INNOVISION-EXII— 510(k) K242119

Substantially Equivalent

Dk Medical System

FDA 510(k) clearance K242119 for INNOVISION-EXII, Substantially Equivalent on 2025-01-03. Applicant: Dk Medical System.

Clearance details

Applicant: Dk Medical System
Product code: Code KPR
Advisory panel: Radiology
Date received: 2024-07-19
Decision date: 2025-01-03
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.