HnX-P1, HnX-PB— 510(k) K251223

Substantially Equivalent

H&abyz Co., Ltd.

FDA 510(k) clearance K251223 for HnX-P1, HnX-PB, Substantially Equivalent on 2025-08-04. Applicant: H&abyz Co., Ltd..

Clearance details

Applicant: H&abyz Co., Ltd.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2025-04-21
Decision date: 2025-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yongin-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.