PROMO— 510(k) K251443

Substantially Equivalent

DRGEM Corporation

FDA 510(k) clearance K251443 for PROMO, Substantially Equivalent on 2025-08-22. Applicant: DRGEM Corporation.

Clearance details

Applicant: DRGEM Corporation
Product code: Code IZL
Advisory panel: Radiology
Date received: 2025-05-09
Decision date: 2025-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gwangmyeong-Si, KR

Download summary PDF View on FDA.gov ↗

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.