Cleared Traditional

K172492 - Optical Topography System ETG-4100

K172492 is an FDA 510(k) clearance for Optical Topography System ETG-4100, manufactured by Hitachi Healthcare Americas. The device is a Class 2 Neurology device with product code DQA cleared through the Traditional 510(k) pathway after a 365-day FDA review.

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

FDA 510(k) Submission Details - K172492

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.

DQA Device Classification - Class 2, Special Controls

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 453
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