510(k) K170946— Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant

Substantially Equivalent

Skanray Technologies Private Limited

Clearance details

Applicant: Skanray Technologies Private Limited
Product code: Code OXO
Advisory panel: Radiology
Date received: 2017-03-30
Decision date: 2017-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mysore, IN

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.