Cleared Traditional

K242478 - GF85 (models GF85-3P

K242478 is the FDA 510(k) clearance for GF85 (models GF85-3P by Samsung Electronics Co., Ltd.. It is a Class 2 Radiology device (product code KPR) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K242478 · Samsung Electronics Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2024
Decision
29d
Days
Class 2
Risk

K242478 is an FDA 510(k) clearance for the GF85 (models GF85-3P, GF85-SP). 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 September 19, 2024 after a review of 29 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 K242478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 107d · This submission: 29d
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 164
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K242478.
uDR 780i
K241068 · Shanghai United Imaging Healthcare Co., Ltd. · Nov 2024
EXSYS DEXi (EXSYS DEXi-D401S-FRM)
K242847 · DRTECH Corporation · Oct 2024
Definium Pace Select ET
K242678 · Ge Hualun Medical Systems Co. , Ltd. · Oct 2024
EOSedge
K233920 · Eos Imaging · Aug 2024
EXSYS DEXi (EXSYS DEXi-D401S-FRM)
K233530 · DRTECH Corporation · Jul 2024
Radiography 7300 C
K233662 · Philips Medical Systems Dmc GmbH · Jun 2024