Cleared Traditional

K220175 - GM85

K220175 is the FDA 510(k) clearance for GM85 by Samsung Electronics Co., Ltd.. It is a Class 2 Radiology device (product code IZL) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K220175 · Samsung Electronics Co., Ltd. · Radiology device
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Apr 2022
Decision
90d
Days
Class 2
Risk

K220175 is an FDA 510(k) clearance for the GM85. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Samsung Electronics Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on April 21, 2022 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Samsung Electronics Co., Ltd. devices

Submission Details

510(k) Number K220175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2022
Decision Date April 21, 2022
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 Radiology devices follow this clearance model.

Regulatory Peers - IZL System, X-ray, Mobile

All 116
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K220175.
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