Cleared Traditional

BONX805

K243864 · Bontech Co., Ltd. · Radiology

Sep 2025

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K243864 is an FDA 510(k) clearance for the BONX805, a System, X-ray, Mobile (Class II — Special Controls, product code IZL), submitted by Bontech Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on September 12, 2025, 269 days after receiving the submission on December 17, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number	K243864 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 17, 2024
Decision Date	September 12, 2025
Days to Decision	269 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF