Cleared Traditional

INNOVISION-DXII

K250790 · Dk Medical Systems Co., Ltd. · Radiology

Aug 2025

Decision

140d

Days

Class 2

Risk

About This 510(k) Submission

K250790 is an FDA 510(k) clearance for the INNOVISION-DXII, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by Dk Medical Systems Co., Ltd. (Pyeongtaek-Si, KR). The FDA issued a Cleared decision on August 1, 2025, 140 days after receiving the submission on March 14, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number	K250790 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 2025
Decision Date	August 01, 2025
Days to Decision	140 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF