Cleared Traditional

K171119 - GM85

K171119 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 28-day FDA review.

K171119 · Samsung Electronics Co., Ltd. · Radiology device
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May 2017
Decision
28d
Days
Class 2
Risk

K171119 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 May 12, 2017 after a review of 28 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Samsung Electronics Co., Ltd. devices

Submission Details

510(k) Number K171119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2017
Decision Date May 12, 2017
Days to Decision 28 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
79d faster than avg
Panel avg: 107d · This submission: 28d
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 117
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K171119.
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