Cleared Traditional

K170638 - Retina Workplace

K170638 is the FDA 510(k) clearance for Retina Workplace by Carl Zeiss Meditec, AG. It is a Class 2 Ophthalmic device (product code NFJ) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K170638 · Carl Zeiss Meditec, AG · Ophthalmic device
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Jun 2017
Decision
111d
Days
Class 2
Risk

K170638 is an FDA 510(k) clearance for the Retina Workplace. Classified as System, Image Management, Ophthalmic (product code NFJ), Class II - Special Controls.

Submitted by Carl Zeiss Meditec, AG (Jena, DE). The FDA issued a Cleared decision on June 21, 2017 after a review of 111 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 Carl Zeiss Meditec, AG devices

Submission Details

510(k) Number K170638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2017
Decision Date June 21, 2017
Days to Decision 111 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
1d slower than avg
Panel avg: 110d · This submission: 111d
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 27
Devices cleared under the same product code (NFJ) and FDA review panel - the closest regulatory comparables to K170638.
Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
K181016 · Welch Allyn, Inc. · Jul 2018
CALLISTO eye
K180858 · Carl Zeiss Meditec, AG · Jun 2018
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K173689 · Canon Inc. -Medical Equipment Group · Feb 2018
NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
K013694 · Nidek, Inc. · Nov 2002