MasteRad MiniX Mobile Digital Imaging System (Mini-X)— 510(k) K242731

Substantially Equivalent

Medicatech USA, Inc.

FDA 510(k) clearance K242731 for MasteRad MiniX Mobile Digital Imaging System (Mini-X), Substantially Equivalent on 2025-05-16. Applicant: Medicatech USA, Inc..

Clearance details

Applicant: Medicatech USA, Inc.
Product code: Code OWB
Advisory panel: Radiology
Date received: 2024-09-10
Decision date: 2025-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

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.