Cleared Traditional

K093313 - SYNERGY

K093313 is an FDA 510(k) clearance for SYNERGY, manufactured by Topcon Medical Systems, Inc.. The device is a Class 2 Radiology device with product code NFJ cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K093313 · Topcon Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
41d
Days
Class 2
Risk

K093313 is an FDA 510(k) clearance for the SYNERGY. Classified as System, Image Management, Ophthalmic (product code NFJ), Class II - Special Controls.

Submitted by Topcon Medical Systems, Inc. (North Reading, US). The FDA issued a Cleared decision on December 2, 2009 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K093313

510(k) Number K093313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2009
Decision Date December 02, 2009
Days to Decision 41 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 107d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Radiology devices follow this clearance model.

Regulatory Consultant

Tuv Rheinland of North America, Inc.
TAMAS BORSAI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NFJ System, Image Management, Ophthalmic

All 52
Devices cleared under the same product code (NFJ) and FDA review panel - the closest regulatory comparables to K093313.
OPTOS ADVANCE
K113696 · Optos Plc. · May 2012
CARA
K110869 · Diagnos, Inc. · Jul 2011
OIS SYMPHONY IMAGE MANAGMENT SYSTEM
K110006 · Ophthalmic Imaging Systems · May 2011
MATCHEDFLICKER
K090266 · Eyeic Corporation · May 2009
FORUM
K090439 · Carl Zeiss Meditec, Inc. · Mar 2009
IMAGE STORAGE SYSTEM, MODEL KSS-400
K081797 · Konan Medical, Inc. · Jan 2009
K093313 · SYNERGY
Download PDF FDA Summary Topcon Medical System…