EConsole1— 510(k) K231225

Substantially Equivalent

DRTECH Corporation

FDA 510(k) clearance K231225 for EConsole1, Substantially Equivalent on 2023-10-18. Applicant: DRTECH Corporation.

Clearance details

Applicant: DRTECH Corporation
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2023-04-28
Decision date: 2023-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.