Cleared Traditional

K171098 - AXIS Image Management System

K171098 is an FDA 510(k) clearance for AXIS Image Management System, manufactured by Sonomed, Inc.. The device is a Class 2 Ophthalmic device with product code NFJ cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K171098 · Sonomed, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
19d
Days
Class 2
Risk

K171098 is an FDA 510(k) clearance for the AXIS Image Management System. Classified as System, Image Management, Ophthalmic (product code NFJ), Class II - Special Controls.

Submitted by Sonomed, Inc. (New Hyde Park, US). The FDA issued a Cleared decision on May 2, 2017 after a review of 19 days - a notably fast clearance 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: 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 - K171098

510(k) Number K171098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2017
Decision Date May 02, 2017
Days to Decision 19 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
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
91d faster than avg
Panel avg: 110d · This submission: 19d
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 Ophthalmic devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
MARK JOB

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 K171098.
Ophthalmic Software Platform RX
K173689 · Canon Inc. -Medical Equipment Group · Feb 2018
IMAGEnet 6 Ophthalmic Data System
K171370 · Topcon Corporation · Nov 2017
Retina Workplace
K170638 · Carl Zeiss Meditec, AG · Jun 2017
Huvitz Imaging System
K161829 · Huvitz Co., Ltd. · Apr 2017
OptosAdvance 4.0 Software
K162039 · Optos Plc. · Feb 2017
Synergy ODM
K151952 · Topcon Medical Systems, Inc. · Oct 2015