Orthoscan VERSA Mini C-Arm— 510(k) K243452

Substantially Equivalent

Ziehm-Orthoscan, Inc.

FDA 510(k) clearance K243452 for Orthoscan VERSA Mini C-Arm, Substantially Equivalent on 2025-01-14. Applicant: Ziehm-Orthoscan, Inc..

Clearance details

Applicant: Ziehm-Orthoscan, Inc.
Product code: Code OXO
Advisory panel: Radiology
Date received: 2024-11-07
Decision date: 2025-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OXO

product code OXO

Death: 6
Injury: 163
Malfunction: 2,099
Other: 1
Total: 2,269

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.