Cleared Traditional

GF85 (models GF85-3P, GF85-SP)

K242478 · Samsung Electronics Co., Ltd. · Radiology
Sep 2024
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K242478 is an FDA 510(k) clearance for the GF85 (models GF85-3P, GF85-SP), a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by Samsung Electronics Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on September 19, 2024, 29 days after receiving the submission on August 21, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K242478 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2024
Decision Date September 19, 2024
Days to Decision 29 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

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

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