Cleared Traditional

Optical Topography System ETG-4100 (K172492) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172492 · Hitachi Healthcare Americas · Neurology device
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Aug 2018
Decision
365d
Days
Class 2
Risk

K172492 is an FDA 510(k) clearance for the Optical Topography System ETG-4100. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Hitachi Healthcare Americas (Twinsburg, US). The FDA issued a Cleared decision on August 17, 2018 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.2700 - the FDA neurology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hitachi Healthcare Americas devices

Submission Details

510(k) Number K172492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2017
Decision Date August 17, 2018
Days to Decision 365 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
217d slower than avg
Panel avg: 148d · This submission: 365d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 Neurology devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 175
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K172492.
BB-613 Watch Oximeter
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K173368 · Shenzhen Coreray Technology, Ltd. · Aug 2018
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K173123 · Shenzhen Imdk Medical Technology Co., Ltd. · Aug 2018
Pulse Oximeter
K172616 · Beijing Safe Heart Technology , Ltd. · Jul 2018
Reusable SpO2 Sensors, Disposable SpO2 Sensors
K172981 · APK Technology Co., Ltd. · Jun 2018