Cleared Traditional

K181016 - Welch Allyn RetinaVue Network REF 90110...

K181016 is the FDA 510(k) clearance for Welch Allyn RetinaVue Network REF 90110... by Welch Allyn, Inc.. It is a Class 2 Ophthalmic device (product code NFJ) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K181016 · Welch Allyn, Inc. · Ophthalmic device
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Jul 2018
Decision
90d
Days
Class 2
Risk

K181016 is an FDA 510(k) clearance for the Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System. Classified as System, Image Management, Ophthalmic (product code NFJ), Class II - Special Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on July 16, 2018 after a review of 90 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 Welch Allyn, Inc. devices

Submission Details

510(k) Number K181016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2018
Decision Date July 16, 2018
Days to Decision 90 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
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 33
Devices cleared under the same product code (NFJ) and FDA review panel - the closest regulatory comparables to K181016.
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K173689 · Canon Inc. -Medical Equipment Group · Feb 2018
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K170638 · Carl Zeiss Meditec, AG · Jun 2017