TOPA12 Portable X-ray Unit— 510(k) K230581

Substantially Equivalent

Neuf, Inc.

FDA 510(k) clearance K230581 for TOPA12 Portable X-ray Unit, Substantially Equivalent on 2023-08-16. Applicant: Neuf, Inc..

Clearance details

Applicant: Neuf, Inc.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2023-03-02
Decision date: 2023-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suncheon-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.