INNOVISION-DXII— 510(k) K250790

Substantially Equivalent

Dk Medical Systems Co., Ltd.

FDA 510(k) clearance K250790 for INNOVISION-DXII, Substantially Equivalent on 2025-08-01. Applicant: Dk Medical Systems Co., Ltd..

Clearance details

Applicant: Dk Medical Systems Co., Ltd.
Product code: Code KPR
Advisory panel: Radiology
Date received: 2025-03-14
Decision date: 2025-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pyeongtaek-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.