Cleared Traditional

K181629 - GC85A

K181629 is the FDA 510(k) clearance for GC85A by Samsung Electronics Co., Ltd.. It is a Class 2 Radiology device (product code KPR) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K181629 · Samsung Electronics Co., Ltd. · Radiology device
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Jul 2018
Decision
30d
Days
Class 2
Risk

K181629 is an FDA 510(k) clearance for the GC85A. 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 20, 2018 after a review of 30 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

Submission Details

510(k) Number K181629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2018
Decision Date July 20, 2018
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 169
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K181629.
Halifax Imaging Kit
K182880 · Halifax Biomedical, Inc. · Oct 2018
GC70
K182647 · Samsung Electronics Co., Ltd. · Oct 2018
GU60A, GU60A-65
K182622 · Samsung Electronics Co., Ltd. · Oct 2018
uDR 592h, uDR 596i
K181413 · Shanghai United Imaging Healthcare Co., Ltd. · Jun 2018
Ysio Max
K181279 · Siemens Medi Cal Solutions, Inc. · Jun 2018
GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85
K180543 · Samsung Electronics Co., Ltd. · May 2018