INNOVISION-P5— 510(k) K250750

Name: FDA 510(k) clearance K250750
Creator: U.S. Food and Drug Administration
Published: 2025-07-18

Substantially Equivalent

Dk Medical Systems Co., Ltd.

FDA 510(k) clearance K250750 for INNOVISION-P5, Substantially Equivalent on 2025-07-18. Applicant: Dk Medical Systems Co., Ltd.. Device class: 2.

Clearance details

Applicant: Dk Medical Systems Co., Ltd.
Product code: Code IZL
Device class: Class 2
Regulation: 21 CFR 892.1720
Advisory panel: Radiology
Date received: 2025-03-12
Decision date: 2025-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pyeongtaek-Si, KR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.