANCE
K113696 · Optos Plc. · May 2012
CARA
K110869 · Diagnos, Inc. · Jul 2011
FORUM
K090439 · Carl Zeiss Meditec, Inc. · Mar 2009
NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
K013694 · Nidek, Inc. · Nov 2002