Cleared Traditional

INNOVISION-P5

K250750 · Dk Medical Systems Co., Ltd. · Radiology

Jul 2025

Decision

128d

Days

Class 2

Risk

About This 510(k) Submission

K250750 is an FDA 510(k) clearance for the INNOVISION-P5, a System, X-ray, Mobile (Class II — Special Controls, product code IZL), submitted by Dk Medical Systems Co., Ltd. (Pyeongtaek-Si, KR). The FDA issued a Cleared decision on July 18, 2025, 128 days after receiving the submission on March 12, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number	K250750 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 12, 2025
Decision Date	July 18, 2025
Days to Decision	128 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF