Cleared Traditional

K081797 - IMAGE STORAGE SYSTEM

K081797 is an FDA 510(k) clearance for IMAGE STORAGE SYSTEM, manufactured by Konan Medical, Inc.. The device is a Class 2 Ophthalmic device with product code NFJ cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K081797 · Konan Medical, Inc. · Ophthalmic device
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Jan 2009
Decision
211d
Days
Class 2
Risk

K081797 is an FDA 510(k) clearance for the IMAGE STORAGE SYSTEM, MODEL KSS-400. Classified as System, Image Management, Ophthalmic (product code NFJ), Class II - Special Controls.

Submitted by Konan Medical, Inc. (Hasbrouck Heights, US). The FDA issued a Cleared decision on January 22, 2009 after a review of 211 days - an extended review cycle.

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 Konan Medical, Inc. devices

FDA 510(k) Submission Details - K081797

510(k) Number K081797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2008
Decision Date January 22, 2009
Days to Decision 211 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
101d slower than avg
Panel avg: 110d · This submission: 211d
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.