Cleared Traditional

K151685 - GUA60A, GU60A-65

K151685 is an FDA 510(k) clearance for GUA60A, manufactured by Samsung Electronics Co., Ltd.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K151685 · Samsung Electronics Co., Ltd. · Radiology device
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Jul 2015
Decision
25d
Days
Class 2
Risk

K151685 is an FDA 510(k) clearance for the GUA60A, GU60A-65. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Samsung Electronics Co., Ltd. (Suwon-Si,, KR). The FDA issued a Cleared decision on July 17, 2015 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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

FDA 510(k) Submission Details - K151685

510(k) Number K151685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2015
Decision Date July 17, 2015
Days to Decision 25 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
82d faster than avg
Panel avg: 107d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 265
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K151685.
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